Trial Outcomes & Findings for Mindfulness Based Relapse Prevention: Efficacy and Mechanisms (NCT NCT01159535)

NCT ID: NCT01159535

Last Updated: 2016-08-15

Results Overview

Self reported use of alcohol and or illicit substances over the previous 30 days

• Recruitment status: COMPLETED
• Study phase: PHASE1/PHASE2
• Target enrollment: 286 participants
• Primary outcome timeframe: 30 days previous, assessed at 12-month follow-up
• Results posted on: 2016-08-15

Participant Flow

Participant milestones

Measure	Mindfulness Based Relapse Prevention (MBRP) Mindfulness Based Relapse Prevention Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.	Relapse Prevention (RP) The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving. Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)	Treatment as Usual (TAU) All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis. Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.
Overall Study STARTED	103	88	95
Overall Study COMPLETED	79	64	64
Overall Study NOT COMPLETED	24	24	31

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Mindfulness Based Relapse Prevention: Efficacy and Mechanisms

Baseline characteristics by cohort

Measure	Mindfulness Based Relapse Prevention (MBRP) n=103 Participants Mindfulness Based Relapse Prevention: The MBRP intervention comprises 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.	Relapse Prevention (RP) n=88 Participants The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving. Relapse Prevention: intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants)	Treatment as Usual n=95 Participants All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis. Treatment as Usual: All participants will be enrolled in continuing care services (including attendance at AA, NA, or other self-help groups) as recommended by their treatment providers. Thus, TAU participants will have ongoing support and monitoring by their continuing care providers on a regular basis.	Total n=286 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Categorical Between 18 and 65 years	103 Participants n=5 Participants	88 Participants n=7 Participants	95 Participants n=5 Participants	286 Participants n=4 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Age, Continuous	39.1 years STANDARD_DEVIATION 10.9 • n=5 Participants	38.9 years STANDARD_DEVIATION 10.9 • n=7 Participants	37.2 years STANDARD_DEVIATION 10.8 • n=5 Participants	38.5 years STANDARD_DEVIATION 10.9 • n=4 Participants
Sex: Female, Male Female	27 Participants n=5 Participants	32 Participants n=7 Participants	26 Participants n=5 Participants	85 Participants n=4 Participants
Sex: Female, Male Male	76 Participants n=5 Participants	56 Participants n=7 Participants	69 Participants n=5 Participants	201 Participants n=4 Participants
Region of Enrollment United States	103 participants n=5 Participants	88 participants n=7 Participants	95 participants n=5 Participants	286 participants n=4 Participants

PRIMARY outcome

Timeframe: 30 days previous, assessed at 12-month follow-up

Self reported use of alcohol and or illicit substances over the previous 30 days

Outcome measures

Measure	Mindfulness Based Relapse Prevention (MBRP) n=103 Participants Mindfulness Based Relapse Prevention Mindfulness Based Relapse Prevention: The MBRP intervention consisted of 8 weekly, 2-hour sessions delivered in small group format (10-14 participants) by two therapists (Bowen, et al., 2009). In MBRP, therapists facilitate discussions and exercises and introduce the meditation practice component.Group sessions include discussions of mindfulness as a means of coping with craving and painful cognitions/sensations that precipitate relapse, role-playing exercises, meditation practice, and homework assignments.	Relapse Prevention (RP) n=88 Participants The RP intervention is composed of 8 weekly 2-hour sessions delivered in small group format (10-14 participants). Individual sessions will be team-taught by two therapists and will include discussions of personal high-risk situations, coping skills assessment, and exercises to evaluate expectancies, self-efficacy, and craving.	Treatment as Usual (TAU) n=95 Participants Treatment as Usual included continuing care services (including attendance at Alcoholics Anonymous, Narcotics Anonymous, or other self-help groups) as recommended by their treatment providers.
Mean Number of Alcohol and Drug Use Days Out of Past 30 Mean number of heavy drinking days	1.44 number of days out of past 30 Standard Deviation 7.66	3.89 number of days out of past 30 Standard Deviation 12.17	4.65 number of days out of past 30 Standard Deviation 14.93
Mean Number of Alcohol and Drug Use Days Out of Past 30 Mean number of drug use days	3.06 number of days out of past 30 Standard Deviation 15.08	6.09 number of days out of past 30 Standard Deviation 19.05	4.63 number of days out of past 30 Standard Deviation 16.03

Adverse Events

Mindfulness-Based Relapse Prevention (MBRP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Relapse Prevention (RP)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Treatment as Usual (TAU)

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. Sarah Bowen

University of Washington

Phone: (206) 543-3452

Email: swbowen@uw.edu

Results disclosure agreements

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