Trial Outcomes & Findings for A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment (NCT NCT03505749)

NCT ID: NCT03505749

Last Updated: 2022-03-02

Results Overview

Number of participants who completed informed consent and screening, with at least 30% identifying as racial and/or ethnic minority.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 96 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2022-03-02

Participant Flow

Participants were recruited from community-based residential and intensive outpatient chemical dependency treatment centers in the Pacific Northwest. Facilities included three residential and two IOP clinics. Approximately 95% of women within these treatment facilities had a lifetime history of trauma, and approximately 88% were dually diagnosed with PTSD. Counselors and administrators assisted with recruitment via word of mouth, flyers, and announcements at weekly group meetings.

Participants who enrolled in the study agreed to complete an informed consent and screening procedure. Those who were eligible via our screening procedure completed baseline assessments prior to group assignment.

Participant milestones

Measure	TI-MBRP Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.	Standard MBRP The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Overall Study STARTED	38	45
Overall Study COMPLETED	22	28
Overall Study NOT COMPLETED	16	17

Reasons for withdrawal

Measure	TI-MBRP Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.	Standard MBRP The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Overall Study Lost to Follow-up	7	11
Overall Study Withdrawal by Subject	6	0
Overall Study Discharged from treatment	3	6

Baseline Characteristics

A Trauma Informed Adaptation of Mindfulness-Based Relapse Prevention for Women in Substance Use Treatment

Baseline characteristics by cohort

Measure	TI-MBRP n=38 Participants Trauma-Integrated Mindfulness-Based Relapse Prevention (TI-MBRP) will be a 4-week intervention integrating trauma intervention approaches based on Cognitive Processing Therapy (CPT), and gender-responsive interventions, into standard Mindfulness-Based Relapse Prevention (MBRP). TI-MBRP honors the spirit and cognitive-behavioral foundation of MBRP while introducing components of CPT. Each TI-MBRP session will include mindfulness practices that bring awareness to cognitive and behavioral processes of substance use, and how substance use may function as a mechanism to cope with trauma symptoms. Clients are trained to observe internal, triggering stimuli without reactively attempting to avoid these experiences through substance use as well as complete exercises that promote cognitive and emotional processing of traumatic events. Moreover, gender-focused themes will be discussed in relation to SUD and PTSD recovery such as parenting, interpersonal relationships, and empowerment.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.	Total n=83 Participants Total of all reporting groups
Age, Continuous	37.22 years STANDARD_DEVIATION 10.28 • n=5 Participants	32.55 years STANDARD_DEVIATION 7.86 • n=7 Participants	34.67 years STANDARD_DEVIATION 9.27 • n=5 Participants
Sex: Female, Male Female	38 Participants n=5 Participants	45 Participants n=7 Participants	83 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	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	33 Participants n=5 Participants	40 Participants n=7 Participants	73 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 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	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) White	30 Participants n=5 Participants	29 Participants n=7 Participants	59 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	6 Participants n=7 Participants	8 Participants n=5 Participants
Region of Enrollment United States	38 participants n=5 Participants	45 participants n=7 Participants	83 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline

Population: Women in residential or intensive outpatient treatment substance use treatment from one of five clinics participating in the study during the time of study recruitment.

Number of participants who completed informed consent and screening, with at least 30% identifying as racial and/or ethnic minority.

Outcome measures

Measure	All Women Who Were Interested in Participation n=96 Participants All women who underwent informed consent and screening procedures.	Standard MBRP The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Recruitment	96 Participants	—

PRIMARY outcome

Timeframe: Baseline

Population: Women with comorbid PTSD and substance use disorder.

Percentage of eligible individuals who completed baseline measures.

Outcome measures

Measure	All Women Who Were Interested in Participation n=96 Participants All women who underwent informed consent and screening procedures.	Standard MBRP The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Enrollment	83 Participants	—

PRIMARY outcome

Timeframe: 8-weeks

Percentage of participants who completed 1-month follow-up measures.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Retention	22 Participants	28 Participants

PRIMARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

Population: Women with comorbid PTSD and Substance Use Disorder

20-item screening instrument assessing PTSD symptoms. Each item is scored 0 - 4 (0 = Not at all, 1 = A little bit, 2 = Moderately, 3 = Quite a bit, 4 = Extremely). Total scores range from 0 - 80. Higher values indicate greater PTSD symptom severity.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores Baseline	43.51 score on a scale Standard Deviation 15.28	48.55 score on a scale Standard Deviation 14.39
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores 4-weeks	35.41 score on a scale Standard Deviation 15.79	30.50 score on a scale Standard Deviation 13.86
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores 8-weeks	28.75 score on a scale Standard Deviation 14.98	21.82 score on a scale Standard Deviation 14.32
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores 12-weeks	30.17 score on a scale Standard Deviation 15.66	27.04 score on a scale Standard Deviation 16.50
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores 24-weeks	33.53 score on a scale Standard Deviation 18.50	29.84 score on a scale Standard Deviation 17.21
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores 36-weeks	27.67 score on a scale Standard Deviation 16.73	29.11 score on a scale Standard Deviation 14.72
Trauma Symptoms by the Posttraumatic Checklist - Civilian (PCL-5) Scores 52-weeks	28.21 score on a scale Standard Deviation 21.01	28.69 score on a scale Standard Deviation 19.37

PRIMARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

Population: Women with PTSD and substance use disorder.

5 items assessing frequency, intensity, and duration of alcohol or drug craving. Each item is scored 0-6 (0 = Never, 1 = Rarely , 2 = Occasionally , 3 = Sometimes, 4 = Often, 5 = Most of the time, 6 = Nearly all the time). Total scale scores range from 0 - 30. Higher scores indicate greater severity of alcohol and substance craving.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Craving by the Penn Alcohol Craving Scale (PACS) Scores Baseline	20.5 score on a scale Standard Deviation 7.76	21.31 score on a scale Standard Deviation 8.71
Craving by the Penn Alcohol Craving Scale (PACS) Scores 4-weeks	8.33 score on a scale Standard Deviation 5.51	10.36 score on a scale Standard Deviation 8.48
Craving by the Penn Alcohol Craving Scale (PACS) Scores 8-weeks	8.00 score on a scale Standard Deviation 5.03	6.86 score on a scale Standard Deviation 7.14
Craving by the Penn Alcohol Craving Scale (PACS) Scores 12-weeks	7.38 score on a scale Standard Deviation 5.04	7.18 score on a scale Standard Deviation 6.61
Craving by the Penn Alcohol Craving Scale (PACS) Scores 24-weeks	9.30 score on a scale Standard Deviation 7.41	5.15 score on a scale Standard Deviation 4.71
Craving by the Penn Alcohol Craving Scale (PACS) Scores 36-weeks	8.67 score on a scale Standard Deviation 7.85	9.33 score on a scale Standard Deviation 7.61
Craving by the Penn Alcohol Craving Scale (PACS) Scores 52-weeks	8.07 score on a scale Standard Deviation 6.19	9.15 score on a scale Standard Deviation 7.69

PRIMARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

This self-report measure assesses frequency of alcohol and substance use, and misuse of prescription medication over the past 2 weeks, 30 days, and 3 months. Items are on a Likert scale, where 0 = "Not at all", 1 = "One or two days", 2 = "Several days", 3 = "More than half the days", and 4 = "Nearly every day". Total scare scores range from 0 - 44. Higher scores indicate greater frequency of use.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores Baseline	.421 score on a scale Standard Deviation 1.26	1.15 score on a scale Standard Deviation 2.67
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores 4-weeks	.454 score on a scale Standard Deviation 1.51	.105 score on a scale Standard Deviation .459
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores 8-weeks	.333 score on a scale Standard Deviation .707	.000 score on a scale Standard Deviation .000
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores 12-weeks	.118 score on a scale Standard Deviation .332	.278 score on a scale Standard Deviation 1.18
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores 24-weeks	0.00 score on a scale Standard Deviation 0.00	0.00 score on a scale Standard Deviation 0.00
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores 36-weeks	2.36 score on a scale Standard Deviation 5.92	.111 score on a scale Standard Deviation .333
Frequency of Alcohol and Substance Use by the NIDA Alcohol, Smoking, and Substance Involvement Test (ASSIST) Scores 52-weeks	4.14 score on a scale Standard Deviation 11.62	.846 score on a scale Standard Deviation 2.51

SECONDARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

18-item self-report measure of experiential avoidance and psychological inflexibility related to substance abuse behaviors. Each item is scaled from 1 - 7, where 1 = "Never true", 2 = "Very seldom true", 3 = "Seldom true", 4 = "Sometimes true", 5 = "Frequently true", 6 = "Almost always true", and 7 = "Always true". Total scores range from 18 to 126. Higher scores indicate less psychological flexibility with regard to substance use.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores Baseline	84.13 score on a scale Standard Deviation 19.09	87.36 score on a scale Standard Deviation 18.43
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores 4-weeks	94.19 score on a scale Standard Deviation 15.64	100.37 score on a scale Standard Deviation 13.86
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores 8-weeks	97.77 score on a scale Standard Deviation 14.53	105.5 score on a scale Standard Deviation 13.49
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores 12-weeks	99.12 score on a scale Standard Deviation 16.07	107.86 score on a scale Standard Deviation 13.75
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores 24-weeks	89.69 score on a scale Standard Deviation 31.67	109.38 score on a scale Standard Deviation 12.45
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores 36-weeks	101.93 score on a scale Standard Deviation 21.35	110.22 score on a scale Standard Deviation 11.61
Psychological Inflexibility and Experiential Avoidance by the Acceptance and Action Questionnaire - Substance Abuse (AAQ-SA) Scores 52-weeks	103.79 score on a scale Standard Deviation 20.98	107.08 score on a scale Standard Deviation 13.35

SECONDARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

36-item self-report measure of reaction to negative affect. This measure contains 6 subscales and a total score, and only the 6-item non-acceptance of emotion subscale (α = 0.85) was be used, which measures the degree to which an individual accepts their reaction to negative emotions. Items are scaled from 1 - 6, where 1 = "Almost never (1 - 10%)", 2 = "Sometimes (11 - 35%)", 3 = About half the time (36 - 65%)", 4 = "Most of the time (66 - 90%)", and 5 = "Almost always (91 - 99%)". Total subscale scores range from 6 to 30. Higher scores indicate less acceptance of negative affective states.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) Baseline	17.10 score on a scale Standard Deviation 5.59	17.55 score on a scale Standard Deviation 5.83
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) 4-weeks	14.66 score on a scale Standard Deviation 4.32	13.27 score on a scale Standard Deviation 5.04
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) 8-weeks	14.26 score on a scale Standard Deviation 6.73	11.77 score on a scale Standard Deviation 4.92
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) 12-weeks	14.62 score on a scale Standard Deviation 5.55	10.86 score on a scale Standard Deviation 5.55
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) 24-weeks	13.70 score on a scale Standard Deviation 5.06	10.92 score on a scale Standard Deviation 4.80
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) 36-weeks	13.07 score on a scale Standard Deviation 7.07	11.78 score on a scale Standard Deviation 5.33
Difficulties in Emotion Regulation Scale - Non-acceptance (DERS-NA) 52-weeks	12.00 score on a scale Standard Deviation 5.52	11.53 score on a scale Standard Deviation 4.39

SECONDARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

24-item, self-report measure of mindfulness. The FFMQ-SF contains a total mindfulness score and 5 subscale scores measuring awareness, non-judgment, describing, observing, and non-reactivity. Items are scaled from 1 - 5, where 1 = "Never or very rarely true", 2 = "Rarely true", 3 = "Sometimes true", 4 = "Often true", and 5 = "Very often or always true". Subscale scores are combined to achieve a total score, which are presented in the data table below. Total scores range from 24 to 120. Higher scores indicate greater levels of mindfulness.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) Baseline	74.48 score on a scale Standard Deviation 11.85	72.71 score on a scale Standard Deviation 10.41
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) 4-weeks	78.19 score on a scale Standard Deviation 11.03	81.00 score on a scale Standard Deviation 12.65
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) 8-weeks	82.50 score on a scale Standard Deviation 8.87	88.10 score on a scale Standard Deviation 12.20
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) 12-weeks	80.29 score on a scale Standard Deviation 12.48	88.50 score on a scale Standard Deviation 14.49
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) 24-weeks	80.77 score on a scale Standard Deviation 12.13	93.69 score on a scale Standard Deviation 13.57
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) 36-weeks	88.53 score on a scale Standard Deviation 14.05	88.44 score on a scale Standard Deviation 12.96
Five Facet Mindfulness Questionnaire - Short Form (FFMQ-SF) 52-weeks	88.00 score on a scale Standard Deviation 12.27	91.38 score on a scale Standard Deviation 15.86

SECONDARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

The CRI is a self-report, 48-item questionnaire assessing coping resources in stressful situations, with subscales measuring approach-based coping and avoidant coping in difficult situations. Items are on a 4-point Likert scale varying from "Not at all" to "Fairly often". Subscale scores on approach- and avoidant-based coping range from 0 to 72, and each contain 24 items. Higher scores on the approach-based coping subscale indicates greater use of approach-based coping strategies when faced with a stressor. Higher scores on the avoidance-based coping subscale indicates greater use of avoidant-based coping strategies when faced with a stressor.

