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| ID | Type | Description | Link |
|---|---|---|---|
| R01AT008559-02S1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Complementary and Integrative Health (NCCIH) | NIH |
| The University of Queensland | OTHER |
| Medical University of South Carolina | OTHER |
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This project will increase our understanding of the mechanisms underlying changes in opioid medication use associated with three psychosocial chronic pain (CP) treatments. These treatments are: (1) Cognitive Therapy (CT), (2) Mindfulness Meditation (MM), and (3) Behavioral Activation (BA). The sample will be adults with CP who are at risk of opioid misuse. The purpose of this study is to understand the specific ways these treatments work for reducing opioid use. In addition, the investigators are interested in examining moderators of treatment response. The findings will potentially inform the future streamlining of psychosocial treatments, as well as the development of algorithms for matching individuals with CP who are at risk for opioid misuse to the specific treatment most likely to efficiently optimize benefit.
This study involves participating in eight videoconference group treatment sessions and telephone interviews over the course of approximately eight to nine months. All study procedures will take place over videoconferencing computer software, online, or by telephone. There are no in-person visits for the study. Participants wear an activity monitor for about two and a half months starting two weeks before treatment begins. They will also complete brief online surveys twice a day, once in the morning and once in the evening, for about two and a half months starting two weeks before treatment begins. These surveys will be completed on a computer, tablet, or smartphone.
Extended Assessments
During the study, participants would also complete four extended assessments with a research staff member. The first interview is completed before treatment begins, the second is completed after treatment ends, the third is completed three months after treatment ends, and the fourth and final is completed six months after treatment ends. The first two extended assessments (Pre- and Post-Treatment) are completed with a research staff member verbally over the telephone. The final two extended assessments (3-month and 6-month Follow-up) may be completed either with a research staff member verbally over the telephone or independently online.
Online Surveys
About two weeks before treatment starts, participants begin doing brief (~2-5 minutes) online surveys twice a day. The online surveys can be completed on a smartphone, tablet, laptop, or desktop computer. Automated notifications in the morning and in the evening remind the participant to complete the brief survey twice a day.
Activity Monitor
Participants wear an activity monitor 24 hours a day for the 2.5-month Monitoring Period (which spans two weeks before treatment to one month after treatment). The activity monitor is worn on the non-dominant wrist, like a wristwatch.
Weekly Interviews
Beginning two weeks prior to treatment, participants will be contacted weekly by a staff member to complete a telephone survey. Participants complete 10 total surveys over the course of 10 weeks, concluding about one month after treatment ends. Each survey takes approximately 10-15 minutes.
Treatment
Participants are randomly assigned to one of the three treatment groups. Treatment consists of eight group treatment sessions completed remotely over a videoconferencing platform. There will be, on average, two sessions per week, and each session will take up to 90 minutes. Each treatment session will take place over the internet on a computer, tablet, or smartphone using the videoconference application. Each session will be led by the same study clinician, who is a trained clinical psychologist. Participants will be required to use a video camera and audio through either a microphone or phone for each group treatment session.
All three treatment interventions will involve educating participants about pain, discussing the impact of pain, and discussing different ways to manage it in hopes of decreasing pain and its impact. The three treatments are: (1) Mindfulness Meditation, (2) Cognitive Therapy, and (3) Behavioral Activation (BA).
