Anxiety Disorder, Depression, Substance Abuse
Conditions
Keywords
substance abuse, Mental Health Disorders
Brief summary
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.
Detailed description
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.
Interventions
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.
BEHAVIORALTwelve-Step Facilitation Intervention (TSF)
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.
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
No masking
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Men and women military Veterans who have completed the Charleston or Tuscaloosa Veterans Administration Medical Center (VAMC) intensive outpatient substance abuse treatment program, a residential treatment program, or an intensive outpatient program similar to the Charleston or Tuscaloosa VAMC program. 2. Able to comprehend English. 3. Meets DSM-V criteria for a current substance use disorder and have used substances in the 30 days prior to treatment entry. Participants on medications targeting their substance use must be stabilized on medications for at least 2 weeks before therapy initiation. 4. May meet criteria for a mood, anxiety or other psychiatric disorder. Participants on maintenance medications for a mood or anxiety disorder must be stabilized on medications for at least 2 weeks before therapy initiation. 5. Able to adequately provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments. 6. Willing to commit to 8 group therapy sessions, baseline, weekly and follow-up assessments for 10-months after the end of treatment (12-month total).
Exclusion criteria
1. Active suicidal or homicidal ideation with a plan as this is likely to require hospitalization or other interventions that could interfere with study participation. 2. Unstable psychiatric condition likely to require hospitalization or other interventions that would interfere with study participation. 3. Unstable medical condition or one that may require hospitalization during the course of the study. 4. Meets criteria for nicotine dependence only 5. Women who are pregnant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Study Treatment Duration through 10 Months | 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. |
| Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Study Treatment Duration through 10 Months Follow up | 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. |
| Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Study Treatment Duration up to 8 Weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Beck Anxiety Inventory | Baseline, End of Treatment, 3 Months, 6 Months, 10 Months | 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. |
| Urine Drug Screen | Weekly, Week 8, 3 Months, 6 Months, 10 Months | 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. |
| EtG | Week 8, 3 Months, 6 Months, 10 Months | 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. |
| Days Engaging in Structured/Productive Work Activities (PWAC) | Weekly, Week 8, 3 Months, 6 Months, 10 Months | 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. |
| Treatment Engagement: Treatment Attendance Calendar (TAC) | Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months | 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. |
| Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months | 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. |
| Urine Drug Screen - End of Study | End of Study (up to 1 year) | 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. |
| Addiction Severity Index, Lite | 8 Weeks, 3 Months, 6 Months, 10 Months | 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). |
| Mindfulness Acceptance and Awareness Scale (MAAS) | Baseline, End of treatment, 3 Months, 6 Months, 10 Months | 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. |
| Beck Depression Inventory 2 | Baseline, End of Treatment, 3 Months, 6 Months, 10 Months | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| MINI-International Neuropsychiatric Interview | Baseline | 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. |
| Montreal Cognitive Assessment (MOCA) | Baseline | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Mindfulness Based Relapse Prevention (MBRP): Mindfulness Based Relapse Prevention (MBRP): 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). | 98 |
| Twelve-Step Facilitation Intervention (TSF) 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 (Brown et al., 2002). The eight selected sessions include four topics chosen by the manual developers as core topics and four elective topics. | 106 |
| Total | 204 |
Baseline characteristics
| Characteristic | Mindfulness Based Relapse Prevention (MBRP): | Twelve-Step Facilitation Intervention (TSF) | Total |
|---|---|---|---|
| Age, Continuous | 52.1 years STANDARD_DEVIATION 9.8 | 54.2 years STANDARD_DEVIATION 10 | 53.2 years STANDARD_DEVIATION 9.9 |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 78 Participants | 86 Participants | 164 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 4 Participants |
| Race (NIH/OMB) White | 15 Participants | 15 Participants | 30 Participants |
| Region of Enrollment United States | 98 participants | 106 participants | 204 participants |
| Sex: Female, Male Female | 6 Participants | 6 Participants | 12 Participants |
| Sex: Female, Male Male | 92 Participants | 100 Participants | 192 Participants |
| Study Site Birmingham AL VA | 40 Participants | 44 Participants | 84 Participants |
| Study Site Charleston SC VA | 58 Participants | 62 Participants | 120 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 98 | 1 / 106 |
| other Total, other adverse events | 14 / 98 | 18 / 106 |
| serious Total, serious adverse events | 14 / 98 | 15 / 106 |
Outcome results
Primary
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
Population: Any alcohol, binge alcohol or illicit substance use reported during study treatment through 10 months.~Available Data
