Women's Treatment and Early Recovery (MBRP-W)
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|ClinicalTrials.gov Identifier: NCT02977988|
Recruitment Status : Recruiting
First Posted : November 30, 2016
Last Update Posted : November 30, 2016
|Condition or disease||Intervention/treatment|
|Substance-related Disorders||Behavioral: Mindfulness Meditation Behavioral: Brain and Recovery (B&R)|
- This randomized clinical trial will deliver two interventions as add-ons to residential substance use disorder (SUD) treatment: (1) Moment-by-Moment in women's Recovery: Mindfulness-Based Approach to Relapse Prevention (MBRP-W) and (2) Brain and Recovery (B&R) which serves as an active psychoeducational attention control group.
- Participants (N=165) who meet study eligibility criteria based on intake assessment will be recruited and complete baseline assessments during weeks 3-6 after entry into a residential treatment program. Participants will be randomly assigned to interventions using Urn randomization. All participants (MBRP-W and B&R) will receive SUD treatment as normally provided by the treatment program. Fifteen participants from each intervention group (N=30) will be selected to participate in a brain imaging (MRI and fMRI) substudy.
- Participants will be adult females who have been admitted to a residential treatment center in an urban area of California and who are diagnosed with a SUD based on clinical intake Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V) diagnostic assessment.
- MBRP-W is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations. Facilitators will have previous experience in MBSR facilitation and will be trained in MBRP-W. Each session has a central theme and is divided into five segments consisting of (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and practice assignments for the next class.
- B&R is delivered in 12 bi-weekly 80-minute group sessions with SUD clinical populations. Facilitators will be trained in B&R. The B&R group will receive didactic education on the neurobiology of addiction. B&R contains no information on behavior change, relapse prevention, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to that of the current study (i.e., racially/ethnically diverse and low-income women in SUD treatment) with input and review from focus group participants, care providers in SUD treatment, and three experts on the neurobiology of addiction. Topics include: (1) brain structure and function related to addiction, (2) effects of various types of substance use on the brain, and (3) rewarding effects of substance use and how these rewarding effects can lead to addiction.
- There are three data collection points, 1) baseline, 2) immediate post-intervention, and 3) 8-months post-intervention completion. Data will be collected in-person by research interviewers via computer-assisted interviews, which includes administration of an alcohol Breathalyzer test to assess alcohol use and collection of a urine sample to assess drug use. Interviews will be conducted at the treatment program (for those who remain in residential treatment) or at convenient locations for participants no longer in treatment. Baseline interview will occur prior to randomization, post-intervention interview will occur within 1-2 weeks of the last group session, and the follow-up interview will occur at an 8-months post-intervention completion window. Brain imaging for a subsample of participants will be completed at baseline and immediate post-intervention.
- Number of intervention program class sessions attended will be collected for all enrolled participants.
- Participant Satisfaction Surveys measuring acceptability, credibility, and perceived utility of the study arms will be administered to both groups at two class sessions.
- Applied Mindfulness Practice Scale (AMPS) measuring the participant's application of mindfulness skills to address life challenges, will be administered to the MBRP-W participants at four class sessions as well as at follow-up. Mindfulness practice effort will also be assessed at these same four class sessions.
- An in-treatment clinical record review of services will be collected weekly for the duration of residential treatment.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Neural Mechanisms in Women's Treatment and Early Recovery|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||April 2019|
|Estimated Study Completion Date :||May 2019|
Experimental: Mindfulness Meditation
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
Behavioral: Mindfulness Meditation
MBRP-W is delivered in 12 bi-weekly 80-minute group sessions. Facilitators with previous experience in MBSR and trained in MBRP-W will deliver each group. Each session has a central theme and is divided into five segments consisting of: (a) a welcome meditation or other mindfulness practice, (b) a review of session objectives, (c) a brief didactic psycho-educational presentation and discussion based on the session's theme, (d) experiential and formal meditation or other practices, and (e) readings and assignments for the next class. Participants are expected to learn skill building techniques to reducing stress using mindfulness-based principles to complement their recovery treatment program.
Other Name: Mindfulness-Based Relapse Prevention-Women (MBRP-W)
Active Comparator: Active Comparator
Brain and Recovery (B&R)
Behavioral: Brain and Recovery (B&R)
B&R is delivered in 12 bi-weekly 80-minute group sessions delivered by two trained interventionists. The B&R group will receive didactic education on the neurobiology of addiction. B&R contains no information on behavior change, stress reduction, or mindfulness-based or relapse-related content. The intervention was developed over three years with a population similar to those in the study and with input from patients and experts on neurobiology of addiction. Topics include: (1) brain structures and functions related to addiction, (2) effects of various types of substances on the brain, and (3) rewarding effects and how these lead to addiction. Participants are expected to gain knowledge pertaining to the effects of drugs on the brain.
- Days in residential treatment [ Time Frame: 11 month interval ]Days in residential treatment confirmed by residential clinic archival records
- Use of and relapse to alcohol and illicit drugs [ Time Frame: 11 month interval ]Use of and relapse to alcohol and illicit drug obtained from the interviewer-assisted timeline followback calendar and confirmed by urine drug screen and alcohol breathalyzer test
- Neural correlates [ Time Frame: 10 week interval ]Brain tissue morphology and neural network correlates of mindfulness training obtained from magnetic resonance imaging (MRI) and functional magnetic resonance imaging (fMRI) in subsample of n=15 in each treatment group at pre- and immediate post-intervention.
- Psychological mechanisms of action underlying intervention [ Time Frame: 11 month interval ]Self-report of mindfulness qualities, perceived stress, psychological distress, distress tolerance, self-regulation, craving, and negative affect
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02977988
|Contact: Hortensia Amaro, PhDfirstname.lastname@example.org|
|Contact: David S Black, PhD, MPHemail@example.com|
|United States, California|
|Prototypes' Pomona Women's Center||Recruiting|
|Pomona, California, United States, 91767|
|Contact: April Wilson, MSW, CATC IV 213-542-3845 firstname.lastname@example.org|
|Contact: Garett Staley, LCSW, MPA, (909) 624-1233 email@example.com|
|Principal Investigator:||Hortensia Amaro||University of Southern California School of Social Work|