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| ID | Type | Description | Link |
|---|---|---|---|
| 1K2CX001884-01A1 | Other Grant/Funding Number | VA CSR&D |
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This study is being performed to compare the effects of two alternate types of psychotherapy, Cognitive Behavior Therapy (CBT) and Emotional Awareness and Expression Therapy (EAET), for chronic musculoskeletal pain in older adults. In addition, the investigators will evaluate which patients respond better to each treatment and further investigate how each treatment works. CBT, which focuses on improving coping skills for pain, is the standard form of psychotherapy offered at VA. EAET instead focuses on understanding how life stress, relationships, and emotions may cause and perpetuate pain.
The investigators are performing the study because pain is a large problem among Veterans. Studies show that chronic pain affects as many as 50% of male Veterans and 75% of female Veterans. The investigators are focusing on older adult Veterans because they have the highest rates of chronic pain at VA, perhaps as high as 80%. The investigators are looking at psychotherapy in this study because VA, the Department of Defense, and the CDC recently recommended psychosocial treatments, such as psychotherapy, as first treatments for chronic pain, along with medications other than opioids (e.g., oxycodone). However, only one form of psychotherapy, CBT, is currently available in clinical practice at VA, and this study may provide evidence for making EAET available to Veterans as well.
The overarching goal of the proposed research is to learn how to optimize psychotherapy for those Veterans most in need and most likely to benefit from psychotherapy, older Veterans with chronic musculoskeletal pain. Chronic pain is a critical healthcare challenge, as the condition affects 50% of all Veterans and affects older Veterans most commonly, severely, and persistently. For years, chronic pain treatment has been notoriously difficult at VA and elsewhere, especially in light of the recent "opioid crisis," in which opioid analgesics, previously a mainstay of chronic pain treatment, have come under increased scrutiny. In response, CDC, VA/DoD, and some experts have called for enhancing and expanding psychosocial treatment options for chronic pain, such as psychotherapy, which are low risk for older Veterans who frequently have multiple medical comorbidities and are taking multiple medications.
Yet standard VA psychotherapy approaches, such as Cognitive Behavior Therapy (CBT), have shown modest benefits for Veterans on pain and other related outcomes, such as mood, anxiety, and sleep. In contrast, a novel psychotherapy approach, Emotional Awareness and Expression Therapy (EAET), has shown medium to large benefits for some chronic pain patients. Whereas CBT improves pain and negative emotion by teaching patients cognitive and behavioral coping skills, affecting brain regions that enhance "cognitive control" of pain, EAET operates primarily through emotion regulation, which is thought to influence brain regions and circuits that modulate both physical pain and emotion--a mechanism absent from existing approaches. The literature and the investigators' pilot data indicate that patients who express emotional distress at baseline, such as high anxiety and depressive symptoms, may be particularly likely to benefit from EAET's emotion regulation approach, whereas patients who express less emotional distress may derive more benefit from an approach like CBT, which does not require ready access to emotions.
The proposed randomized clinical trial tests the hypothesis that EAET is superior to CBT on reduction in mean pain severity and other outcomes derived from IMMPACT. To examine which patients are most likely to benefit, this research also tests whether greater baseline emotional distress (using measures of anxiety and depression) predicts stronger benefits from EAET and whether lower baseline emotional distress predicts stronger benefits from CBT. Finally, this research explores whether the benefits of EAET are mediated by improved emotion regulation, whether the benefits of CBT are mediated by improved cognitive and behavioral coping, and whether the benefits of both are mediated by a stronger working alliance. These mediators (e.g., Survey of Pain Attitudes, Working Alliance Inventory) were originally listed as outcomes in the trial registration, but they have been removed. The investigators plan to enroll 160 multi-ethnic/multi-racial older Veterans (age 60-95 years) with chronic musculoskeletal pain at the West Los Angeles VA Medical Center.
