Trial Outcomes & Findings for Mindfulness Meditation for the Treatment of Women With Comorbid PTSD and SUD (NCT NCT02755103)

Last Updated: 2023-01-03

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

90 participants

Primary outcome timeframe

8 weeks (60 days baseline to end of treatment). Missing scores were imputed. Scores presented are controlled for baseline scores.

Results posted on

2023-01-03

Participant Flow

Participant milestones

Participant milestones
Measure	Women Receiving MBRP Plus TAU Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU Women will only receive treatment as usual (TAU less trauma focused group).
Overall Study STARTED	45	45
Overall Study 8 Week Follow-up Completed	32	28
Overall Study 3 Month Follow-up Completed	26	27
Overall Study COMPLETED	25	27
Overall Study NOT COMPLETED	20	18

Reasons for withdrawal

Reasons for withdrawal
Measure	Women Receiving MBRP Plus TAU Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU Women will only receive treatment as usual (TAU less trauma focused group).
Overall Study Lost to Follow-up	17	15
Overall Study Death	0	1
Overall Study Physician Decision	0	1
Overall Study Pregnancy	0	1
Overall Study Withdrawal by Subject	3	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women Receiving MBRP Plus TAU n=45 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=45 Participants Women will only receive treatment as usual (TAU less trauma focused group).	Total n=90 Participants Total of all reporting groups
Age, Continuous	33.2 years STANDARD_DEVIATION 9.2 • n=5 Participants	32.1 years STANDARD_DEVIATION 6.1 • n=7 Participants	32.6 years STANDARD_DEVIATION 7.8 • n=5 Participants
Sex: Female, Male Female	45 Participants n=5 Participants	45 Participants n=7 Participants	90 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants	3 Participants n=7 Participants	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	42 Participants n=5 Participants	42 Participants n=7 Participants	84 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	13 Participants n=7 Participants	21 Participants n=5 Participants
Race (NIH/OMB) White	31 Participants n=5 Participants	26 Participants n=7 Participants	57 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	45 participants n=5 Participants	45 participants n=7 Participants	90 participants n=5 Participants
Clinician Administered Posttraumatic Stress Disorder Scale - 5 (CAPS-5)	42 Scores on a scale STANDARD_DEVIATION 10 • n=5 Participants	41 Scores on a scale STANDARD_DEVIATION 10.4 • n=7 Participants	41.5 Scores on a scale STANDARD_DEVIATION 10.1 • n=5 Participants
Post Traumatic Stress Symptom Severity Scale- Self Report	34.1 Scores on a scale STANDARD_DEVIATION 12.8 • n=5 Participants	32.8 Scores on a scale STANDARD_DEVIATION 12.9 • n=7 Participants	33.4 Scores on a scale STANDARD_DEVIATION 11.3 • n=5 Participants
Time Line Follow Back Any alcohol use	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Time Line Follow Back Any cannabis use	14 Participants n=5 Participants	25 Participants n=7 Participants	39 Participants n=5 Participants
Time Line Follow Back Any stimulant use	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Time Line Follow Back Any opioid use	19 Participants n=5 Participants	18 Participants n=7 Participants	37 Participants n=5 Participants
Time Line Follow Back Any cocaine use	15 Participants n=5 Participants	15 Participants n=7 Participants	30 Participants n=5 Participants
Time Line Follow Back Any sedative use	4 Participants n=5 Participants	6 Participants n=7 Participants	10 Participants n=5 Participants
Time Line Follow Back Percent alcohol drinking days	40.9 percentage of days STANDARD_DEVIATION 38.9 • n=5 Participants	48.5 percentage of days STANDARD_DEVIATION 40.3 • n=7 Participants	44.9 percentage of days STANDARD_DEVIATION 39.4 • n=5 Participants
Time Line Follow Back Percent cannabis use days	58.9 percentage of days STANDARD_DEVIATION 41.6 • n=5 Participants	55.7 percentage of days STANDARD_DEVIATION 41.6 • n=7 Participants	56.8 percentage of days STANDARD_DEVIATION 41.1 • n=5 Participants
Time Line Follow Back Percent stimulant use days	41.6 percentage of days STANDARD_DEVIATION 38.3 • n=5 Participants	54.4 percentage of days STANDARD_DEVIATION 41.4 • n=7 Participants	47.5 percentage of days STANDARD_DEVIATION 39.5 • n=5 Participants
Time Line Follow Back Percent opioid use days	77.5 percentage of days STANDARD_DEVIATION 36.5 • n=5 Participants	80.6 percentage of days STANDARD_DEVIATION 31.3 • n=7 Participants	79.1 percentage of days STANDARD_DEVIATION 33.6 • n=5 Participants
Time Line Follow Back Percent cocaine use days	57.1 percentage of days STANDARD_DEVIATION 37 • n=5 Participants	50.8 percentage of days STANDARD_DEVIATION 42.4 • n=7 Participants	53.9 percentage of days STANDARD_DEVIATION 39.2 • n=5 Participants
Time Line Follow Back Percent sedative use days	49.2 percentage of days STANDARD_DEVIATION 36.5 • n=5 Participants	56.8 percentage of days STANDARD_DEVIATION 45.7 • n=7 Participants	54.8 percentage of days STANDARD_DEVIATION 40.3 • n=5 Participants
Difficulty in Emotional Regulation (DERS)	105.6 Scores on a scale STANDARD_DEVIATION 28.8 • n=5 Participants	101.1 Scores on a scale STANDARD_DEVIATION 28.8 • n=7 Participants	103.3 Scores on a scale STANDARD_DEVIATION 29.4 • n=5 Participants
Five Factor Mindfulnes Questionaire (FFMQ)	71.6 Scores on a scale STANDARD_DEVIATION 16.1 • n=5 Participants	72.7 Scores on a scale STANDARD_DEVIATION 16.1 • n=7 Participants	72.1 Scores on a scale STANDARD_DEVIATION 15.2 • n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks (60 days baseline to end of treatment). Missing scores were imputed. Scores presented are controlled for baseline scores.