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Any Alcohol Use | 25 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Any Binge Alcohol Use | 13 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Any Illicit Substance Use | 18 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Any Alcohol Use | 37 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Any Binge Alcohol Use | 20 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date | Any Illicit Substance Use | 29 Participants |
Primary
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
Population: participants randomized and reporting use/no with at least 1 treatment visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Any Alcohol Use During Study Treatment | 8 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Any Illicit Substance Use During Study Treatment | 9 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Cigarette Use During Study Treatment | 46 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Any Alcohol Use During Study Treatment | 12 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Any Illicit Substance Use During Study Treatment | 4 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Illicit Substance and Cigarette Use During Treatment up to 8 Weeks. Available Date | Cigarette Use During Study Treatment | 62 Participants |
Primary
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
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Relapse to any Alcohol Use | 110 Days to first relapse |
| Mindfulness Based Relapse Prevention (MBRP): | Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Relapse to Binge Alcohol Use | 95 Days to first relapse |
| Mindfulness Based Relapse Prevention (MBRP): | Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Relapse to any Illicit Substance Use | 1 Days to first relapse |
| Twelve-Step Facilitation Intervention (TSF) | Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Relapse to any Alcohol Use | 128 Days to first relapse |
| Twelve-Step Facilitation Intervention (TSF) | Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Relapse to Binge Alcohol Use | 196 Days to first relapse |
| Twelve-Step Facilitation Intervention (TSF) | Time to Relapse to Substance Use - Days to First Alcohol, Binge Alcohol and Illicit Substance Use. Available Data | Relapse to any Illicit Substance Use | 48 Days to first relapse |
Secondary
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
Population: some participants missed certain follow-ups.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Addiction Severity Index, Lite | 8 Weeks | .1186 score on a scale | Standard Error 0.1209 |
| Mindfulness Based Relapse Prevention (MBRP): | Addiction Severity Index, Lite | 3 Months | .1115 score on a scale | Standard Error 0.1651 |
| Mindfulness Based Relapse Prevention (MBRP): | Addiction Severity Index, Lite | 6 Months | .0764 score on a scale | Standard Error 0.1502 |
| Mindfulness Based Relapse Prevention (MBRP): | Addiction Severity Index, Lite | 10 Months | .0806 score on a scale | Standard Error 0.1215 |
| Twelve-Step Facilitation Intervention (TSF) | Addiction Severity Index, Lite | 10 Months | .1212 score on a scale | Standard Error 0.1428 |
| Twelve-Step Facilitation Intervention (TSF) | Addiction Severity Index, Lite | 8 Weeks | .1180 score on a scale | Standard Error 0.1368 |
| Twelve-Step Facilitation Intervention (TSF) | Addiction Severity Index, Lite | 6 Months | .1124 score on a scale | Standard Error 0.1721 |
| Twelve-Step Facilitation Intervention (TSF) | Addiction Severity Index, Lite | 3 Months | .0877 score on a scale | Standard Error 0.1452 |
Secondary
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
Population: data are reported as those available at study baseline and each subsequent study outcome time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Beck Anxiety Inventory | End of Treatment | 14.94 units on a scale | Standard Error 1.64 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Anxiety Inventory | 6 Months | 14.2 units on a scale | Standard Error 1.76 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Anxiety Inventory | 3 Months | 14.24 units on a scale | Standard Error 1.74 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Anxiety Inventory | 10 months | 14.15 units on a scale | Standard Error 1.72 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Anxiety Inventory | Baseline | 14.99 units on a scale | Standard Error 1.22 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Anxiety Inventory | 10 months | 12.90 units on a scale | Standard Error 1.91 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Anxiety Inventory | Baseline | 16.28 units on a scale | Standard Error 1.42 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Anxiety Inventory | End of Treatment | 11.09 units on a scale | Standard Error 1.65 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Anxiety Inventory | 3 Months | 10.46 units on a scale | Standard Error 1.8 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Anxiety Inventory | 6 Months | 11.40 units on a scale | Standard Error 1.53 |
Secondary
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
Population: data are reported as those available at study baseline and each subsequent study outcome time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Beck Depression Inventory 2 | End of Treatment | 8.96 units on a scale | Standard Error 1.12 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Depression Inventory 2 | 6 Months | 12.02 units on a scale | Standard Error 1.28 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Depression Inventory 2 | 3 Months | 11.75 units on a scale | Standard Error 1.28 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Depression Inventory 2 | 10 Months | 12.15 units on a scale | Standard Error 1.44 |