This research can introduce an additional, potentially more effective format of psychotherapy at VA so that more Veterans with chronic pain can respond. In addition, this research can lead to better treatment targeting and enhance the understanding of how psychotherapy treatments work. Finally, this research can facilitate the development of critical skills for the PI in psychotherapy research and pain management and enhance his ability to effect positive change for older Veterans.
Recruitment was resumed after the COVID-19 Administrative Hold was lifted in October 2020.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Emotional Awareness and Expression Therapy | Experimental | Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. |
|
| Cognitive Behavior Therapy | Active Comparator | Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Emotional Awareness and Expression Therapy | Behavioral | Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
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Inclusion Criteria:
Eligible Veterans are age 60 to 95 years old and have had at least 3 months of musculoskeletal pain, including the following conditions most likely to benefit from psychosocial intervention based on previous research:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brandon C Yarns, MD MS BME | VA Greater Los Angeles Healthcare System, West Los Angeles, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Greater Los Angeles Healthcare System, West Los Angeles, CA | West Los Angeles | California | 90073-1003 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38869899 | Result | Yarns BC, Jackson NJ, Alas A, Melrose RJ, Lumley MA, Sultzer DL. Emotional Awareness and Expression Therapy vs Cognitive Behavioral Therapy for Chronic Pain in Older Veterans: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jun 3;7(6):e2415842. doi: 10.1001/jamanetworkopen.2024.15842. |
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Of 126 enrolled, 126 were randomized to treatment.
Participants were recruited from outpatient clinics at VA Greater Los Angeles, letter-based recruitment based on a search of data from the VA Corporate Warehouse, and self-referral from flyers. The first participants was enrolled on May 16, 2019, and the last participant was enrolled on February 1, 2023. Recruitment was paused from March 20, 2020, until February 4, 2021, due to COVID-19 related administrative holds.
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| ID | Title | Description |
|---|---|---|
| FG000 | Emotional Awareness and Expression Therapy | Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. |
| FG001 | Cognitive Behavior Therapy | Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
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| ID | Title | Description |
|---|---|---|
| BG000 | Emotional Awareness and Expression Therapy | Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Pain Severity | Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
|
AEs, SAEs, and UAPs were collected from the time of study entry until the end of study participation, an average of 8 months.
Adverse events were reported to the VA Clinical Sciences Research and Development Data Monitoring Committee and the local IRB
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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 | Emotional Awareness and Expression Therapy | Seeks to reduce physical (e.g., pain) and emotional (e.g., depression, anxiety) symptoms by helping individuals become aware of their emotions, express them, and resolve emotional conflicts. It will use techniques such as writing about stress, role playing how to handle difficult relationships, recognizing and expressing anger and other feelings, and being more open with others. Emotional Awareness and Expression Therapy: Focus on emotions, writing about stress, assertiveness training, role playing new ways to handle relationships, and sharing feelings and experiences with others. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute decompensated heart failure | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Temporary worsening of pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Brandon C. Yarns | VA Greater Los Angeles Healthcare System | 310-478-3711 | brandon.yarns@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 28, 2020 | Aug 12, 2024 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 21, 2020 | Nov 14, 2023 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D059352 | Musculoskeletal Pain |
| D059350 | Chronic Pain |
| D009140 | Musculoskeletal Diseases |
| ID | Term |
|---|---|
| D009135 | Muscular Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| ID | Term |
|---|---|
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Two-Group Parallel Comparison Trial
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|
| Cognitive Behavior Therapy | Behavioral | Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. |
|
|
| Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction) | Overall satisfaction is a single item on the Satisfaction with Therapy and Therapist Scale-Revised scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction) with higher scores indicating a better outcome. | 10 weeks |
| PROMIS-Pain Interference Short Form 8a v1.0 | Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| PROMIS-Pain Interference Short Form 8a v1.0 | Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
| PROMIS-Depression Short Form | Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| PROMIS-Depression Short Form | Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
| PROMIS-Anxiety Short Form | Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| PROMIS-Anxiety Short Form | Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
| PTSD Checklist for DSM-5 | Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| PTSD Checklist for DSM-5 | Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