Population: Mean scale scores for participants at the end of treatment (baseline to end of treatment).

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=45 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=45 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Clinician-Administered Posttraumatic Stress Disorder Scale for DSM-5	16.5 score on a scale Standard Error 2.3	18.5 score on a scale Standard Error 2.4

SECONDARY outcome

Timeframe: 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.

Population: Mean scores for participants at 3 and 6 month follow-up visits. Missing data scores were imputed. Scores presented are controlled for baseline scores.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=45 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=45 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Clinician Administered Posttraumatic Stress Disorder Scale-5 (CAPS-5) 3 month follow-up	13.8 score on a scale Standard Error 2.4	16.1 score on a scale Standard Error 2.4
Clinician Administered Posttraumatic Stress Disorder Scale-5 (CAPS-5) 6 month follow-up	12.7 score on a scale Standard Error 2.5	13.3 score on a scale Standard Error 2.5

SECONDARY outcome

Timeframe: 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.

Population: Mean total Post Traumatic Symptom Severity Self Report (PSS-SR) scores for participants throughout the study period. Missing scores were imputed at different time periods. Scores presented are controlled for baseline scores.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=45 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=45 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 1	30.6 score on a scale Standard Error 1.8	29.2 score on a scale Standard Error 1.8
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 2	24.7 score on a scale Standard Error 1.8	28.3 score on a scale Standard Error 1.9
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 3	24 score on a scale Standard Error 1.9	28.5 score on a scale Standard Error 2
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 4	21.2 score on a scale Standard Error 1.9	24.3 score on a scale Standard Error 2
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 5	17.9 score on a scale Standard Error 2.0	20.2 score on a scale Standard Error 2.1
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 6	16 score on a scale Standard Error 2	20.3 score on a scale Standard Error 2.1
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 7	16.7 score on a scale Standard Error 2.1	20 score on a scale Standard Error 2.2
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) Week 8	17.4 score on a scale Standard Error 2	18.4 score on a scale Standard Error 2.1
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) 3 month follow-up	15.6 score on a scale Standard Error 2.1	17.2 score on a scale Standard Error 2.1
Post Traumatic Stress Disorder Symptom Scale- Self Report (PSS-SR) 6 month follow-up	11.5 score on a scale Standard Error 2.2	19 score on a scale Standard Error 2.1

SECONDARY outcome

Timeframe: 8 weeks (60 days from baseline to end of treatment).

