An interventional study of Mindfulness Based Relapse Prevention (MBRP) and Twelve-Step Facilitation Intervention (TSF) in Substance Abuse, Depression and Anxiety Disorder, sponsored by VA Office of Research and Development. Completed at 2 sites in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-02-10.
Sponsored by VA Office of Research and Development · Not applicable, Interventional, and Treatment
This study will provide important information concerning the used of mindfulness-based relapse prevention (MBRP) as a continuing care strategy for Veterans who have completed primary treatment for a SUD. Most research is focused on the acute care of SUDs, but the risk of relapse to substance use is highest during the period immediately following treatment and attention to continuing care is critical. If this trial demonstrates that MBRP promotes sustained abstinence and improved functional outcomes, this will provide a valuable treatment to facilitate rehabilitation and recovery for Veterans with SUDs.
Rates of substance use disorders (SUDS) are high among military personnel and Veterans. While much research is focused on the acute care of SUDs, the risk of relapse to substance use following treatment is high and attention to continuing care is critical. New continuing care strategies targeting life-style change and improved coping mechanisms are important in facilitating maintenance of abstinence, promoting rehabilitation and functional recovery for Veterans with SUDs. Mindfulness-based relapse prevention (MBRP), a manualized treatment integrating cognitive-behavioral relapse prevention therapy with mindfulness practices, has shown promise in continuing care for SUDs. The proposed project will compare MBRP to a 12-Step Facilitation treatment as a continuing care strategy following primary treatment for SUDs. Participants will be randomized to participate in 8-weeks of weekly 90-minute, group-based MBRP or 12-Step Facilitation followed by a 10-month follow-up period with regular assessments of substance use, mood/anxiety symptoms, quality of life and functional outcomes. Two VAMC sites (Charleston and Tuscaloosa) with a history of successful collaboration will work together to recruit an adequate sample size to address the primary study questions within a 4-year period and to ensure generalizability of the results. If this trial demonstrates that MBRP promotes sustained abstinence and improved functional outcomes, this will provide a valuable treatment to facilitate rehabilitation and recovery for Veterans with SUDs.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 204 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
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Exclusion Criteria:
The Introductory session provides an orientation to the intervention, basic mindfulness techniques and general description of group sessions. Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan). The therapist reviews homework assignments, discusses challenges and participants are taught a variety of mindfulness meditation (MM) practices such as breath meditation, urge surfing, walking or movement meditation.
Behavioral: Mindfulness Based Relapse Prevention (MBRP)
The Introductory session covers the 12-Step view of addiction and therapy overview. The manual, originally developed for individual sessions, has been adapted for group delivery. The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics. The intervention involves helping participants understand and incorporate core principles of 12-Step approaches while encouraging active participation in 12-Step meetings and related activities. The primary goal is to promote abstinence by facilitating the patient's acceptance and surrender of addiction. Sessions begin with a check-in during which participants introduce themselves, report on meeting attendance and participation in related activities, any alcohol/drug use or craving to use. The remainder of the session focuses on discussion of the topic content followed by a "take home" summary and homework assignment.
Behavioral: Twelve-Step Facilitation Intervention (TSF)
Each session has a central theme/topic and consists of in-session experiential practice, discussions and homework assignments. Sessions begin with a check-in followed by a 20-30 minute meditation (i.e. body scan). The therapist reviews homework assignments, discusses challenges and participants are taught a variety of MM practices such as breath meditation, urge surfing, walking or movement meditation.
The primary goal is to promote abstinence by facilitating the patient's acceptance and surrender of addiction. Sessions begin with a check-in during which participants introduce themselves, report on meeting attendance and participation in related activities, any alcohol/drug use or craving to use. The remainder of the session focuses on discussion of the topic content followed by a "take home" summary and homework assignment.
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use in treatment up to 8 weeks will be assessed.
Time frame: Study Treatment Duration up to 8 Weeks
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports (Carey, 1997). Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use during treatment through10 months will be assessed.
