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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA040968 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
| National Institutes of Health (NIH) | NIH |
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The current study will modify an already existing therapy for individuals with substance use disorders to address Post Traumatic Stress Disorder (PTSD) in women enrolled in substance use disorders (SUD) treatment who suffer with both PTSD and SUD. Mindfulness meditation has been shown to help individuals to cope with stress and regulate emotions. Through meditation practice women will experience less distress related to PTSD symptoms and reduced substance use in response to emotional triggers. Women enrolled in intensive SUD treatment at a community program will be randomized to receive either 8 weeks of 90 minute Mindfulness Based Relapse Prevention (MBRP) group sessions plus treatment as usual (TAU) or TAU alone. The MBRP group sessions will replace 90 minutes of TAU group therapy. Measures of feasibility of implementation, acceptance and adherence will be obtained. Preliminary efficacy for substance use and PTSD symptom severity will be measured at post treatment and at 3- and 6- months' follow-up.
This randomized controlled pilot study will evaluate the feasibility and preliminary efficacy of MBRP plus usual community treatment as usual (TAU) compared to TAU alone (TAU) for women with substance use disorders(SUD) and PTSD enrolled in community substance abuse treatment. Participants will be randomized to eight weekly 90-minute, mixed individual and group-based MBRP in addition to TAU or TAU alone. The eight sessions of MBRP will replace 8 sessions of seeking safety (SS); a trauma focused integrated therapy currently implemented in TAU. Outcomes assessed will be:
Recruitment of participants will primarily take place a community treatment program treating women with co-occurring PTSD and SUD.
Following therapist training, certification and piloting, eligible women will be invited to participate in the study. Interested potential participants will be screened for major inclusion/exclusion criteria including age, alcohol/substance use, history of trauma and psychiatric/health/medication status. If potentially eligible, an Institutional Review Board (IRB) approved informed consent will be obtained and participants will be scheduled for a baseline assessment appointment. If an individual is ineligible to participate in this research protocol, she will continue in her usual community treatment program and/or if indicated, be referred for additional treatment services. The investigators decided to limit the study group to women because they represent the largest percentage of patients with comorbid PTSD and SUDs and most have experienced sexual and/or physical trauma. So when trauma-focused treatment is delivered in a group setting for this population, single sex groups create a safe, comfortable and open atmosphere that is required for MM-based treatment and trauma focused work. After having at least 7 days in standard treatment baseline assessments will be collected. Women meeting inclusion with no exclusionary criteria will be randomized to MBRP plus TAU or TAU alone control. Both groups will attend their standard intensive TAU program. The eight MBRP therapy sessions will be integrated into the standard TAU program and replace 8 TAU SS sessions. Participants will be introduced to the therapists and scheduled for their first individual/small group session.
The primary outcome measures for the efficacy portion of this study are 1) the effective reduction in PTSD symptom severity through the total score on the CAPS at the end of treatment between the two study groups and 2) the effective reduction in the proportion of days using and amount of use of alcohol/substances during the final 30 days of treatment as measured by the TLFB verified by urine drug screens (UDS). In addition, secondary endpoints will include CAPS scores at the 3 and 6 month post-intervention follow-up visits, the 7 day point prevalence abstinence rates at each treatment, post treatment and follow up visits. Also, PSS-SR, Obsessive Compulsive Drinking and Substance Use Scale-Revised (OCDS-R), Addiction Severity Index-Lite (ASI-Lite), Difficulties in Emotional Regulation Scale (DERS), Mindfulness Acceptance and Awareness Questionnaire (MAAS), Five Facet Mindfulness Questionnaire (FFQS) and Cognitive and Affective Regulation Scale (CAMS-R). There will also be secondary endpoints and used to gain insight into potential effect modification and mediation. Secondary analysis will also include the proportion of days using alcohol/drugs, craving, psychosocial functioning and emotional regulation. Participants will be assessed weekly throughout the intervention, at the end of the intervention and at 3- and 6- month follow-ups.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women receiving MBRP plus TAU | Experimental | Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). |
