Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD

Study Overview
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Brief Summary
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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.

Detailed Description
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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: PTSD symptom severity as measured by the Clinician's Administered PTSD Scale (CAPS) and Post Traumatic Stress Disorder Symptom Scale-Self Report (PSS-SR); Alcohol and substance use as measured by the Timeline Follow Back (TLFB) assessment and corroborated with urine drug screens. psychosocial functioning; Measure of emotional regulation and mindfulness awareness, attention and acceptance. 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.

Official Title
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Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD

Conditions
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Stress Disorders, Post-Traumatic, Substance-Related Disorders

Intervention / Treatment
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* Behavioral: Mindfulness Based Relapse Prevention (MBRP)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women between 18 and 65 years of age enrolled in the Charleston Center (CC) intensive outpatient and New Life program treatment. Able to comprehend English. Meets fifth edition Diagnostic and Statistical Manual V (DSM V) criteria for current alcohol or substance use disorder and have used alcohol/substances in the 30 days prior to clinic treatment entry. Meets DSM V criteria for current PTSD with a score greater than or equal to 25 on the CAPS 5.0. Participants may also meet criteria for a mood or anxiety disorder. Participants on psychotropic medications for a mood or anxiety disorder must have been stabilized on medications for at least 4 weeks before therapy initiation. Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. Willing to commit to 8 therapy sessions, baseline, weekly and follow-up assessments. Exclusion Criteria: Current primary psychotic or thought disorder (i.e. Schizophrenia or schizoaffective disorder, mania), major depression with suicidal ideation, dissociative identity disorder and/or homicidal ideations. Present a serious suicide risk, such as those with severe depression, or who are likely to require hospitalization during the course of the study. In ongoing therapy for PTSD either within or outside of the CC, who are not willing to discontinue these therapies for the duration of the study therapy, Unstable medical condition or one that may require hospitalization during the course of the study. Women who are pregnant or planning to become pregnant.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Women receiving MBRP plus TAU<br>Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). | Behavioral: Mindfulness Based Relapse Prevention (MBRP)<br>* 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.<br>|
| No Intervention: Women receiving TAU<br>Women will only receive treatment as usual (TAU less trauma focused group). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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. | 

Secondary Outcome Measures

| Outcome Measure | 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. | 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Mindfulness, Comorbid PTSD and SUD, Meditation