Time frame: Study Treatment Duration through 10 Months Follow up
Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Participants that failed to return for any treatment or follow up visits are considered censored at study day 1.
Time frame: Study Treatment Duration through 10 Months
Mindfulness Acceptance and Awareness Scale (MAAS)
This is a 15-item self-report instrument rating the frequency of experiencing impaired moment-to-moment attention on a 6-point Likert scale. Scores range from 1- 6 with higher scores indicating higher levels of mindfulness. This measure explores the relationship between MAAS scores and treatment response.
Time frame: Baseline, End of treatment, 3 Months, 6 Months, 10 Months
Beck Depression Inventory 2
This 21-item self-report scale will be used to assess for worsening depression/suicidality in safety monitoring. Scores range from 0 - 63 with higher scores indicating more severe depression.
Time frame: Baseline, End of Treatment, 3 Months, 6 Months, 10 Months
Beck Anxiety Inventory
This 21-item self-report scale has symptom clusters reflecting neurophysiological, subjective, panic, and autonomic dimensions. Scores range from 0-63 with higher scores indicating more severe anxiety.
Time frame: Baseline, End of Treatment, 3 Months, 6 Months, 10 Months
Urine Drug Screen
Observed urine samples will be collected with a RapidCHECK Multi-Drug 10 Panel Test, which allows detection of tetrahydrocannabinol (THC)/marijuana, cocaine, phencyclidine, opiates, methamphetamines, methadone, amphetamines, barbiturates, benzodiazepines and uses concentrations levels established by the National Institute on Drug Abuse (NIDA) and the World Health Organization (WHO). Osmolality and temperature assessed at collection time to insure sample validity.
Time frame: Weekly, Week 8, 3 Months, 6 Months, 10 Months
EtG
The conjugated alcohol metabolite ethyl glucuronide (EtG) remains positive in urine for several days following cessation and is a useful biomarker of recent drinking in outpatient settings (Dahl 2011). This will be used as the primary biologic assessment of drinking status as breathalyzer tests only assess very recent alcohol use. The assay will be done in the Charleston VAMC laboratory on samples collected at baseline, end of treatment and 3-, 6-, and 10-month follow-up visits.
Time frame: Week 8, 3 Months, 6 Months, 10 Months
Addiction Severity Index, Lite
This standardized, multidimensional, semi-structured interview provides information concerning functioning in six domains commonly impacted by substance abuse: alcohol/drug, medical, psychiatric, legal, family/social and employment. The alcohol/drug scale composite score will be reported to determine severity of alcohol/drug problem severity. The average range is 0 (denoting a better outcome) to 1 ( denoting a worse outcome).
Time frame: 8 Weeks, 3 Months, 6 Months, 10 Months
Days Engaging in Structured/Productive Work Activities (PWAC)
The PWAC will be used to assess self-reported days engaged in structured, volunteer, or employed work activity of at least 1 hour in duration. VISTA queries using Compensated Work Therapy and Veterans Enrichment Program stop codes will be run for medical record corroboration. Activities outside of the VA will be included.
Time frame: Weekly, Week 8, 3 Months, 6 Months, 10 Months
Treatment Engagement: Treatment Attendance Calendar (TAC)
The TAC will be used to assess the total number of days treated for a substance abuse/mental health problem in the VA or other outpatient setting, 12-step or self-help group meetings, physician contacts and,hospitalization by treatment group. The TAC measure represent the total number of days experiencing any of these events by treatment group.
Time frame: Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
This 16-item scale, used to assess satisfaction with major areas of life function, has convergent and discriminant construct validity in chronic illness as evidenced by high correlations between the QOLS total score and Life Satisfaction Index. Scores range from 1 = 112 with higher scores indicating higher satisfaction with quality of life.