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| Women receiving TAU | No Intervention | Women will only receive treatment as usual (TAU less trauma focused group). |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP) | Behavioral | MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 | The Clinician-Administered Post Traumatic Stress Disorder Scale fifth edition (CAPS-5) is a 20 item structured interview that assesses the frequency and severity of Post Traumatic Stress Disorder (PTSD) symptoms on a scale of 0 (absent) to 4 (extreme/incapacitating). Scores are summed for a total score and higher scores represent higher symptom severity. Score range is 0-80. | 8 weeks (60 days baseline to end of treatment). Missing scores were imputed. Scores presented are controlled for baseline scores. |
| Measure | Description | Time Frame |
|---|---|---|
| Clinician Administered Posttraumatic Stress Disorder Scale-5 (CAPS-5) | The Clinician-Administered Post Traumatic Stress Disorder Scale fifth edition (CAPS-5) is a 20 item structured interview that assesses the frequency and severity of Post Traumatic Stress Disorder (PTSD) symptoms on a scale of 0 (absent) to 4 (extreme/incapacitating). Scores are summed for a total score and higher scores represent higher symptom severity. Score range is 0-80. Group differences in PTSD symptom severity are reported here. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Therese K Killeen, PhD APRN | Medical University of South Carolina | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Charleston Center | Charleston | South Carolina | 29401 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36705433 | Derived | Killeen TK, Wen CC, Neelon B, Baker N. Predictors of Treatment Completion among Women Receiving Integrated Treatment for Comorbid Posttraumatic Stress and Substance Use Disorders. Subst Use Misuse. 2023;58(4):500-511. doi: 10.1080/10826084.2023.2170183. Epub 2023 Jan 27. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Women Receiving MBRP Plus TAU | Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). Mindfulness Based Relapse Prevention (MBRP): MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. |
| FG001 | Women Receiving TAU | Women will only receive treatment as usual (TAU less trauma focused group). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
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| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Women Receiving MBRP Plus TAU | Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). Mindfulness Based Relapse Prevention (MBRP): MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. |
| 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 | Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5 | The Clinician-Administered Post Traumatic Stress Disorder Scale fifth edition (CAPS-5) is a 20 item structured interview that assesses the frequency and severity of Post Traumatic Stress Disorder (PTSD) symptoms on a scale of 0 (absent) to 4 (extreme/incapacitating). Scores are summed for a total score and higher scores represent higher symptom severity. Score range is 0-80. | Mean scale scores for participants at the end of treatment (baseline to end of treatment). | Posted | Mean | Standard Error | score on a scale | 8 weeks (60 days baseline to end of treatment). Missing scores were imputed. Scores presented are controlled for baseline scores. |
|
Approximately 8-9 months
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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 | Women Receiving MBRP Plus TAU | Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). Mindfulness Based Relapse Prevention (MBRP): MBRP integrates coping skills from cognitive-behavioral relapse prevention therapy with Mindfulness Meditation (MM) practices, raising awareness of substance use triggers and reactive behavioral patterns, and teaching skillful coping responses. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Suicidal ideation | Psychiatric disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anxiety | Psychiatric disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Therese K Killeen PhD, Principal Investigator | Medical University of South Carolina | 843-792-5232 | killeent@musc.edu |
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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 | Jan 11, 2021 | Sep 13, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
| D064419 | Chemically-Induced Disorders |
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| 3 (90 days from end of treatment to 3 month follow-up) and 6 (90 days from 3 month follow-up to 6 month follow-up) month follow-up. Missing scores are imputed. Scores presented are controlled for baseline scores. |
| Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) | Post Traumatic Symptom Severity Self Report (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of Post Traumatic Stress Disorder. Three questions representing the three new Diagnostic and Statistical Manual 5 (DSM5) criteria for Post Traumatic Stress Disorder were added. Each of the 20 items describe Post Traumatic Stress Disorder symptoms which participants rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Higher scores represent greater symptom severity and worsening of symptoms. The range of scores is 0 - 60. | weekly during treatment, end of treatment 8 weeks, 3 and 6 month follow-up. Missing scores were imputed at different time periods. Scores presented are controlled for baseline scores. |
