Trial Outcomes & Findings for Women's Treatment and Early Recovery (NCT NCT02977988)
NCT ID: NCT02977988
Last Updated: 2026-01-13
Results Overview
Number of women being designated by the site clinic as a completer during a discharge event.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
200 participants
Primary outcome timeframe
5 month follow period
Results posted on
2026-01-13
Participant Flow
Participants were adult women clinically diagnosed with SUD and admitted to residential SUD treatment. Recruitment spanned 2015-2018. All patients met one-on-one with the site's intake clinician coordinator. The site psychiatrist and on-site clinician coordinator discussed diagnostic assessment, determined final diagnoses, and made record in the patient chart. The site intake counselor verified study eligibility, and for those women who were eligible, informed clients about our study.
Of 367 potential participants who were screened for the study at the residential site, 200 were eligible and randomized to study conditions and attended the first treatment sessions. Those who missed the first study class session (class overview and introduction) were excluded from the study by design leaving N = 200 enrolled in the trial, 100 per condition.
Participant milestones
| Measure |
Mindfulness Meditation [100 Enrolled]
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
|
Active Comparator [100 Enrolled]
Brain and Recovery (B\&R)
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.
|
|---|---|---|
|
Overall Study
STARTED
|
100
|
100
|
|
Overall Study
COMPLETED
|
87
|
93
|
|
Overall Study
NOT COMPLETED
|
13
|
7
|
Reasons for withdrawal
| Measure |
Mindfulness Meditation [100 Enrolled]
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
|
Active Comparator [100 Enrolled]
Brain and Recovery (B\&R)
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
7
|
Baseline Characteristics
Women's Treatment and Early Recovery
Baseline characteristics by cohort
| Measure |
Mindfulness Meditation [100 Enrolled]
n=100 Participants
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
|
Active Comparator [100 Enrolled]
n=100 Participants
Brain and Recovery (B\&R)
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.
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.4 years
STANDARD_DEVIATION 9.8 • n=210 Participants
|
32.6 years
STANDARD_DEVIATION 8.4 • n=19 Participants
|
32.5 years
STANDARD_DEVIATION 9.1 • n=123 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=210 Participants
|
100 Participants
n=19 Participants
|
200 Participants
n=123 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=210 Participants
|
0 Participants
n=19 Participants
|
0 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
56 Participants
n=210 Participants
|
60 Participants
n=19 Participants
|
116 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
43 Participants
n=210 Participants
|
38 Participants
n=19 Participants
|
81 Participants
n=123 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=210 Participants
|
2 Participants
n=19 Participants
|
3 Participants
n=123 Participants
|
|
Region of Enrollment
United States
|
100 participants
n=210 Participants
|
100 participants
n=19 Participants
|
200 participants
n=123 Participants
|
|
SUD diagnosis DSM5
Alcohol use disorder
|
10 participants
n=210 Participants
|
9 participants
n=19 Participants
|
19 participants
n=123 Participants
|
|
SUD diagnosis DSM5
Drug use disorder
|
71 participants
n=210 Participants
|
74 participants
n=19 Participants
|
145 participants
n=123 Participants
|
|
SUD diagnosis DSM5
Both disorders
|
18 participants
n=210 Participants
|
14 participants
n=19 Participants
|
32 participants
n=123 Participants
|
|
SUD diagnosis DSM5
Missing
|
1 participants
n=210 Participants
|
3 participants
n=19 Participants
|
4 participants
n=123 Participants
|
PRIMARY outcome
Timeframe: 5 month follow periodPopulation: Women with SUD at a residential treatment site
Number of women being designated by the site clinic as a completer during a discharge event.
Outcome measures
| Measure |
Mindfulness Meditation
n=100 Participants
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
|
Active Comparator
n=100 Participants
Brain and Recovery (B\&R)
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.
|
|---|---|---|
|
Treatment Completion
|
43 Number of women
|
31 Number of women
|
PRIMARY outcome
Timeframe: 8.5 monthsPopulation: Women with SUD enrolled in a residential treatment program who remained in the study and completed follow-up assessments approximately 8.5 months after the start of the intervention.
Days of any drug use to include multiple drug types from study intervention end date to follow-up
Outcome measures
| Measure |
Mindfulness Meditation
n=88 Participants
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
|
Active Comparator
n=93 Participants
Brain and Recovery (B\&R)
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 of Any Drug Use
|
16.92 days
Standard Deviation 32.81
|
24.97 days
Standard Deviation 51.65
|
SECONDARY outcome
Timeframe: 8.5 monthsPopulation: Women with SUD
Five Facet Mindfulness Questionnaire (FFMQ): higher scores indicate better mindfulness qualities (better outcome). Perceived Stress Scale (PSS): higher scores indicate greater perceived stress (worse outcome). Depression Anxiety Stress Scale (DASS): higher scores indicate greater depression, anxiety, and stress (worse outcome). Distress Tolerance Scale (DTS): higher scores indicate greater distress tolerance (better outcome). Difficulties in Emotion Regulation Scale (DERS): higher scores indicate greater difficulties in emotion regulation (worse outcome). Penn Craving Scale (PCS): higher scores indicate greater craving (worse outcome). Positive and Negative Affect Schedule (PANAS) - Negative Affect subscale: higher scores indicate greater negative affect (worse outcome). Minimum and maximum values are not standardized.
Outcome measures
| Measure |
Mindfulness Meditation
n=100 Participants
Mindfulness-Based Relapse Prevention-Women (MBRP-W)
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.
|
Active Comparator
n=100 Participants
Brain and Recovery (B\&R)
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.
|
|---|---|---|
|
Psychological Symptoms
Depression Anxiety Stress Scale (high worse; range 0-63)
|
9 score on a non-standardized scale
Standard Deviation .6
|
9 score on a non-standardized scale
Standard Deviation .6
|
|
Psychological Symptoms
Distress Tolerance Scale (high better; range 1-5)
|
3.3 score on a non-standardized scale
Standard Deviation .1
|
3.2 score on a non-standardized scale
Standard Deviation .1
|
|
Psychological Symptoms
Difficulties in emotion regulation scale (high worse, range 7-126)
|
74 score on a non-standardized scale
Standard Deviation 2.4
|
74 score on a non-standardized scale
Standard Deviation 2.4
|
|
Psychological Symptoms
Negative Affect Subscale (high worse, range 10-50)
|
23 score on a non-standardized scale
Standard Deviation .8
|
23 score on a non-standardized scale
Standard Deviation .8
|
|
Psychological Symptoms
Five Facet Mindfulness Questionnaire (high better; range 5-195)
|
83 score on a non-standardized scale
Standard Deviation 1.3
|
85 score on a non-standardized scale
Standard Deviation 1.2
|
|
Psychological Symptoms
Perceived Stress Scale (high worse; range 0-40)
|
18 score on a non-standardized scale
Standard Deviation 0.7
|
17 score on a non-standardized scale
Standard Deviation .06
|
|
Psychological Symptoms
Penn Alcohol Craving Scale (high worse, range 1-7)
|
1.6 score on a non-standardized scale
Standard Deviation .2
|
1.4 score on a non-standardized scale
Standard Deviation .2
|
Adverse Events
Mindfulness Meditation [100 Enrolled in Trial] Women Not Attending First Session Were Not Enrolled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Active Comparator [100 Enrolled in Trial] Women Not Attending First Session Were Not Enrolled
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place