Population: The mean percent days reporting use of alcohol and/or other substances (cannabis, stimulants, opioids, cocaine and sedatives) for those individuals who attended the end of treatment study visit (n=60) and reported any use during treatment. Those individuals who did not use alcohol or substances during treatment are not reported here. Different number of participants reported use of various different substances during treatment.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=32 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=28 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Time Line Follow Back (TLFB) PDD 8 weeks	11 percent of days Standard Deviation .11	10 percent of days Standard Deviation .1
Time Line Follow Back (TLFB) PDU cannabis 8 weeks	8 percent of days Standard Deviation .08	15 percent of days Standard Deviation .27
Time Line Follow Back (TLFB) PDU stimulants 8 weeks	11 percent of days Standard Deviation .0	2 percent of days Standard Deviation .0
Time Line Follow Back (TLFB) PDU opioids 8 weeks	23 percent of days Standard Deviation .21	—
Time Line Follow Back (TLFB) PDU cocaine 8 weeks	18 percent of days Standard Deviation .28	4 percent of days Standard Deviation .02
Time Line Follow Back (TLFB) PDU sedatives 8 weeks	1.6 percent of days Standard Deviation .005	1.4 percent of days Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Population: Mean of percent days reporting use of alcohol and/or substances (cannabis, stimulants, opioids, cocaine and sedative) for those participants who attended the 3 month follow-up visit (n=53) and reported any alcohol and/or substance use at the 3 month follow-up visit. Those participants who did not report any alcohol and/or substance use are not represented here. Different number of participants reported use of various different substances at the 3 month follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=26 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=27 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Time Line Follow Back (TLFB) PDD alcohol 3 month follow-up	21 percent of days Standard Deviation .28	15 percent of days Standard Deviation .14
Time Line Follow Back (TLFB) PDU cannabis 3 month follow-up	26 percent of days Standard Deviation .4	21 percent of days Standard Deviation .17
Time Line Follow Back (TLFB) PDU stimulants 3 month follow-up	10 percent of days Standard Deviation 0	38 percent of days Standard Deviation .41
Time Line Follow Back (TLFB) PDU opioids 3 month follow-up	48 percent of days Standard Deviation .11	39 percent of days Standard Deviation .21
Time Line Follow Back (TLFB) PDU cocaine 3 month follow-up	43 percent of days Standard Deviation .4	9 percent of days Standard Deviation .12
Time Line Follow Back (TLFB) PDU sedatives 3 month follow-up	—	24 percent of days Standard Deviation 0

SECONDARY outcome

Timeframe: 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.

Population: Mean percent days of use for participants attending (n=52) the 6 month follow-up visit and who reported use of alcohol and/or substances (cannabis, stimulants, opioids, cocaine and sedatives) at the 6 month follow-up visit. Individuals who did not report use of any alcohol and/or substances are not reported/represented here. Different number of participants reported use of various different substances at the 6 month follow-up visit.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=25 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=27 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Time Line Follow Back (TLFB) PDD alcohol 6 month follow-up	9 percent of days Standard Deviation .11	21 percent of days Standard Deviation .22
Time Line Follow Back (TLFB) PDU cannabis 6 month follow-up	18 percent of days Standard Deviation .27	17 percent of days Standard Deviation .25
Time Line Follow Back (TLFB) PDU stimulant 6 month follow-up	—	3 percent of days Standard Deviation .01
Time Line Follow Back (TLFB) PDU cocaine 6 month follow-up	1 percent of days Standard Deviation .16	27 percent of days Standard Deviation .16
Time Line Follow Back (TLFB) PDU sedatives 6 month follow-up	—	1 percent of days

SECONDARY outcome

Timeframe: 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.