| NIH Toolbox-Life Satisfaction Short Form | Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome. | Change from baseline to 10 weeks |
| NIH Toolbox-Life Satisfaction Short Form | Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome. | Change from baseline to 20 weeks |
| PROMIS-Sleep Disturbance Short Form | Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| PROMIS-Sleep Disturbance Short Form | Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
| PROMIS-Fatigue Short Form | Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Change from baseline to 10 weeks |
| PROMIS-Fatigue Short Form | Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Change from baseline to 20 weeks |
| Patient's Global Impression of Change Scale | Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome. | Change from baseline to 10 weeks |
| Patient's Global Impression of Change Scale | Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome. | Change from baseline to 20 weeks |
| Percentage of Participants With at Least 30% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 . Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is 30% lower than at baseline. | Change from baseline to 10 weeks |
| Percentage of Participants With at Least 30% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 30% lower than at baseline. | Change from baseline to 20 weeks |
| Percentage of Participants With at Least 50% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 50% lower than at baseline. | Change from baseline to 10 weeks |
| Percentage of Participants With at Least 50% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 50% lower than at baseline. | Change from baseline to 20 weeks |
| Percentage of Participants With at Least 70% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 70% lower than at baseline. | Change from baseline to 10 weeks |
| Percentage of Participants With at Least 70% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 70% lower than at baseline. | Change from baseline to 20 weeks |
| BG001 | Cognitive Behavior Therapy | Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Marital status | Count of Participants | Participants |
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| Education level | Count of Participants | Participants |
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| Pain duration | Mean | Standard Deviation | years |
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| No. prescribed opioids at baseline | Count of Participants | Participants |
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| Any psychiatric diagnosis | Count of Participants | Participants |
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| VA service-connected for PTSD | Count of Participants | Participants |
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| No. non-pain chronic medical conditions | Mean | Standard Deviation | conditions |
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| No. prescription medications | Mean | Standard Deviation | medications |
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| Mini-Mental State Examination Scores | Sum of 30 questions evaluating cognition (i.e., orientation, verbal memory registration, short-term memory recall, working memory, language, and visuospatial abilities), yielding a total score between 0 and 30 with higher scores indicating better cognition. | Mean | Standard Deviation | units on a scale |
|
| Back pain | Count of Participants | Participants |
|
| OG001 | Cognitive Behavior Therapy | Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. |
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| Secondary | Pain Severity | Average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | Satisfaction With Therapy and Therapist Scale-Revised (Overall Satisfaction) | Overall satisfaction is a single item on the Satisfaction with Therapy and Therapist Scale-Revised scored 1-5 (1 = maximum dissatisfaction; 5 = maximum satisfaction) with higher scores indicating a better outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | 10 weeks |
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| Secondary | PROMIS-Pain Interference Short Form 8a v1.0 | Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | PROMIS-Pain Interference Short Form 8a v1.0 | Sum of eight self-report items assessing interference of pain with daily activities over the past 7 days. Items range from 1-5 (1 = no interference; 5 = maximum interference), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | PROMIS-Depression Short Form | Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | PROMIS-Depression Short Form | Sum of eight self-report items assessing depression and emotional distress over the past 7 days. Items range from 1-5 (1 = never feeling a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | PROMIS-Anxiety Short Form | Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | PROMIS-Anxiety Short Form | Sum of seven self-report items assessing anxiety over the past 7 days. Items range from 1-5 (1 = never experiencing a type of distressing emotion; 5 = always feeling that emotion), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | PTSD Checklist for DSM-5 | Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy when PTSD symptoms were assessed; groups 3-10) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | PTSD Checklist for DSM-5 | Sum of twenty self-report items assessing PTSD according to the frequency in which symptoms are experienced over the past month. Items range from 0-4 (0 = not at all; 1 = a little bit; 2 = moderately; 3 = quite a bit; 4 = extremely), yielding a total score between 0 and 80 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy when PTSD symptoms were assessed; groups 3-10) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | NIH Toolbox-Life Satisfaction