Each treatment intervention will have home practice activities to complete between sessions. Home practice activities may include, but are not limited to, creating thought records, listening to pre-recorded guided practices, and keeping track of activities and goals. Participants also receive a treatment workbook with materials to refer to and discuss during the group sessions as well as additional materials to read between sessions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cognitive Therapy (CT) Condition | Active Comparator | Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. |
|
| Mindfulness Meditation (MM) Condition | Active Comparator | Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. |
|
| Behavioral Activation (BA) Condition | Active Comparator | Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cognitive Therapy (CT) | Behavioral | The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change). | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Pain Interference (Micro-level) | Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Primary Mechanism Variable Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear time from the analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score theoretically is zero, with no theoretical maximum score. Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mark Jensen, Ph.D. | University of Washington | Principal Investigator |
| Melissa Day, Ph.D. | The University of Queensland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Washington, Ninth and Jefferson Building | Seattle | Washington | 98104 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41230568 | Result | Day MA, Ciol MA, Ehde DM, Mendoza ME, Borckardt J, Newman AK, Chan JF, Friedly JL, Reed DE 2nd, Drever SA, Burns J, Thorn BE, Jensen MP. The Effects of Psychological Treatments for Chronic Pain on Reducing Opioid Use in People at Risk for Opioid Misuse: A Randomized Feasibility Trial. Pain Pract. 2026 Jan;26(1):e70107. doi: 10.1111/papr.70107. |
| Label | URL |
|---|---|
| Study website | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| VIV00012515 | Individual Participant Data Set | View IPD |
We will make available to interested researchers a data file containing de-identified data used for each published article at the time the article is accepted for publication. The data will be de-identified to remove any variables from which it would be possible to identify any individual participants. Specifically, we will create a data file that includes all variables used in the published article and a list of the variables in the data file (along with variable labels) and mail to investigators who request the data a copy of: (1) the published article (which will describe the source of the data); (2) the variable list/variable labels; and (3) a CD of the data set (as an SPSS.sav file). Note, though, even though any data files that we share will be stripped of identifiers prior to release for sharing, it remains possible those who access the data could potentially use deduction to identify participants with unusual characteristics or combinations of unusual characteristics.
The data used for the analyses for any papers published will become available to interested researchers by request after that article is published. Those data will continue to be available for at least five years following the publication of the article.
We will make the data and associated documentation available to users only under a data-sharing agreement that provides for: (1) a commitment to using the data only for research purposes and not to identify any individual participant; (2) a commitment to securing the data using appropriate computer technology; and (3) a commitment to destroying or returning the data after analyses are completed.
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N=288 participants were excluded before randomization with 254 not meeting inclusion criteria, 25 unable to be contacted, and 9 declining participation.
Potential participants were identified primarily via ResearchMatch.org and via coding lists derived from medical records of UW Medicine patients. Other sources of recruitment included social media, the UW Rehabilitation Medicine departmental research participant pool, posted flyers in pain and rehabilitation clinics, clinician referrals, news releases with the UW Newsroom, and a variety of national recruitment strategies.
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| ID | Title | Description |
|---|---|---|
| FG000 | Cognitive Therapy (CT) Condition | Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. |
| FG001 | Mindfulness Meditation (MM) Condition | Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. |
| FG002 | Activation Skills (AS) Condition | Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Cognitive Therapy (CT) Condition | Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts, recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. Cognitive Therapy (CT): The cognitive-restructuring technique will be used to help participants recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change in Morphine Milligram Equivalent (MME) Average Daily Dose | Respondents were asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at the time of each telephone assessment. An average daily MME dose taken in the past week was computed for each assessment point, and a categorical variable was calculated to assess change throughout the trial (increase dose, decrease dose, no change). | Intent to treat | Posted | Number | participants | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
|
All participants were monitored/assessed for adverse events from enrollment through study completion, which was an average of 9 months.
Adverse events (AEs) were self-reported by participants and documented in an electronic regulatory event. The majority of AEs reported by participants were conveyed to researchers without prompt. AE monitoring occurred at the beginning of each treatment session with therapists asking if anyone had any negative effects attributed to the treatment. Any concerns that met the definition of an AE were documented. AEs were monitored/assessed without regard to the specific Adverse Event Term.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cognitive Therapy (CT) Condition | Participants randomized to this arm will be taught to recognize the relationships between thoughts, feelings, behaviors, and pain. This technique will help participants: (1) identify negative or unrealistic automatic thoughts; (2) evaluate automatic thoughts for accuracy, identify sources of distorted thoughts; recognize the connection between automatic thoughts and emotional/physical shifts; (3) challenge negative, distorted automatic thoughts via "weighing the evidence"; (4) develop new realistic alternative cognitive appraisals; and (5) practice applying new rational appraisals and beliefs. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hospitalization related to new infection/illness | Infections and infestations | Non-systematic Assessment | Not study related |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increase in existing chronic pain symptoms related to a study procedure | Social circumstances | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Melissa Day, Co-Principal Investigator | The University of Queensland | +61 7 3365 6421 | m.day@uq.edu.au |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Mar 7, 2022 | Jul 25, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 23, 2024 | Jul 25, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 10, 2022 | Jul 25, 2024 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D064866 | Mindfulness |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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| Rush University |
| OTHER |
A randomized 3-group, 90-subject clinical trial to test the mediators and moderators of cognitive therapy, mindfulness meditation, and behavioral activation on individuals with heterogeneous chronic pain conditions who are at risk for opioid misuse.