| Time Line Follow Back (TLFB) | The Time Line Follow Back (TLFB) is a calendar based interview method to prompt recall of frequency of drinking alcohol and/or using substances over a given time period. Participants are asked to report any days in which they used alcohol and/or other substances (cannabis, stimulants,opioids, cocaine, sedatives) during a given time period. The mean percent of days reporting use of alcohol (Percent Days Drinking:PDD) and/or substances ( Percent Days Using Substances:PDU) for those individuals who attended the end of study visit (n=60) and reported any use during treatment is reported here. The time period includes the 8 weeks from baseline to end of the treatment intervention. | 8 weeks (60 days from baseline to end of treatment). |
| Time Line Follow Back (TLFB) | The Time Line Follow Back (TLFB) is an interview using a calendar based method to prompt recall for frequency of alcohol and substance (cannabis, stimulants, opioids, cocaine and sedatives) use over a given time period. Participants are asked to report any days in which they used alcohol and/or other substances (cannabis, stimulants,opioids, cocaine, sedatives) during a given time period. The mean percent of days reporting use of alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended the 3 month follow-up visit (n=53) and reported use of any alcohol and substances at the 3 month follow-up visit is reported here. | 3 month follow-up mean percent days using alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended (n=53) and reported any use at the 3 month follow-up (90 days from 3 to 6 month) visit. |
| Time Line Follow Back (TLFB) | The Time Line Follow Back (TLFB) is an interview using a calendar based method to prompt recall for obtaining frequency of alcohol and/or substance (cannabis, stimulants, opioids, cocaine and sedatives) use over a given time period. Participants are asked to report any days in which they used alcohol and/or other substances (cannabis, stimulants,opioids, cocaine, sedatives) during a given time period. The mean percent of days reporting use of alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended the 6 month follow-up visit (n=52) and reported any use of alcohol and/or substances at the 6 month follow-up visit is reported here. | 6 month follow-up mean percent days using alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended (n=52) and reported any use at the 6 month follow-up (90 days from 3 to 6 month follow-up) visit. |
| Time Line Follow Back (TLFB) | Time Line Follow Back (TLFB) is a calendar based method that allows a clinician to get a quantitative amount of an individual's daily drinking during a given period of time. Participants are asked about the number of drinks they consumed on the days that they drank. The mean number of standard alcohol drinks per drinking day (DDD) for those individuals who reported any drinking days during treatment from baseline to end of treatment (n=26) is reported. | 8 weeks (60 days from baseline to end of treatment). Only those participants who reported any drinking at the are included (n=26). Those who did not report any alcohol use are not represented/reported here. |
| Time Line Follow Back (TLFB) | Time Line Follow Back (TLFB) is a calendar based method that allows a clinician to obtain a quantitative amount of an individual's daily drinking during a given period of time. Participants are asked about the number of drinks they consumed on the days that they drank.The mean number of standard alcohol drinks per drinking day (DDD) for those individuals who reported any drinking from the end of treatment to the 3 month follow-up visit (n=18) is reported. | 3 month follow-up (90 days from end of treatment to 3 month follow-up). Only those participants who reported any drinking at the 3 month follow-up visit (n=18) are included. |
| Time Line Follow Back (TLFB) | Time Line Follow Back (TLFB) is a calendar based method that allows a clinician to obtain a quantitative amount of an individual's daily drinking during a given period of time. Participants are asked about the number of drinks they consumed on the days that they drank. The mean number of standard alcohol drinks per drinking day (DDD) for those participants who attended the 6 month follow-up visit who reported any drinking from the 3 month follow-up to the 6 month follow-up visit (n=20) is reported. | 6 month follow-up (90 days from the 3 month follow-up to the 6 month follow-up). Only those participants who reported any drinking at the 6 month follow-up visit are included (n=20). |
| Five Factor Mindfulness Questionnaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score ranging from 0-120. Higher scores represent higher levels of mindfulness. Total scores for participants who attended the 8 week end of study visit (N=60) are reported here. | 8 week end of treatment visit (60 days baseline to end of treatment) |
| Five Factor Mindfulness Questionnaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score ranging from 0-120. Higher scores represent higher levels of mindfulness. Total scores for participants who attended the 3 month follow-up visit (n=53) are reported here. | 3 month follow-up (90 days from end of treatment to 3 month follow-up visit) |
| Five Factor Mindfulness Questionnaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score ranging from 0-120. Higher scores represent higher levels of mindfulness. Total scores for participants who attended the 6 month follow-up visit (n=52) are reported here. | 6 month follow-up (90 days from 3 month follow-up visit to 6 month follow-up visit) |