Short Form | Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | NIH Toolbox-Life Satisfaction Short Form | Sum of five self-report items assessing general life satisfaction. Items range from 1-5 (1 = no satisfaction; 5 = maximum satisfaction), yielding a total score between 5 and 25 with higher scores indicating a better outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | PROMIS-Sleep Disturbance Short Form | Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | PROMIS-Sleep Disturbance Short Form | Sum of eight self-report items assessing sleep disturbance over the past 7 days. Items range from 1-5 (1 = no sleep disturbance; 5 = maximum sleep disturbance), yielding a total score between 8 and 40 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | PROMIS-Fatigue Short Form | Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | PROMIS-Fatigue Short Form | Sum of seven self-report items assessing fatigue over the past 7 days. Items range from 1-5 (1 = no fatigue; 5 = maximum fatigue), yielding a total score between 7 and 35 with higher scores indicating a worse outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | Patient's Global Impression of Change Scale | Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 10 weeks |
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| Secondary | Patient's Global Impression of Change Scale | Patient rates on a single item with a scale of 1-7 the change (if any) they've experienced since beginning treatment in the study (1 = no change or condition has worsened; 7 = a great deal better and a considerable improvement that has made all the difference) with higher scores indicating a better outcome. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Mean | 95% Confidence Interval | score on a scale | Change from baseline to 20 weeks |
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| Secondary | Percentage of Participants With at Least 30% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10 . Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is 30% lower than at baseline. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline to 10 weeks |
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| Secondary | Percentage of Participants With at Least 30% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 30% lower than at baseline. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline to 20 weeks |
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| Secondary | Percentage of Participants With at Least 50% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 50% lower than at baseline. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline to 10 weeks |
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| Secondary | Percentage of Participants With at Least 50% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 50% lower than at baseline. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline to 20 weeks |
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| Secondary | Percentage of Participants With at Least 70% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 10 weeks, and the two scores are compared to see if mean pain severity at 10 weeks is at least 70% lower than at baseline. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline to 10 weeks |
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| Secondary | Percentage of Participants With at Least 70% Improvement in Pain Severity | Mean pain severity is calculated from an average of 4 self report items: current pain, worst pain over the last 7 days, least pain over the last 7 days, and average pain over the last 7 days. Each item is scored 0-10 (0 = no pain; 10 = pain as bad as can be), yielding a total score between 0 and 10. Mean pain severity is calculated at baseline and 20 weeks, and the two scores are compared to see if mean pain severity at 20 weeks is at least 70% lower than at baseline. | Intent to Treat Population (all participants assigned to Emotional Awareness and Expression Therapy or Cognitive Behavior Therapy) | Posted | Number | 95% Confidence Interval | percentage of participants | Change from baseline to 20 weeks |
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| 1 |
| 66 |
| 2 |
| 66 |
| 10 |
| 66 |
| EG001 | Cognitive Behavior Therapy | Seeks to help individuals function better and improve symptoms by teaching various cognitive and behavioral skills to manage symptoms. It will use techniques such as relaxation training, engaging in pleasant activities, pacing yourself, and changing unhelpful ways of thinking. Cognitive Behavior Therapy: Focus on cognitive and behavioral skills, such as relaxation, increasing pleasant activities, pacing, and changing ways of thinking. | 1 | 60 | 1 | 60 | 5 | 60 |
| Hospitalized for worsening chronic rib pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Urgent cholecystectomy | Gastrointestinal disorders | Systematic Assessment |
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| Temporary worsening of depression | Psychiatric disorders | Systematic Assessment |
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| Hematuria | Renal and urinary disorders | Systematic Assessment |
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| Rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Palpitations | Cardiac disorders | Systematic Assessment |
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| Abdominal pain | Gastrointestinal disorders | Systematic Assessment |
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| COVID-19 | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
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| Fall | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Retinal detachment | Eye disorders | Systematic Assessment |
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Not provided
Not provided
| D013568 |
| Pathological Conditions, Signs and Symptoms |