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| Mindfulness Meditation (MM) | Behavioral | Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position. |
|
| Behavioral Activation (BA) | Behavioral | Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. |
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| Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
| Change in Affect (Micro-level) | Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
| Change in Physical Function | Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses are summed and the raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Sleep Quality | Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Pain Interference (Macro-level) | Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Affect (Macro-level) | Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| ActiGraph worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported |
| Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Primary Mechanism Variable Change in non-judgment will be measured with 4 items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
| Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
| Change in Pain Intensity (Mechanism, Micro-level) | Primary Mechanism Variable Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
| Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Change in depression and anxiety will be measured with the respective Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms. Responses were summed for a total raw score for depression and anxiety. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of depression and anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Activity Level (Self-report Mechanism, EMA) | Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The daily EMA items asked how many times that day did the participant engage in >15mins of strenuous exercise, >15mins of moderate exercise and >15mins of mild exercise. The total frequencies for each category for a week were summed, and this scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
| Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants were asked how many times in the past 7-days did they engage in >15mins of strenuous exercise, >15mins of moderate exercise and >15mins of mild exercise. This scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Primary Mechanism Variable Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. The full 6-item scale will be used. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
| Change in Pain Intensity (Mechanism, Macro-level) | Primary Mechanism Variable Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
IPD data and supporting information uploaded to Vivli.org |
| BG001 | Mindfulness Meditation (MM) Condition | Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position. |
| BG002 | Behavioral Activation (BA) Condition | Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. |
| BG003 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Number | participants |
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| Region of Enrollment | Number | participants |
|
| Baseline MME | Respondents will be asked to provide dosages and frequency of use of any opioid medications taken in the past seven days at baseline. An average daily MME dose taken in the past week will be computed. | Mean | Standard Deviation | Morphine milligram equivalent |
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| OG001 | Mindfulness Meditation (MM) Condition | Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. Mindfulness Meditation (MM): Participants will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. A standard script will be implemented by the clinician, and participants will be seated in a comfortable yet alert position. |
| OG002 | Behavioral Activation (BA) Condition | Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. Behavioral Activation (BA): Participants will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. |
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| Secondary | Change in Pain Interference (Micro-level) | Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
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| Secondary | Change in Affect (Micro-level) | Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
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| Secondary | Change in Physical Function | Change in extent of physical function will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form-4A. Responses are summed and the raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of physical function. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Secondary | Change in Sleep Quality | Change in sleep quality will be measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form-4A. Responses from each item will be summed. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate more self-reported sleep disturbance. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Other Pre-specified | Change in Activity Level (Actigraph, Vector Magnitude Average Counts - Mechanism) | Primary Mechanism Variable Change in activity level will be measured by an actigraphy device worn by the participant measuring activity level. In this study, we used the vector magnitude average counts variable, which is the average of all activity counts recorded per minute that the device was worn (i.e., it removes non-wear time from the analysis). Higher activity counts indicate higher intensity activities that day; the minimum possible score theoretically is zero, with no theoretical maximum score. Slopes were calculated by computing the linear regression slopes for the Actigraph collected activity counts. | Intent to treat | Posted | Mean | Standard Deviation | activity counts | ActiGraph worn daily during 4-week treatment period, early treatment (baseline-2 weeks) and late treatment (2-4 weeks) reported |
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| Other Pre-specified | Change in Non-Judgment (Cognitive Process Mechanism, Micro-level) | Primary Mechanism Variable Change in non-judgment will be measured with 4 items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
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| Other Pre-specified | Change in Pain Catastrophizing (Cognitive Content Mechanism, Micro-level) | Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
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| Other Pre-specified | Change in Pain Intensity (Mechanism, Micro-level) | Primary Mechanism Variable Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. For the EMA data, slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