Time frame: Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months
Urine Drug Screen - End of Study
Observed urine samples will be collected with a RapidCHECK Multi-Drug 10 Panel Test, which allows detection of tetrahydrocannabinol (THC)/marijuana, cocaine, phencyclidine, opiates, methamphetamines, methadone, amphetamines, barbiturates, benzodiazepines and uses concentrations levels established by the National Institute on Drug Abuse (NIDA) and the World Health Organization (WHO). Osmolality and temperature assessed at collection time to insure sample validity.
Time frame: End of Study (up to 1 year)
MINI-International Neuropsychiatric Interview
The MINI is a well-standardized structured interview which is similar in sensitivity, specificity, and inter-rater reliability to other more lengthy diagnostic interviews, such as the Structured Clinical Interview for DSM-IV. A DSM-V version of the MINI is not available, so DSM-IV criteria will be utilized. The MINI will be used at baseline to assess psychiatric diagnoses for inclusion/exclusion and urn randomization purposes.
Time frame: Baseline
Montreal Cognitive Assessment (MOCA)
This brief, well-validated instrument will be used at baseline to screen for cognitive impairment that could interfere with ability to benefit from MBRP. A cut-off of 26/30 is considered normal. Scores range from 0 - 30 with lower scores indicating mores severe cognitive impairment.
Time frame: Baseline
| Milestone | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Started | 98 | 106 |
| Completed | 47 | 50 |
| Not completed | 51 | 56 |
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use in treatment up to 8 weeks will be assessed.
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Any Alcohol Use During Study Treatment | 8 | 12 |
| Any Illicit Substance Use During Study Treatment | 9 | 4 |
| Cigarette Use During Study Treatment | 46 | 62 |
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports (Carey, 1997). Quantity and frequency assessments as well as time-to-event measures can be obtained. Drug/alcohol use during treatment through10 months will be assessed.
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Any Alcohol Use | 25 | 37 |
| Any Binge Alcohol Use | 13 | 20 |
| Any Illicit Substance Use | 18 | 29 |
The TLFB will be used to obtain retrospective self-report of alcohol and illicit drug (e.g., cocaine, marijuana, stimulants, sedatives, opioids) use using calendar and memory prompts to stimulate recall. The TLFB yields consistently high test-retest correlations and correlates well with other self-reports and collateral reports. Quantity and frequency assessments as well as time-to-event measures can be obtained. Participants that failed to return for any treatment or follow up visits are considered censored at study day 1.
| Days to first relapse | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Relapse to any Alcohol Use | 110 (74 to 138) | 128 (45 to 195) |
| Relapse to Binge Alcohol Use | 95 (78 to 135) | 196 (94 to 298) |
| Relapse to any Illicit Substance Use | 1 (1 to 265) | 48 (1 to 293) |
This is a 15-item self-report instrument rating the frequency of experiencing impaired moment-to-moment attention on a 6-point Likert scale. Scores range from 1- 6 with higher scores indicating higher levels of mindfulness. This measure explores the relationship between MAAS scores and treatment response.
| units on a scale | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Baseline | 3.99 ± 0.10 | 4.12 ± 0.1 |
| End of Treatment | 4.04 ± 0.12 | 4.26 ± 0.14 |
| 3 Months | 4.10 ± 0.14 | 4.55 ± 0.15 |
| 6 Months | 3.93 ± 0.17 | 4.49 ± 0.16 |
| 10 Months | 4.02 ± 0.17 | 4.58 ± 0.17 |
This 21-item self-report scale will be used to assess for worsening depression/suicidality in safety monitoring. Scores range from 0 - 63 with higher scores indicating more severe depression.
| units on a scale | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Baseline | 15.28 ± 0.97 | 14.26 ± 0.95 |
| End of Treatment | 8.96 ± 1.12 | 7.02 ± 0.97 |
| 3 Months | 11.75 ± 1.28 | 8.93 ± 1.24 |
| 6 Months | 12.02 ± 1.28 | 9.50 ± 1.29 |
| 10 Months | 12.15 ± 1.44 | 9.17 ± 1.33 |
This 21-item self-report scale has symptom clusters reflecting neurophysiological, subjective, panic, and autonomic dimensions. Scores range from 0-63 with higher scores indicating more severe anxiety.