| Mindfulness Based Relapse Prevention (MBRP): | Beck Depression Inventory 2 | Baseline | 15.28 units on a scale | Standard Error 0.97 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Depression Inventory 2 | 10 Months | 9.17 units on a scale | Standard Error 1.33 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Depression Inventory 2 | Baseline | 14.26 units on a scale | Standard Error 0.95 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Depression Inventory 2 | End of Treatment | 7.02 units on a scale | Standard Error 0.97 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Depression Inventory 2 | 3 Months | 8.93 units on a scale | Standard Error 1.24 |
| Twelve-Step Facilitation Intervention (TSF) | Beck Depression Inventory 2 | 6 Months | 9.50 units on a scale | Standard Error 1.29 |
Secondary
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
Population: data are reported as those available at each study outcome time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 4 | 2 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 7 | 2 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 3 | 2 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 8 | 2.5 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 5 | 2 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | 3 Months | 5.5 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 2 | 0 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | 6 Months | 5 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 6 | 3 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | 10 Months | 0 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 1 | 1 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | 10 Months | 0 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 1 | 0 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 2 | 0 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 3 | 0 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 4 | 1 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 5 | 1 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 6 | 1 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 7 | 1 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | Week 8 | 1 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | 3 Months | 12 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Days Engaging in Structured/Productive Work Activities (PWAC) | 6 Months | 21.5 days reported |
Secondary
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
Population: Data listed as those with a positive EtG reading at each visit.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | EtG | Week 8 | 4 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | EtG | 3 Month | 3 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | EtG | 6 Month | 2 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | EtG | 10 Month | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | EtG | 10 Month | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | EtG | Week 8 | 9 Participants |
| Twelve-Step Facilitation Intervention (TSF) | EtG | 6 Month | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | EtG | 3 Month | 1 Participants |
Secondary
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
Population: data are reported as those available at study baseline and each subsequent study outcome time point.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Mindfulness Acceptance and Awareness Scale (MAAS) | End of Treatment | 4.04 units on a scale | Standard Error 0.12 |
| Mindfulness Based Relapse Prevention (MBRP): | Mindfulness Acceptance and Awareness Scale (MAAS) | 6 Months | 3.93 units on a scale | Standard Error 0.17 |
| Mindfulness Based Relapse Prevention (MBRP): | Mindfulness Acceptance and Awareness Scale (MAAS) | 3 Months | 4.10 units on a scale | Standard Error 0.14 |
| Mindfulness Based Relapse Prevention (MBRP): | Mindfulness Acceptance and Awareness Scale (MAAS) | 10 Months | 4.02 units on a scale | Standard Error 0.17 |
| Mindfulness Based Relapse Prevention (MBRP): | Mindfulness Acceptance and Awareness Scale (MAAS) | Baseline | 3.99 units on a scale | Standard Error 0.1 |
| Twelve-Step Facilitation Intervention (TSF) | Mindfulness Acceptance and Awareness Scale (MAAS) | 10 Months | 4.58 units on a scale | Standard Error 0.17 |
| Twelve-Step Facilitation Intervention (TSF) | Mindfulness Acceptance and Awareness Scale (MAAS) | Baseline | 4.12 units on a scale | Standard Error 0.1 |
| Twelve-Step Facilitation Intervention (TSF) | Mindfulness Acceptance and Awareness Scale (MAAS) | End of Treatment | 4.26 units on a scale | Standard Error 0.14 |
| Twelve-Step Facilitation Intervention (TSF) | Mindfulness Acceptance and Awareness Scale (MAAS) | 3 Months | 4.55 units on a scale | Standard Error 0.15 |
| Twelve-Step Facilitation Intervention (TSF) | Mindfulness Acceptance and Awareness Scale (MAAS) | 6 Months | 4.49 units on a scale | Standard Error 0.16 |
Secondary
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
Population: Total Quality of life data from available measures at study treatment conclusion and at study follow up visits.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | Week 8 | 75 units on a scale | Standard Deviation 16 |
| Mindfulness Based Relapse Prevention (MBRP): | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | 6 Months | 74 units on a scale | Standard Deviation 17 |
| Mindfulness Based Relapse Prevention (MBRP): | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | 3 Months | 75 units on a scale | Standard Deviation 15 |
| Mindfulness Based Relapse Prevention (MBRP): | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | 10 Months | 78 units on a scale | Standard Deviation 16 |
| Mindfulness Based Relapse Prevention (MBRP): | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | Baseline | 74 units on a scale | Standard Deviation 16 |
| Twelve-Step Facilitation Intervention (TSF) | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | 10 Months | 80 units on a scale | Standard Deviation 15 |