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| Other Pre-specified | Change in Depression and Anxiety Severity (Mechanism, Macro-level) | Change in depression and anxiety will be measured with the respective Patient-Reported Outcomes Measurement Information System (PROMIS) Short Forms. Responses were summed for a total raw score for depression and anxiety. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of depression and anxiety. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Secondary | Change in Pain Interference (Macro-level) | Change in pain interference with different activities/aspects of life will be measured with five items from the Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference item bank. Responses from each item will be summed and converted to a total T-score with a mean of 50 and a standard deviation of 10. Higher scores indicate more self-reported pain interference with different activities/aspects of life. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Secondary | Change in Affect (Macro-level) | Change in affect will be measured with the Positive and Negative Affect Schedule (PANAS). When assessed via phone, responses from the positive affect items will be summed for a total positive score ranging from 5-25 while responses from the negative affect items will be separately summed for a total negative score ranging from 5-25. When assessed with EMA, total scores will range from 1-5 for each affect schedule. A higher positive affect sum score indicates more self-reported positive affect while a lower negative affect sum score indicates less self-reported negative affect. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Other Pre-specified | Change in Activity Level (Self-report Mechanism, EMA) | Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). The daily EMA items asked how many times that day did the participant engage in >15mins of strenuous exercise, >15mins of moderate exercise and >15mins of mild exercise. The total frequencies for each category for a week were summed, and this scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Slopes (reported unit of measure) were calculated by computing the linear regression slopes, which are equivalent in meaning and magnitude to change scores. | Intent to treat | Posted | Mean | Standard Deviation | scores on a scale | Assessed via EMA twice daily during 4-week treatment period, early treatment (1-2 weeks) and late treatment (3-4 weeks) reported |
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| Other Pre-specified | Change in Activity Level (Self-report Mechanism, Telephone Assessed) | Secondary Mechanism Variable Self-reported change in activity level will be measured via the Godin Leisure-Time Exercise Questionnaire (GLTEQ). Participants were asked how many times in the past 7-days did they engage in >15mins of strenuous exercise, >15mins of moderate exercise and >15mins of mild exercise. This scoring formula was applied to calculate overall units of activity: Activity Score = (9 x Freq. of Strenuous)+(5 x Freq. of Moderate)+(3 x Freq. of Mild). The lowest possible score is zero, while no theoretical maximum score exists. Higher scores indicate higher levels of activity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Other Pre-specified | Change in Non-Judgment (Cognitive Process Mechanism, Macro-level) | Primary Mechanism Variable Change in non-judgment will be measured with items from the Pain-Related Cognitive Process Questionnaire (PCPQ) Non-Judgmental Scale. The full 6-item scale will be used. Items will be averaged for a mean score from 0-4. Higher mean PCPQ scores indicate higher frequencies of using the adaptive cognitive process of non-judgment in responding to pain. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Other Pre-specified | Change in Pain Catastrophizing (Cognitive Content Mechanism, Macro-level) | Primary Mechanism Variable Change in pain catastrophizing will be measured with items from the University of Washington (UW) Concerns About Pain (CAP) item bank. Responses from the CAP were summed for a total raw score. The raw scores are then converted to T-Scores, with a mean of 50 and a SD of 10. Higher scores indicate higher levels of catastrophizing. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| Other Pre-specified | Change in Pain Intensity (Mechanism, Macro-level) | Primary Mechanism Variable Change in pain intensity of chronic pain will be measured using a 0-10 numerical rating scale. Participants will be asked to choose a number from 0-10 that best represents their pain intensity. Higher scores indicate higher levels of self-reported pain intensity. Change scores were then calculated for the pre- and post-treatment and 3-month and 6-month follow-up data. | Intent to treat | Posted | Mean | Standard Deviation | change score on a scale | Collected via phone at pre-treatment (baseline), post-treatment (approximately one month after), and at 3- and 6-months post-treatment (treatment lasted approximately 4 weeks) |
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| 0 |
| 31 |
| 2 |
| 31 |
| 15 |
| 31 |
| EG001 | Mindfulness Meditation (MM) Condition | Participants randomized to this arm will receive training in mindfulness meditation, specifically Vipassana, which is the form of meditation typically implemented in mindfulness research. With this technique, the emphasis is placed upon developing focused attention on an object of awareness, e.g., the breath. This focus is then expanded to include a more open, non-judgmental monitoring of any sensory, emotional, or cognitive events. | 0 | 29 | 0 | 29 | 15 | 29 |
| EG002 | Behavioral Activation (BA) Condition | Participants randomized to this arm will be educated about the role of inactivity and behavioral avoidance in chronic pain and functioning. They will learn how to be aware of the activities they avoid because of pain, and how to set effective goals so that, step by step, they can start being more active and resume some activities they enjoyed in the past but are currently avoiding. Explanation and practice of a set of specific skills - including appropriate pacing skills - to facilitate an increase in appropriate activity level will be provided. | 1 | 31 | 4 | 31 | 19 | 31 |
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| Hospitalization due to new/existing respiratory illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not study related |