| Difficulty in Emotion Regulation Scale (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Total scores for participants who attended the 8 week end of study visit (N=60) are reported here. | 8 week end of treatment (60 days baseline to end of treatment) |
| Difficulty in Emotional Regulation Scale (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Total scores for participants who attended the 3 month visit (N=53) are reported here. | 3 month follow-up (90 days end of treatment to 3 month follow-up) |
| Difficulty in Emotional Regulation Scale (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Total scores for participants who attended the 6 month visit (N=52) are reported here. | 6 month follow up (90 days from 3 month follow-up to 6 month follow-up) |
| Physician Decision |
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| Pregnancy |
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| Withdrawal by Subject |
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| BG001 | Women Receiving TAU | Women will only receive treatment as usual (TAU less trauma focused group). |
| 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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| Region of Enrollment | Number | participants |
|
| Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5) | The Clinician-Administered Post Traumatic Stress Disorder Scale (CAPS-5) is a 20 item structured interview that assesses the frequency and severity of Post Traumatic Stress Disorder (PTSD) symptoms on a scale of 0 (absent) to 4 (extreme/incapacitating). Participants are asked to rate the frequency and severity of the symptoms they are experiencing. Scores are summed for a total score and higher scores represent higher symptom severity. Score range is 0-80. Mean baseline total scores are reported here. | Mean | Standard Deviation | Scores on a scale |
|
| Post Traumatic Stress Symptom Severity Scale- Self Report | Post Traumatic Symptom Severity Self Report (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of Post Traumatic Stress Disorder. Three questions representing new Diagnostic and Statistical Manual 5 (DSM5) criteria for Post Traumatic Stress Disorder were added. The 20 items describe symptom frequency and severity on a scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Higher scores represent greater symptom severity and worsening of symptoms. The range of scores is 0 - 60. Mean baseline total scores are reported here. | Mean | Standard Deviation | Scores on a scale |
|
| Time Line Follow Back | The Time Line Follow Back (TLFB) is an interview using a calendar method to prompt recall of any use of alcohol and/or other substances including cannabis, stimulants, opioids, cocaine and sedatives over a given period of time. Participants are asked to recall the number of days they used alcohol and/or other substances such that the percent days using over a given period of time can be calculated. The baseline time period represents 60 days prior to enrollment. | Count of Participants | Participants |
|
| Time Line Follow Back | The Time Line Follow Back (TLFB) is an interview using a calendar method to prompt recall of frequency of alcohol and/or other substance use including cannabis, stimulants, opioids, cocaine and sedatives over a given period of time. Participants are asked to recall the number of days they used alcohol and/or other substances such that the percent days using over a given period of time can be calculated.The time period for the baseline interview is 60 days prior to enrollment. | Mean | Standard Deviation | percentage of days |
|
| Difficulty in Emotional Regulation (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Mean baseline total scores are reported here. | Mean | Standard Deviation | Scores on a scale |
|
| Five Factor Mindfulnes Questionaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score. Higher scores represent higher levels of mindfulness. Mean baseline total scores are reported here. | Mean | Standard Deviation | Scores on a scale |
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| OG001 | Women Receiving TAU | Women will only receive treatment as usual (TAU less trauma focused group). |
|
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| Secondary | Clinician Administered Posttraumatic Stress Disorder Scale-5 (CAPS-5) | The Clinician-Administered Post Traumatic Stress Disorder Scale fifth edition (CAPS-5) is a 20 item structured interview that assesses the frequency and severity of Post Traumatic Stress Disorder (PTSD) symptoms on a scale of 0 (absent) to 4 (extreme/incapacitating). Scores are summed for a total score and higher scores represent higher symptom severity. Score range is 0-80. Group differences in PTSD symptom severity are reported here. | Mean scores for participants at 3 and 6 month follow-up visits. Missing data scores were imputed. Scores presented are controlled for baseline scores. | Posted | Mean | Standard Error | score on a scale | 3 (90 days from end of treatment to 3 month follow-up) and 6 (90 days from 3 month follow-up to 6 month follow-up) month follow-up. Missing scores are imputed. Scores presented are controlled for baseline scores. |