| Twelve-Step Facilitation Intervention (TSF) | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | Baseline | 73 units on a scale | Standard Deviation 18 |
| Twelve-Step Facilitation Intervention (TSF) | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | Week 8 | 81 units on a scale | Standard Deviation 17 |
| Twelve-Step Facilitation Intervention (TSF) | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | 3 Months | 80 units on a scale | Standard Deviation 19 |
| Twelve-Step Facilitation Intervention (TSF) | Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life. | 6 Months | 80 units on a scale | Standard Deviation 16 |
Secondary
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
Population: data are reported as those available at study baseline and each subsequent study outcome time point.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 4 | 3 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 7 | 3 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 3 | 3 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 8 | 3 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 5 | 4 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | 3 Months | 8.5 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 2 | 4 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | 6 Months | 4 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 6 | 4 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | 10 Months | 0 days reported |
| Mindfulness Based Relapse Prevention (MBRP): | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 1 | 6 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | 10 Months | 0 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 1 | 4 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 2 | 4 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 3 | 3 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 4 | 3 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 5 | 4 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 6 | 3 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 7 | 3 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | Week 8 | 3 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | 3 Months | 16 days reported |
| Twelve-Step Facilitation Intervention (TSF) | Treatment Engagement: Treatment Attendance Calendar (TAC) | 6 Months | 12 days reported |
Secondary
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
Population: Intent to Treat Sample of those with positive urine drug screens for THC
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 4 | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 7 | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 3 | 2 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 8 | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 5 | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | 3 Months | 3 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 2 | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | 6 Months | 2 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 6 | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | 10 Months | 8 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen | Week 1 | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | 10 Months | 6 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 1 | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 2 | 3 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 3 | 2 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 4 | 2 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 5 | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 6 | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 7 | 2 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | Week 8 | 3 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | 3 Months | 5 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen | 6 Months | 6 Participants |
Secondary
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)
Population: End of Study UDS results
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | OPI | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | AMP | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | PCP | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | BAR | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | MET | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | BZO | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | Coc | 10 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | OXY | 2 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | MTD | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | MDMA | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Urine Drug Screen - End of Study | THC | 8 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | MDMA | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | THC | 6 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | Coc | 7 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | PCP | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | OPI | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | MET | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | MTD | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | AMP | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | BAR | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | BZO | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Urine Drug Screen - End of Study | OXY | 0 Participants |
Other Pre-specified
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