Population: Number of drinks per drinking day for participants who attended the 8 week end of study visit and used alcohol during the 8 weeks of treatment (n=26). Those individuals who did not report alcohol use are not reported here.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=13 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=13 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Time Line Follow Back (TLFB)	2.9 drinks per drinking day Standard Deviation 2.4	2.5 drinks per drinking day Standard Deviation 2.3

SECONDARY outcome

Timeframe: 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.

Population: 3 months follow-up mean drinks per drinking day for those participants who reported any use of alcohol at the 3 month follow-up (90 days from end of treatment; n=18) visit. Participants who did not report any alcohol use are not reported here.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=8 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=10 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Time Line Follow Back (TLFB)	6.3 drinks per drinking day Standard Deviation 5.7	6.6 drinks per drinking day Standard Deviation 7.9

SECONDARY outcome

Timeframe: 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).

Population: Participants who reported any drinking at the 6 month follow-up visit (90 days from 3 month to 6 month follow-up visit: n=20). Those who reported no drinking are not included here.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=7 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=13 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Time Line Follow Back (TLFB)	2.5 drinks per drinking day Standard Deviation 1.7	3.7 drinks per drinking day Standard Deviation 3.1

SECONDARY outcome

Timeframe: 8 week end of treatment visit (60 days baseline to end of treatment)

Population: Participants who attended the 8 week end of study visit (N=60) are reported/represented here. Not all participants attended end of treatment study visits.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=32 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=28 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Five Factor Mindfulness Questionnaire (FFMQ)	83.3 score on a scale Standard Error 3.1	78.4 score on a scale Standard Error 3.3

SECONDARY outcome

Timeframe: 3 month follow-up (90 days from end of treatment to 3 month follow-up visit)

Population: Participants who attended the 3 month follow-up visit (N=53) are reported/represented here. Not all participants attended all study visits.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=26 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=27 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Five Factor Mindfulness Questionnaire (FFMQ)	82.7 score on a scale Standard Error 3.4	79.4 score on a scale Standard Error 3.4

SECONDARY outcome

Timeframe: 6 month follow-up (90 days from 3 month follow-up visit to 6 month follow-up visit)

Population: Participants who attended the 6 month follow-up visit (N=52) are reported/represented here. Not all participants attended all study visits.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=25 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=27 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Five Factor Mindfulness Questionnaire (FFMQ)	87.4 score on a scale Standard Error 3.5	79.3 score on a scale Standard Error 3.4

SECONDARY outcome

Timeframe: 8 week end of treatment (60 days baseline to end of treatment)

Population: Participants who attended the 8 week end of study visit (N=60) are reported/represented here. Not all participants attended all study visits.

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.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=32 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=28 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Difficulty in Emotion Regulation Scale (DERS)	80.9 score on a scale Standard Error 4.8	85.7 score on a scale Standard Error 5.2

SECONDARY outcome

Timeframe: 3 month follow-up (90 days end of treatment to 3 month follow-up)

Population: Participants who attended the 3 month follow-up visit (N=53) are reported/represented here. Not all participants attended all study visits.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=26 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=27 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Difficulty in Emotional Regulation Scale (DERS)	85.4 score on a scale Standard Error 5.5	83.4 score on a scale Standard Error 5.4

SECONDARY outcome

Timeframe: 6 month follow up (90 days from 3 month follow-up to 6 month follow-up)

Population: Participants who attended the 6 month follow-up visit (N=52) are reported/represented here. Not all participants attended all study visits.