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| Secondary | Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) | Post Traumatic Symptom Severity Self Report (PSS-SR) is a 17-item self-reported questionnaire to assess symptoms of Post Traumatic Stress Disorder. Three questions representing the three new Diagnostic and Statistical Manual 5 (DSM5) criteria for Post Traumatic Stress Disorder were added. Each of the 20 items describe Post Traumatic Stress Disorder symptoms which participants rate in terms of their frequency or severity using a Likert-type scale ranging from 0 (not at all or only one time) to 3 (almost always or five or more times per week). Higher scores represent greater symptom severity and worsening of symptoms. The range of scores is 0 - 60. | Mean total Post Traumatic Symptom Severity Self Report (PSS-SR) scores for participants throughout the study period. Missing scores were imputed at different time periods. Scores presented are controlled for baseline scores. | Posted | Mean | Standard Error | score on a scale | weekly during treatment, end of treatment 8 weeks, 3 and 6 month follow-up. Missing scores were imputed at different time periods. Scores presented are controlled for baseline scores. |
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| Secondary | Time Line Follow Back (TLFB) | The Time Line Follow Back (TLFB) is a calendar based interview method to prompt recall of frequency of drinking alcohol and/or using substances over a given time period. Participants are asked to report any days in which they used alcohol and/or other substances (cannabis, stimulants,opioids, cocaine, sedatives) during a given time period. The mean percent of days reporting use of alcohol (Percent Days Drinking:PDD) and/or substances ( Percent Days Using Substances:PDU) for those individuals who attended the end of study visit (n=60) and reported any use during treatment is reported here. The time period includes the 8 weeks from baseline to end of the treatment intervention. | The mean percent days reporting use of alcohol and/or other substances (cannabis, stimulants, opioids, cocaine and sedatives) for those individuals who attended the end of treatment study visit (n=60) and reported any use during treatment. Those individuals who did not use alcohol or substances during treatment are not reported here. Different number of participants reported use of various different substances during treatment. | Posted | Mean | Standard Deviation | percent of days | 8 weeks (60 days from baseline to end of treatment). |
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| Secondary | Time Line Follow Back (TLFB) | The Time Line Follow Back (TLFB) is an interview using a calendar based method to prompt recall for frequency of alcohol and substance (cannabis, stimulants, opioids, cocaine and sedatives) use over a given time period. Participants are asked to report any days in which they used alcohol and/or other substances (cannabis, stimulants,opioids, cocaine, sedatives) during a given time period. The mean percent of days reporting use of alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended the 3 month follow-up visit (n=53) and reported use of any alcohol and substances at the 3 month follow-up visit is reported here. | Mean of percent days reporting use of alcohol and/or substances (cannabis, stimulants, opioids, cocaine and sedative) for those participants who attended the 3 month follow-up visit (n=53) and reported any alcohol and/or substance use at the 3 month follow-up visit. Those participants who did not report any alcohol and/or substance use are not represented here. Different number of participants reported use of various different substances at the 3 month follow-up visit. | Posted | Mean | Standard Deviation | percent of days | 3 month follow-up mean percent days using alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended (n=53) and reported any use at the 3 month follow-up (90 days from 3 to 6 month) visit. |
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| Secondary | Time Line Follow Back (TLFB) | The Time Line Follow Back (TLFB) is an interview using a calendar based method to prompt recall for obtaining frequency of alcohol and/or substance (cannabis, stimulants, opioids, cocaine and sedatives) use over a given time period. Participants are asked to report any days in which they used alcohol and/or other substances (cannabis, stimulants,opioids, cocaine, sedatives) during a given time period. The mean percent of days reporting use of alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended the 6 month follow-up visit (n=52) and reported any use of alcohol and/or substances at the 6 month follow-up visit is reported here. | Mean percent days of use for participants attending (n=52) the 6 month follow-up visit and who reported use of alcohol and/or substances (cannabis, stimulants, opioids, cocaine and sedatives) at the 6 month follow-up visit. Individuals who did not report use of any alcohol and/or substances are not reported/represented here. Different number of participants reported use of various different substances at the 6 month follow-up visit. | Posted | Mean | Standard Deviation | percent of days | 6 month follow-up mean percent days using alcohol (PDD) and/or substances (PDU: cannabis, stimulants, opioids, cocaine and sedatives) for those who attended (n=52) and reported any use at the 6 month follow-up (90 days from 3 to 6 month follow-up) visit. |