| units on a scale | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Baseline | 14.99 ± 1.22 | 16.28 ± 1.42 |
| End of Treatment | 14.94 ± 1.64 | 11.09 ± 1.65 |
| 3 Months | 14.24 ± 1.74 | 10.46 ± 1.8 |
| 6 Months | 14.2 ± 1.76 | 11.40 ± 1.53 |
| 10 months | 14.15 ± 1.72 | 12.90 ± 1.91 |
Observed urine samples will be collected with a RapidCHECK Multi-Drug 10 Panel Test, which allows detection of tetrahydrocannabinol (THC)/marijuana, cocaine, phencyclidine, opiates, methamphetamines, methadone, amphetamines, barbiturates, benzodiazepines and uses concentrations levels established by the National Institute on Drug Abuse (NIDA) and the World Health Organization (WHO). Osmolality and temperature assessed at collection time to insure sample validity.
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Week 1 | 0 | 0 |
| Week 2 | 1 | 3 |
| Week 3 | 2 | 2 |
| Week 4 | 0 | 2 |
| Week 5 | 0 | 1 |
| Week 6 | 0 | 1 |
| Week 7 | 0 | 2 |
| Week 8 | 0 | 3 |
| 3 Months | 3 | 5 |
| 6 Months | 2 | 6 |
| 10 Months | 8 | 6 |
The conjugated alcohol metabolite ethyl glucuronide (EtG) remains positive in urine for several days following cessation and is a useful biomarker of recent drinking in outpatient settings (Dahl 2011). This will be used as the primary biologic assessment of drinking status as breathalyzer tests only assess very recent alcohol use. The assay will be done in the Charleston VAMC laboratory on samples collected at baseline, end of treatment and 3-, 6-, and 10-month follow-up visits.
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Week 8 | 4 | 9 |
| 3 Month | 3 | 1 |
| 6 Month | 2 | 1 |
| 10 Month | 1 | 1 |
This standardized, multidimensional, semi-structured interview provides information concerning functioning in six domains commonly impacted by substance abuse: alcohol/drug, medical, psychiatric, legal, family/social and employment. The alcohol/drug scale composite score will be reported to determine severity of alcohol/drug problem severity. The average range is 0 (denoting a better outcome) to 1 ( denoting a worse outcome).
| score on a scale | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| 8 Weeks | .1186 ± .1209 | .1180 ± .1368 |
| 3 Months | .1115 ± .1651 | .0877 ± .1452 |
| 6 Months | .0764 ± .1502 | .1124 ± .1721 |
| 10 Months | .0806 ± .1215 | .1212 ± .1428 |
The PWAC will be used to assess self-reported days engaged in structured, volunteer, or employed work activity of at least 1 hour in duration. VISTA queries using Compensated Work Therapy and Veterans Enrichment Program stop codes will be run for medical record corroboration. Activities outside of the VA will be included.
| days reported | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Week 1 | 1 (0 to 4) | 0 (0 to 3) |
| Week 2 | 0 (0 to 5) | 0 (0 to 3) |
| Week 3 | 2 (0 to 6) | 0 (0 to 3) |
| Week 4 | 2 (0 to 6) | 1 (0 to 5) |
| Week 5 | 2 (0 to 7) | 1 (0 to 5) |
| Week 6 | 3 (0 to 6) | 1 (0 to 5) |
| Week 7 | 2 (0 to 6) | 1 (0 to 5) |
| Week 8 | 2.5 (0 to 7) | 1 (0 to 7.5) |
| 3 Months | 5.5 (0 to 51.5) | 12 (0 to 49) |
| 6 Months | 5 (0 to 60) | 21.5 (0 to 54.5) |
| 10 Months | 0 (0 to 8) | 0 (0 to 15) |
The TAC will be used to assess the total number of days treated for a substance abuse/mental health problem in the VA or other outpatient setting, 12-step or self-help group meetings, physician contacts and,hospitalization by treatment group. The TAC measure represent the total number of days experiencing any of these events by treatment group.