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Coping Responses Inventory (CRI) Baseline Avoidance	15.72 score on a scale Standard Deviation 9.89	22.05 score on a scale Standard Deviation 14.07
Coping Responses Inventory (CRI) Baseline Approach	23.52 score on a scale Standard Deviation 15.58	28.77 score on a scale Standard Deviation 17.36
Coping Responses Inventory (CRI) 4-weeks Avoidance	14.97 score on a scale Standard Deviation 8.64	16.51 score on a scale Standard Deviation 11.56
Coping Responses Inventory (CRI) 4-weeks Approach	27.80 score on a scale Standard Deviation 10.89	31.27 score on a scale Standard Deviation 16.36
Coping Responses Inventory (CRI) 8-weeks Avoidance	12.50 score on a scale Standard Deviation 9.50	15.03 score on a scale Standard Deviation 10.46
Coping Responses Inventory (CRI) 8-weeks Approach	28.68 score on a scale Standard Deviation 13.70	33.14 score on a scale Standard Deviation 18.07
Coping Responses Inventory (CRI) 12-weeks Avoidance	30.52 score on a scale Standard Deviation 11.01	28.41 score on a scale Standard Deviation 9.53
Coping Responses Inventory (CRI) 12-weeks Approach	50.41 score on a scale Standard Deviation 9.51	48.57 score on a scale Standard Deviation 13.41
Coping Responses Inventory (CRI) 24-weeks Avoidance	26.00 score on a scale Standard Deviation 8.40	23.85 score on a scale Standard Deviation 6.96
Coping Responses Inventory (CRI) 24-weeks Approach	44.83 score on a scale Standard Deviation 13.66	50.54 score on a scale Standard Deviation 12.73
Coping Responses Inventory (CRI) 36-weeks Avoidance	23.33 score on a scale Standard Deviation 6.98	22.67 score on a scale Standard Deviation 6.52
Coping Responses Inventory (CRI) 36-weeks Approach	43.20 score on a scale Standard Deviation 13.43	46.22 score on a scale Standard Deviation 15.17
Coping Responses Inventory (CRI) 52-weeks Avoidance	22.86 score on a scale Standard Deviation 9.20	30.54 score on a scale Standard Deviation 13.84
Coping Responses Inventory (CRI) 52-weeks Approach	44.21 score on a scale Standard Deviation 12.04	50.84 score on a scale Standard Deviation 12.27

SECONDARY outcome

Timeframe: Baseline, 4-weeks, 8-weeks, 12-weeks, 24-weeks, 36-weeks, 52-weeks

8-item brief self-report questionnaire measuring confidence in avoiding, abstaining or moderating substance use across 8 categories of relapse precipitants. Items are scaled from 0 - 100 in increments of 20, where 0 = "Not confident at all" and 100 = "Very confident".

Outcome measures

Measure	All Women Who Were Interested in Participation n=38 Participants All women who underwent informed consent and screening procedures.	Standard MBRP n=45 Participants The Treatment as Usual (TAU) group implemented for this trial will be the standard protocol for Mindfulness-Based Relapse Prevention (MBRP). MBRP is a 4-week exposure-based intervention that integrates integrating mindfulness and acceptance-based techniques with cognitive-behavioral approaches and psycho-education to increase awareness of patterns associated with addictive behaviors and individual factors precipitating and maintaining substance use. These skills are also used to train individuals in responding skillfully in high-risk situations associated with use.
Drug Taking Confidence Questionnaire Baseline	43.36 percentage of confidence in abstaining Standard Deviation 21.58	39.87 percentage of confidence in abstaining Standard Deviation 27.33
Drug Taking Confidence Questionnaire 4-weeks	57.05 percentage of confidence in abstaining Standard Deviation 19.12	61.22 percentage of confidence in abstaining Standard Deviation 20.98
Drug Taking Confidence Questionnaire 8-weeks	55.97 percentage of confidence in abstaining Standard Deviation 23.68	65.46 percentage of confidence in abstaining Standard Deviation 19.37
Drug Taking Confidence Questionnaire 12-weeks	63.17 percentage of confidence in abstaining Standard Deviation 15.75	63.23 percentage of confidence in abstaining Standard Deviation 24.18
Drug Taking Confidence Questionnaire 24-weeks	55.60 percentage of confidence in abstaining Standard Deviation 22.01	65.08 percentage of confidence in abstaining Standard Deviation 20.80
Drug Taking Confidence Questionnaire 36-weeks	62.27 percentage of confidence in abstaining Standard Deviation 21.93	72.00 percentage of confidence in abstaining Standard Deviation 10.15
Drug Taking Confidence Questionnaire 52-weeks	62.14 percentage of confidence in abstaining Standard Deviation 20.63	67.85 percentage of confidence in abstaining Standard Deviation 12.59

Adverse Events

TI-MBRP

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard MBRP

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

Dr. Vanessa Somohano, Postdoctoral Research Fellow

VA Portland Health Care System

Phone: 503-220-8262

Email: vanessa.somohano@va.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place