Outcome measures

Outcome measures
Measure	Women Receiving MBRP Plus TAU n=25 Participants Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=27 Participants Women will only receive treatment as usual (TAU less trauma focused group).
Difficulty in Emotional Regulation Scale (DERS)	76.4 score on a scale Standard Error 5.7	81.7 score on a scale Standard Error 5.4

Adverse Events

Women Receiving MBRP Plus TAU

Serious events: 4 serious events

Other events: 28 other events

Deaths: 0 deaths

Women Receiving TAU

Serious events: 3 serious events

Other events: 20 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Women Receiving MBRP Plus TAU n=45 participants at risk Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=45 participants at risk Women will only receive treatment as usual (TAU less trauma focused group).
Psychiatric disorders Suicidal ideation	2.2% 1/45 • Number of events 1 • Approximately 8-9 months	2.2% 1/45 • Number of events 1 • Approximately 8-9 months
Infections and infestations Knee Infection	2.2% 1/45 • Number of events 1 • Approximately 8-9 months	0.00% 0/45 • Approximately 8-9 months
Injury, poisoning and procedural complications alcohol poisening	0.00% 0/45 • Approximately 8-9 months	2.2% 1/45 • Number of events 1 • Approximately 8-9 months
Injury, poisoning and procedural complications Physical Assault	0.00% 0/45 • Approximately 8-9 months	2.2% 1/45 • Number of events 1 • Approximately 8-9 months
Hepatobiliary disorders gall bladder stones	2.2% 1/45 • Number of events 1 • Approximately 8-9 months	0.00% 0/45 • Approximately 8-9 months
Psychiatric disorders Severe opioid withdrawal	2.2% 1/45 • Number of events 1 • Approximately 8-9 months	0.00% 0/45 • Approximately 8-9 months

Other adverse events

Other adverse events
Measure	Women Receiving MBRP Plus TAU n=45 participants at risk Women will receive the Mindfulness Based Relapse Prevention (MBRP) plus treatment as usual (TAU less trauma focused group). 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.	Women Receiving TAU n=45 participants at risk Women will only receive treatment as usual (TAU less trauma focused group).
Psychiatric disorders Anxiety	8.9% 4/45 • Number of events 4 • Approximately 8-9 months	4.4% 2/45 • Number of events 2 • Approximately 8-9 months
Musculoskeletal and connective tissue disorders Back pain	13.3% 6/45 • Number of events 6 • Approximately 8-9 months	4.4% 2/45 • Number of events 2 • Approximately 8-9 months
Infections and infestations Bronchitis	8.9% 4/45 • Number of events 4 • Approximately 8-9 months	2.2% 1/45 • Number of events 1 • Approximately 8-9 months
Infections and infestations Cold	15.6% 7/45 • Number of events 7 • Approximately 8-9 months	11.1% 5/45 • Number of events 5 • Approximately 8-9 months
Psychiatric disorders Depressed mood	8.9% 4/45 • Number of events 4 • Approximately 8-9 months	6.7% 3/45 • Number of events 3 • Approximately 8-9 months
Infections and infestations Flu	11.1% 5/45 • Number of events 5 • Approximately 8-9 months	2.2% 1/45 • Number of events 1 • Approximately 8-9 months
Nervous system disorders Headache	8.9% 4/45 • Number of events 4 • Approximately 8-9 months	4.4% 2/45 • Number of events 2 • Approximately 8-9 months
Gastrointestinal disorders Nausea	13.3% 6/45 • Number of events 6 • Approximately 8-9 months	2.2% 1/45 • Number of events 1 • Approximately 8-9 months
Gastrointestinal disorders Stomach pain	15.6% 7/45 • Number of events 7 • Approximately 8-9 months	11.1% 5/45 • Number of events 5 • Approximately 8-9 months
Infections and infestations Teeth Decay	4.4% 2/45 • Number of events 2 • Approximately 8-9 months	11.1% 5/45 • Number of events 5 • Approximately 8-9 months

Additional Information

Therese K Killeen PhD, Principal Investigator

Medical University of South Carolina

Phone: 843-792-5232

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place