Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02755103|
Recruitment Status : Recruiting
First Posted : April 28, 2016
Last Update Posted : March 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Stress Disorders, Post-Traumatic Substance-Related Disorders||Behavioral: Mindfulness Based Relapse Prevention (MBRP)||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||80 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD|
|Actual Study Start Date :||June 1, 2016|
|Estimated Primary Completion Date :||September 30, 2020|
|Estimated Study Completion Date :||September 30, 2020|
Experimental: Women receiving MBRP plus TAU
Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group).
Behavioral: 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.
No Intervention: Women receiving TAU
Women will only receive treatment as usual (TAU less trauma focused group).
- Reduction in PTSD symptom severity. [ Time Frame: end of treatment at 8 weeks ]Effect size estimates of between group differences in PTSD symptom severity reduction as measured by the Clinician Administered PTSD Scale (CAPS)
- Reduction in frequency of alcohol/substances [ Time Frame: final 30 days at study completion ]Reduction in the proportion of days using alcohol/substances during the final 30 days of treatment, as measured by the Time Line Follow Back (TLFB)
- Reduction in amount of alcohol/substances used [ Time Frame: final 30 days at study completion ]Reduction in amount of alcohol/substances used during the final 30 days of treatment, as measured by the Time Line Follow Back (TLFB)
- Reduction in frequency of alcohol/substances [ Time Frame: 3 and 6 months follow-up ]Reduction in the proportion of days using alcohol/substances for the past 30 days at 3- and 6- month follow -up as measured by the Time Line Follow Back (TLFB) .
- Reduction in quantity of alcohol/substances [ Time Frame: 3 and 6 months follow-up ]Reduction in the amount of use of alcohol/substances for the past 30 days at 3- and 6- month follow -up as measured by the Time Line Follow Back (TLFB) .
- Reduction in PTSD symptom severity. [ Time Frame: 3 and 6 month follow-up ]Group differences in PTSD symptom severity reduction as measured using the Clinician Administered PTSD Scale (CAPS).
- Between group increase in emotional regulation [ Time Frame: weekly, 3- and 6- months ]Measures of emotional regulation to gain insight into potential effect modification and mediation of the intervention. Emotional regulation as measured by the Difficulties in Emotional Regulation Scale (DERS).
- Between group increase in mindfulness [ Time Frame: weekly, 3- and 6- months ]Measures of mindfulness to gain insight into potential effect modification and mediation of the intervention. Mindfulness as measured by the Mindfulness Acceptance and Awareness Scale (MAAS).
- PTSD symptom Severity [ Time Frame: weekly for 8 weeks during intervention ]Reduction in PTSD symptom severity as measured by the PTSD Symptom Severity Scale - Self Report (PSS-SR) at the end of treatment .
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02755103
|Contact: Hayley Feigl, MSemail@example.com|
|Contact: Mary Shaw, BSfirstname.lastname@example.org|
|United States, South Carolina|
|The Charleston Center||Recruiting|
|Charleston, South Carolina, United States, 29401|
|Contact: Chanda F Brown, PhD, LMSW 843-958-3472 CFBrown@charlestoncounty.org|
|Contact: Rebecca Whitt email@example.com|
|Principal Investigator: Therese K Killeen, PhD, APRN|
|Sub-Investigator: Chanda F Brown, PhD, LMSW|
|Sub-Investigator: Bowen Sarah, PhD|
|Sub-Investigator: Brady T Kathleen, MD PhD|
|Sub-Investigator: Hamner Mark, MD|
|Sub-Investigator: Baker Nate, MS|
|Principal Investigator:||Therese K Killeen, PhD APRN||Medical University of South Carolina|