| days reported | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Week 1 | 6 (0 to 13) | 4 (1 to 9) |
| Week 2 | 4 (1 to 7) | 4 (1 to 6) |
| Week 3 | 3 (1 to 7) | 3 (1 to 7) |
| Week 4 | 3 (0 to 8) | 3 (2 to 6) |
| Week 5 | 4 (1 to 7) | 4 (2 to 7) |
| Week 6 | 4 (1 to 6) | 3 (1 to 6) |
| Week 7 | 3 (1 to 4) | 3 (1 to 6) |
| Week 8 | 3 (0 to 6) | 3 (1 to 6.5) |
| 3 Months | 8.5 (1.5 to 42) | 16 (3 to 45) |
| 6 Months | 4 (0 to 26) | 12 (2 to 34.5) |
| 10 Months | 0 (0 to 8) | 0 (0 to 10) |
This 16-item scale, used to assess satisfaction with major areas of life function, has convergent and discriminant construct validity in chronic illness as evidenced by high correlations between the QOLS total score and Life Satisfaction Index. Scores range from 1 = 112 with higher scores indicating higher satisfaction with quality of life.
| units on a scale | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Baseline | 74 ± 16 | 73 ± 18 |
| Week 8 | 75 ± 16 | 81 ± 17 |
| 3 Months | 75 ± 15 | 80 ± 19 |
| 6 Months | 74 ± 17 | 80 ± 16 |
| 10 Months | 78 ± 16 | 80 ± 15 |
Observed urine samples will be collected with a RapidCHECK Multi-Drug 10 Panel Test, which allows detection of tetrahydrocannabinol (THC)/marijuana, cocaine, phencyclidine, opiates, methamphetamines, methadone, amphetamines, barbiturates, benzodiazepines and uses concentrations levels established by the National Institute on Drug Abuse (NIDA) and the World Health Organization (WHO). Osmolality and temperature assessed at collection time to insure sample validity.
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| THC | 8 | 6 |
| Coc | 10 | 7 |
| PCP | 0 | 1 |
| OPI | 0 | 1 |
| MET | 1 | 0 |
| MTD | 1 | 0 |
| AMP | 1 | 0 |
| BAR | 1 | 0 |
| BZO | 0 | 1 |
| OXY | 2 | 0 |
| MDMA | 0 | 0 |
The MINI is a well-standardized structured interview which is similar in sensitivity, specificity, and inter-rater reliability to other more lengthy diagnostic interviews, such as the Structured Clinical Interview for DSM-IV. A DSM-V version of the MINI is not available, so DSM-IV criteria will be utilized. The MINI will be used at baseline to assess psychiatric diagnoses for inclusion/exclusion and urn randomization purposes.
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| MDE (Current) | 16 | 10 |
| MDE (Past) | 49 | 51 |
| MDD (Current) | 9 | 6 |
| MDD (Past) | 37 | 35 |
| Manic Episode (Current) | 4 | 3 |
| Manic Episode (Past) | 7 | 10 |
| Hypomanic Episode (Current) | 0 | 0 |
| Hypomanic Episode (Past) | 0 | 3 |
| Bipolar 1 (Current) | 0 | 0 |
| Bipolar 1 (Past) | 4 | 7 |
| Bipolar Unspec (Current) | 0 | 0 |
| Bipolar Unspec (Past) | 0 | 0 |
| Bipolar Unspec w/ Psych (Current) | 0 | 0 |
| Bipolar Unspec w/ Psych (Past) | 0 | 1 |
| Psychotic Disorder (Past Month) | 1 | 1 |
| Psychotic Disorder (Lifetime) | 1 | 7 |
| Mood Disorder w/ Psych (Current) | 1 | 1 |
| Mood Disorder w/ Psych (Lifetime) | 6 | 5 |
| Panic Disorder (Past Month) | 6 | 13 |
| Panic Disorder (Lifetime) | 10 | 18 |
| Agoraphobia (Current) | 16 | 11 |
| Social Anxiety (Current) | 16 | 12 |
| OCD (Current) | 4 | 3 |
| PTSD (Current) | 25 | 23 |
| AUD (Past 12 Mo) | 63 | 79 |
| SUD (Past 12 Mo) | 67 | 74 |
This brief, well-validated instrument will be used at baseline to screen for cognitive impairment that could interfere with ability to benefit from MBRP. A cut-off of 26/30 is considered normal. Scores range from 0 - 30 with lower scores indicating mores severe cognitive impairment.