Population: Baseline measure - all randomized participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Hypomanic Episode (Current) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | MDE (Past) | 49 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | MDD (Current) | 9 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | MDD (Past) | 37 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Manic Episode (Current) | 4 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Manic Episode (Past) | 7 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | MDE (Current) | 16 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Hypomanic Episode (Past) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Bipolar 1 (Current) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Bipolar 1 (Past) | 4 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Bipolar Unspec (Current) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Bipolar Unspec (Past) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Bipolar Unspec w/ Psych (Current) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Bipolar Unspec w/ Psych (Past) | 0 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Psychotic Disorder (Past Month) | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Psychotic Disorder (Lifetime) | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Mood Disorder w/ Psych (Current) | 1 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Mood Disorder w/ Psych (Lifetime) | 6 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Panic Disorder (Past Month) | 6 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Panic Disorder (Lifetime) | 10 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Agoraphobia (Current) | 16 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | Social Anxiety (Current) | 16 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | OCD (Current) | 4 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | PTSD (Current) | 25 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | AUD (Past 12 Mo) | 63 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | MINI-International Neuropsychiatric Interview | SUD (Past 12 Mo) | 67 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Panic Disorder (Lifetime) | 18 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | MDE (Current) | 10 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Bipolar Unspec w/ Psych (Past) | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | MDE (Past) | 51 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | AUD (Past 12 Mo) | 79 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | MDD (Current) | 6 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Psychotic Disorder (Past Month) | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | MDD (Past) | 35 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Agoraphobia (Current) | 11 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Manic Episode (Current) | 3 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Psychotic Disorder (Lifetime) | 7 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Manic Episode (Past) | 10 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | PTSD (Current) | 23 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Hypomanic Episode (Current) | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Mood Disorder w/ Psych (Current) | 1 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Hypomanic Episode (Past) | 3 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Social Anxiety (Current) | 12 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Bipolar 1 (Current) | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Mood Disorder w/ Psych (Lifetime) | 5 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Bipolar 1 (Past) | 7 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | SUD (Past 12 Mo) | 74 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Bipolar Unspec (Current) | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Panic Disorder (Past Month) | 13 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Bipolar Unspec (Past) | 0 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | OCD (Current) | 3 Participants |
| Twelve-Step Facilitation Intervention (TSF) | MINI-International Neuropsychiatric Interview | Bipolar Unspec w/ Psych (Current) | 0 Participants |
Other Pre-specified
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
Population: Baseline Measure - all randomized participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Montreal Cognitive Assessment (MOCA) | 25.8 units on a scale | Standard Deviation 2.6 |
| Twelve-Step Facilitation Intervention (TSF) | Montreal Cognitive Assessment (MOCA) | 25.9 units on a scale | Standard Deviation 2.9 |
Post Hoc
Study Visit Attendance
Weekly study visit and follow-up visit attendance
Time frame: Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months
Population: all randomized participants
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 4 | 51 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 7 | 39 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 3 | 59 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 8 | 51 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 5 | 55 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | 3 Months | 50 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 2 | 68 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | 6 Months | 46 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 6 | 49 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | 10 Months | 47 Participants |
| Mindfulness Based Relapse Prevention (MBRP): | Study Visit Attendance | Week 1 | 69 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | 10 Months | 50 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 1 | 93 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 2 | 77 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 3 | 76 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 4 | 68 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 5 | 65 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 6 | 61 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 7 | 61 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | Week 8 | 67 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | 3 Months | 55 Participants |
| Twelve-Step Facilitation Intervention (TSF) | Study Visit Attendance | 6 Months | 50 Participants |