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| Hospitalization due to new/existing immune system illness | Immune system disorders | Non-systematic Assessment | Not study related |
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| Hospitalization related to a surgery/procedure | Surgical and medical procedures | Non-systematic Assessment | Not study related |
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| Hospitalization related to suicidal ideation | Psychiatric disorders | Non-systematic Assessment | Not study related |
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| Hospitalization due to illness of multiple organ systems | General disorders | Non-systematic Assessment | Not study related |
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| Increase in pain due to new injury/accident | Injury, poisoning and procedural complications | Non-systematic Assessment | Not study related |
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| New/worsening symptoms related to medical procedure/treatment | Injury, poisoning and procedural complications | Non-systematic Assessment | Not study related |
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| New/worsening skin irritation/rash related to wearing study ActiGraph device | Skin and subcutaneous tissue disorders | Non-systematic Assessment |
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| New/worsening respiratory symptoms/illness | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Not study related |
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| New/worsening symptoms related to the endocrine system | Endocrine disorders | Non-systematic Assessment | Not study related |
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| New/worsening psychological discomfort related to a study procedure | Psychiatric disorders | Non-systematic Assessment |
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| New/worsening gastrointestinal symptoms/illness | Gastrointestinal disorders | Non-systematic Assessment | Not study related |
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| Increase in existing chronic pain symptoms | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Not study related |
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| New/worsening sleep problem | Nervous system disorders | Non-systematic Assessment | Not study related |
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| New/worsening headache/migraine | Nervous system disorders | Non-systematic Assessment | Not study related |
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| New/worsening symptoms related to multiple organ systems | General disorders | Non-systematic Assessment | Not study related |
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| New surgery/medical procedure | Surgical and medical procedures | Non-systematic Assessment | Not study related |
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| New/worsening infection | Infections and infestations | Non-systematic Assessment | Not study related |
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| New neoplasm | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Not study related |
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| New/worsening urinary illness/infection | Renal and urinary disorders | Non-systematic Assessment | Not study related |
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| New/worsening kidney related symptoms/illness | Renal and urinary disorders | Non-systematic Assessment | Not study related |
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| New/worsening neurological symptoms/illness (not migraine) | Nervous system disorders | Non-systematic Assessment | Not study related |
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| Victim of assault | Injury, poisoning and procedural complications | Non-systematic Assessment | Not study related |
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| Adverse reaction related to treatment/medication | Injury, poisoning and procedural complications | Non-systematic Assessment | Not study related |
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| New/worsening cardiovascular symptoms/illness | Cardiac disorders | Non-systematic Assessment | Not study related |
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| New/worsening psychological distress | Psychiatric disorders | Non-systematic Assessment | Not study related |
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Not provided
Not provided
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| Positive Affect, late treatment |
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| Negative Affect, late treatment |
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| Change from pre- to 6 months post-treatment |
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| Change from pre- to 6 months post-treatment |
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| Late treatment (at 2 weeks to 4 weeks) |
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| Pre- to 3 months post-treatment change in Depression |
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| Pre- to 3 months post-treatment change in Anxiety |
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| Pre- to 6 months post-treatment change in Depression |
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| Pre- to 6 months post-treatment change in Anxiety |
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| Change from pre- to 6 months post-treatment |
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| Positive Affect, change from pre- to 3 months post-treatment |
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| Negative Affect, change from pre- to 3 months post-treatment |
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| Positive Affect, change from pre- to 6 months post-treatment |
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| Negative Affect, change from pre- to 6 months post-treatment |
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| Change from pre- to 6 months post-treatment |
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| Change from pre- to 6 months post-treatment |
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| Change from pre- to 6 months post-treatment |
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| Pre- to 6 months post-treatment change |
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