Women's Treatment and Early Recovery
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 8/22/2018 |
| Start Date: | October 15, 2015 |
| End Date: | June 30, 2019 |
Neural Mechanisms in Women's Treatment and Early Recovery
Approximately 25 million Americans struggle with alcohol or drug problems annually. Abuse of
alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related
to crime, lost work productivity and health care. While effective treatments exist, over half
of those who enter treatment for substance use disorders drop out early in treatment and
return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis
of substance use disorder (SUD) and relapse risk. Low-income women report high levels of
stress in SUD residential treatment stemming from significant economic and family stressors
in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,
especially in early stages of residential treatment, is a major concern because it can
increase dropout. Dropout from residential treatment places women at risk of substance use
relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions
with racially/ethnically diverse low-income women with SUDs, especially regarding the
efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout
and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,
Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women
(MBRP-W), that supports the needs of women in residential treatment. This MBI integrates
relapse prevention, addresses literacy level, and is relevant to issues surrounding
treatment- and relapse-related stressors of disadvantaged women. The current project has
three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention
and substance use relapse in racially/ethnically diverse low-income women; (2) to determine
the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes
associated with program effects. A rationale for MBRP-W is the need for self-initiated stress
management skills in women with SUDs during the early stressful periods of residential
treatment that increase risk of dropout and relapse.
alcohol and drugs is costly to our nation, exacting more than $428 billion in costs related
to crime, lost work productivity and health care. While effective treatments exist, over half
of those who enter treatment for substance use disorders drop out early in treatment and
return to alcohol or drug abuse. Psychological stress is a causal factor in the pathogenesis
of substance use disorder (SUD) and relapse risk. Low-income women report high levels of
stress in SUD residential treatment stemming from significant economic and family stressors
in addition to challenges of adjusting to residential treatment demands. Unmanaged stress,
especially in early stages of residential treatment, is a major concern because it can
increase dropout. Dropout from residential treatment places women at risk of substance use
relapse. A gap in knowledge persists regarding the use of mindfulness-based interventions
with racially/ethnically diverse low-income women with SUDs, especially regarding the
efficacy of adapted (Mindfulness-based interventions) MBIs for preventing residential dropout
and decreasing relapse. We have fully adapted, developed, and pilot tested a novel MBI,
Moment-by-Moment in Women's Recovery: Mindfulness Based Relapse Prevention for Women
(MBRP-W), that supports the needs of women in residential treatment. This MBI integrates
relapse prevention, addresses literacy level, and is relevant to issues surrounding
treatment- and relapse-related stressors of disadvantaged women. The current project has
three specific aims: (1) to test the efficacy of MBRP-W on residential treatment retention
and substance use relapse in racially/ethnically diverse low-income women; (2) to determine
the mechanisms of change underlying the MBRP-W program; and (3) to explore neural changes
associated with program effects. A rationale for MBRP-W is the need for self-initiated stress
management skills in women with SUDs during the early stressful periods of residential
treatment that increase risk of dropout and relapse.
- 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.
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.
Inclusion criteria for parent study:
- Female
- Adult in California (18 years or older)
- Diagnosed with a substance use disorder (SUD)
- Speaks fluent English
- Client at study site, substance use disorder residential facility at time of
recruitment
Exclusion criteria for parent study:
- Inability to comprehend informed consent
- Unwilling to sign informed consent
- Cognitive impairment, psychotic disorder or severe chronic mental health condition
based on clinical intake DSM-V assessment
- Older than 65 years of age
- Reported suicidality in last 30 days
- Current prisoner
- Pregnant in the 3rd trimester
- Pregnant (MRI subsample only)
- Not willing to be audio recorded
- Not willing to have data stored for research purposes
Additional exclusion criteria for brain imaging sub-study:
- Older than 50 years of age
- Not in good general health
- Left handed (with a mean item score >1 on the handedness scale)
- Currently pregnant
- Current medical devices (cardiac pacemaker, implanted cardiac defibrillator, carotid
artery vascular clamp, neurostimulator, cochlear implant, metal fragments (including
shrapnel) in the head, eyes, or skin, vascular stent, ocular implant, penile implant,
vascular filter for clots (including Greenfield, Umbrella, or Birds Nest filters)
- Other non-removable devices (IUD, dental braces or retainer, piercings that cannot be
removed prior to resting, permanent eye-liner)
- Body Mass Index (BMI) greater than 36
- History of head trauma resulting in loss of consciousness for more than 5 minutes
- Documented or subjectively reported claustrophobia
- Having hair extensions or a wig connected by wire
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