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| Secondary | Time Line Follow Back (TLFB) | Time Line Follow Back (TLFB) is a calendar based method that allows a clinician to get a quantitative amount of an individual's daily drinking during a given period of time. Participants are asked about the number of drinks they consumed on the days that they drank. The mean number of standard alcohol drinks per drinking day (DDD) for those individuals who reported any drinking days during treatment from baseline to end of treatment (n=26) is reported. | Number of drinks per drinking day for participants who attended the 8 week end of study visit and used alcohol during the 8 weeks of treatment (n=26). Those individuals who did not report alcohol use are not reported here. | Posted | Mean | Standard Deviation | drinks per drinking day | 8 weeks (60 days from baseline to end of treatment). Only those participants who reported any drinking at the are included (n=26). Those who did not report any alcohol use are not represented/reported here. |
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| Secondary | Time Line Follow Back (TLFB) | Time Line Follow Back (TLFB) is a calendar based method that allows a clinician to obtain a quantitative amount of an individual's daily drinking during a given period of time. Participants are asked about the number of drinks they consumed on the days that they drank.The mean number of standard alcohol drinks per drinking day (DDD) for those individuals who reported any drinking from the end of treatment to the 3 month follow-up visit (n=18) is reported. | 3 months follow-up mean drinks per drinking day for those participants who reported any use of alcohol at the 3 month follow-up (90 days from end of treatment; n=18) visit. Participants who did not report any alcohol use are not reported here. | Posted | Mean | Standard Deviation | drinks per drinking day | 3 month follow-up (90 days from end of treatment to 3 month follow-up). Only those participants who reported any drinking at the 3 month follow-up visit (n=18) are included. |
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| Secondary | Time Line Follow Back (TLFB) | Time Line Follow Back (TLFB) is a calendar based method that allows a clinician to obtain a quantitative amount of an individual's daily drinking during a given period of time. Participants are asked about the number of drinks they consumed on the days that they drank. The mean number of standard alcohol drinks per drinking day (DDD) for those participants who attended the 6 month follow-up visit who reported any drinking from the 3 month follow-up to the 6 month follow-up visit (n=20) is reported. | Participants who reported any drinking at the 6 month follow-up visit (90 days from 3 month to 6 month follow-up visit: n=20). Those who reported no drinking are not included here. | Posted | Mean | Standard Deviation | drinks per drinking day | 6 month follow-up (90 days from the 3 month follow-up to the 6 month follow-up). Only those participants who reported any drinking at the 6 month follow-up visit are included (n=20). |
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| Secondary | Five Factor Mindfulness Questionnaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score ranging from 0-120. Higher scores represent higher levels of mindfulness. Total scores for participants who attended the 8 week end of study visit (N=60) are reported here. | Participants who attended the 8 week end of study visit (N=60) are reported/represented here. Not all participants attended end of treatment study visits. | Posted | Mean | Standard Error | score on a scale | 8 week end of treatment visit (60 days baseline to end of treatment) |
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| Secondary | Five Factor Mindfulness Questionnaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score ranging from 0-120. Higher scores represent higher levels of mindfulness. Total scores for participants who attended the 3 month follow-up visit (n=53) are reported here. | Participants who attended the 3 month follow-up visit (N=53) are reported/represented here. Not all participants attended all study visits. | Posted | Mean | Standard Error | score on a scale | 3 month follow-up (90 days from end of treatment to 3 month follow-up visit) |
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| Secondary | Five Factor Mindfulness Questionnaire (FFMQ) | The Five Factor Mindfulness Questionnaire (FFMQ) is a 24 item self report scale that measures the trait-like tendency to be mindful in daily life. It is comprised of aspects of mindfulness such as observing, describing, acting with awareness, non-judging, and non-reactivity. Item ratings range from 1 (never or very rarely true) to 5 (very often true or always true) and items are summed for a total score ranging from 0-120. Higher scores represent higher levels of mindfulness. Total scores for participants who attended the 6 month follow-up visit (n=52) are reported here. | Participants who attended the 6 month follow-up visit (N=52) are reported/represented here. Not all participants attended all study visits. | Posted | Mean | Standard Error | score on a scale | 6 month follow-up (90 days from 3 month follow-up visit to 6 month follow-up visit) |