| units on a scale | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Montreal Cognitive Assessment (MOCA) | 25.8 ± 2.6 | 25.9 ± 2.9 |
Weekly study visit and follow-up visit attendance
| Participants | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Week 1 | 69 | 93 |
| Week 2 | 68 | 77 |
| Week 3 | 59 | 76 |
| Week 4 | 51 | 68 |
| Week 5 | 55 | 65 |
| Week 6 | 49 | 61 |
| Week 7 | 39 | 61 |
| Week 8 | 51 | 67 |
| 3 Months | 50 | 55 |
| 6 Months | 46 | 50 |
| 10 Months | 47 | 50 |
Collected over Study treatment, 8 weeks, follow-up, up to 10 months. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | 1/98 (1%) | 14/98 (14.3%) | 14/98 (14.3%) |
| Twelve-Step Facilitation Intervention (TSF) | 1/106 (0.9%) | 15/106 (14.2%) | 18/106 (17%) |
| Event | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| Hernia surgerySurgical and medical procedures | 0/98 | 1/1 |
| Relapse to Substance Use DisorderPsychiatric disorders | 7/98 | 4/106 |
| DepressionPsychiatric disorders | 2/98 | 4/106 |
| Gallbladder surgerySurgical and medical procedures | 2/98 | 0/106 |
| Chest PainCardiac disorders | 1/98 | 0/106 |
| AneursymVascular disorders | 1/98 | 0/106 |
| pneumoniaRespiratory, thoracic and mediastinal disorders | 1/98 | 0/106 |
| Shortness of BreathRespiratory, thoracic and mediastinal disorders | 0/98 | 1/106 |
| iron defficiencyBlood and lymphatic system disorders | 0/98 | 1/106 |
| Congestive Heart FailureCardiac disorders | 0/98 | 1/106 |
| Event | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) |
|---|---|---|
| upper respiratory infectionRespiratory, thoracic and mediastinal disorders | 5/98 | 6/106 |
| Back painMusculoskeletal and connective tissue disorders | 4/98 | 5/106 |
| urinary tract infectionInfections and infestations | 1/98 | 5/106 |
| DepressionPsychiatric disorders | 4/98 | 2/106 |
237 consented and screened individuals, 204 were randomized (n=98 to MM and n=106 to TAU)
| Age, Continuous(years) | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) | Total |
|---|---|---|---|
| Mean | 52.1 ± 9.8 | 54.2 ± 10 | 53.2 ± 9.9 |
| Sex: Female, Male(Participants) | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) | Total |
|---|---|---|---|
| Female | 6 | 6 | 12 |
| Male | 92 | 100 | 192 |
| Race (NIH/OMB)(Participants) | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 0 | 1 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 1 | 1 |
| Black or African American | 78 | 86 | 164 |
| White | 15 | 15 | 30 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 1 | 3 | 4 |
| Region of Enrollment(participants) | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) | Total |
|---|---|---|---|
| United States | 98 | 106 | 204 |
| Study Site(Participants) | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) | Total |
|---|---|---|---|
| Charleston SC VA | 58 | 62 | 120 |
| Birmingham AL VA | 40 | 44 | 84 |
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