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| Secondary | Difficulty in Emotion Regulation Scale (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Total scores for participants who attended the 8 week end of study visit (N=60) are reported here. | Participants who attended the 8 week end of study visit (N=60) are reported/represented here. Not all participants attended all study visits. | Posted | Mean | Standard Error | score on a scale | 8 week end of treatment (60 days baseline to end of treatment) |
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| Secondary | Difficulty in Emotional Regulation Scale (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Total scores for participants who attended the 3 month visit (N=53) are reported here. | Participants who attended the 3 month follow-up visit (N=53) are reported/represented here. Not all participants attended all study visits. | Posted | Mean | Standard Error | score on a scale | 3 month follow-up (90 days end of treatment to 3 month follow-up) |
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| Secondary | Difficulty in Emotional Regulation Scale (DERS) | The Difficulty in Emotion Regulation Scale (DERS) is a 36-item self-report measure developed to assess clinically significant difficulties in emotion regulation. Responses range from 1 (almost never) to 5 (almost always) with higher scores indicating greater difficulties in emotion regulation. The range of scores is 0 to 180 and item scores are summed for a total score. Total scores for participants who attended the 6 month visit (N=52) are reported here. | Participants who attended the 6 month follow-up visit (N=52) are reported/represented here. Not all participants attended all study visits. | Posted | Mean | Standard Error | score on a scale | 6 month follow up (90 days from 3 month follow-up to 6 month follow-up) |
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| 0 |
| 45 |
| 4 |
| 45 |
| 28 |
| 45 |
| EG001 | Women Receiving TAU | Women will only receive treatment as usual (TAU less trauma focused group). | 1 | 45 | 3 | 45 | 20 | 45 |
| Knee Infection | Infections and infestations | Systematic Assessment |
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| alcohol poisening | Injury, poisoning and procedural complications | Systematic Assessment |
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| Physical Assault | Injury, poisoning and procedural complications | Systematic Assessment | concussion, rib contusion, bruising, abrasions - overnight hospitalization |
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| gall bladder stones | Hepatobiliary disorders | Systematic Assessment | Participant had a cholecystectomy |
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| Severe opioid withdrawal | Psychiatric disorders | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Bronchitis | Infections and infestations | Systematic Assessment |
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| Cold | Infections and infestations | Systematic Assessment |
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| Depressed mood | Psychiatric disorders | Systematic Assessment |
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| Flu | Infections and infestations | Systematic Assessment |
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| Headache | Nervous system disorders | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Stomach pain | Gastrointestinal disorders | Systematic Assessment |
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| Teeth Decay | Infections and infestations | Systematic Assessment |
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Not provided
Not provided
| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 8 |
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| 3 month follow-up |
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| 6 month follow-up |
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| PDU cannabis 8 weeks |
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| PDU stimulants 8 weeks |
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| PDU opioids 8 weeks |
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| PDU cocaine 8 weeks |
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| PDU sedatives 8 weeks |
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| PDU cannabis 3 month follow-up |
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| PDU stimulants 3 month follow-up |
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| PDU opioids 3 month follow-up |
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| PDU cocaine 3 month follow-up |
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| PDU sedatives 3 month follow-up |
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| PDU cannabis 6 month follow-up |
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| PDU stimulant 6 month follow-up |
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| PDU opioids 6 month follow-up |
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| PDU cocaine 6 month follow-up |
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| PDU sedatives 6 month follow-up |
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