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| ID | Type | Description | Link |
|---|---|---|---|
| I01RX001292 | U.S. NIH Grant/Contract | View source |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP): | Experimental | 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. |
|
| Twelve-Step Facilitation Intervention (TSF) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mindfulness Based Relapse Prevention (MBRP) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | Study Treatment Duration through 10 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, End of treatment, 3 Months, 6 Months, 10 Months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kathleen Theresa Brady, MD PhD | Ralph H. Johnson VA Medical Center, Charleston, SC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tuscaloosa VA Medical Center, Tuscaloosa, AL | Tuscaloosa | Alabama | 35404 | United States | ||
| Ralph H. Johnson VA Medical Center, Charleston, SC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37364669 | Derived | Killeen TK, Baker NL, Davis LL, Bowen S, Brady KT. Efficacy of mindfulness-based relapse prevention in a sample of veterans in a substance use disorder aftercare program: A randomized controlled trial. J Subst Use Addict Treat. 2023 Sep;152:209116. doi: 10.1016/j.josat.2023.209116. Epub 2023 Jun 25. | |
| 33857680 | Derived | Brady KT, Killeen T, Baker NL. Efficacy of mindfulness-based relapse prevention in veterans with substance use disorders: Design and methodology of a randomized clinical trial. Contemp Clin Trials. 2021 Jun;105:106393. doi: 10.1016/j.cct.2021.106393. Epub 2021 Apr 20. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
237 consented and screened individuals, 204 were randomized (n=98 to MM and n=106 to TAU)
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | participants randomized and reporting use/no with at least 1 treatment visit. | Posted | Count of Participants | Participants | Study Treatment Duration up to 8 Weeks |
|
Study treatment, 8 weeks, follow-up, up to 10 months
Any untoward or unfavorable medical occurrence in a participant, including any abnormal sign symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected by self report assessment at baseline, weekly over the 8 week intervention, end of treatment and 3-, 6- and 10 months follow-up periods.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Relapse to Substance Use Disorder | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (10.0) | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Nathaniel L Baker | Medical University of South Carolina | 843-792-5028 | bakern@musc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 26, 2016 | May 15, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 1, 2016 | May 15, 2020 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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No masking
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|
| Twelve-Step Facilitation Intervention (TSF) | Behavioral | 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. |
|
| 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. | 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. | 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. | 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. | 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). | 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. | 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. | 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. | 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. | End of Study (up to 1 year) |
| 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. | Baseline |
| Charleston |
| South Carolina |
| 29401-5799 |
| United States |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Study Site | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| 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. | Any alcohol, binge alcohol or illicit substance use reported during study treatment through 10 months. Available Data | Posted | Count of Participants | Participants | Study Treatment Duration through 10 Months Follow up |
|
|
|
| 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. | Posted | Median | Inter-Quartile Range | Days to first relapse | Study Treatment Duration through 10 Months |
|
|
|
| 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. | data are reported as those available at study baseline and each subsequent study outcome time point. | Posted | Mean | Standard Error | units on a scale | Baseline, End of treatment, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | data are reported as those available at study baseline and each subsequent study outcome time point. | Posted | Mean | Standard Error | units on a scale | Baseline, End of Treatment, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | data are reported as those available at study baseline and each subsequent study outcome time point. | Posted | Mean | Standard Error | units on a scale | Baseline, End of Treatment, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | Intent to Treat Sample of those with positive urine drug screens for THC | Posted | Count of Participants | Participants | Weekly, Week 8, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | Data listed as those with a positive EtG reading at each visit. | Posted | Count of Participants | Participants | Week 8, 3 Months, 6 Months, 10 Months |
|
|
|
| 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). | some participants missed certain follow-ups. | Posted | Mean | Standard Error | score on a scale | 8 Weeks, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | data are reported as those available at each study outcome time point. | Posted | Median | Inter-Quartile Range | days reported | Weekly, Week 8, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | data are reported as those available at study baseline and each subsequent study outcome time point. | Posted | Median | Inter-Quartile Range | days reported | Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | Total Quality of life data from available measures at study treatment conclusion and at study follow up visits. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 8 Weeks, 3 Months, 6 Months, 10 Months |
|
|
|
| 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. | End of Study UDS results | Posted | Count of Participants | Participants | End of Study (up to 1 year) |
|
|
|
| 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. | Baseline measure - all randomized participants | Posted | Count of Participants | Participants | Baseline |
|
|
|
| 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. | Baseline Measure - all randomized participants | Posted | Mean | Standard Deviation | units on a scale | Baseline |
|
|
|
| Post-Hoc | Study Visit Attendance | Weekly study visit and follow-up visit attendance | all randomized participants | Posted | Count of Participants | Participants | Weekly, 8 Weeks, 3 Months, 6 Months, 10 Months |
|
|
|
| 1 |
| 98 |
| 14 |
| 98 |
| 14 |
| 98 |
| EG001 | 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. | 1 | 106 | 15 | 106 | 18 | 106 |
| Depression | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Gallbladder surgery | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Hernia surgery | Surgical and medical procedures | MedDRA (10.0) | Non-systematic Assessment |
|
| Shortness of Breath | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Chest Pain | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| iron defficiency | Blood and lymphatic system disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Congestive Heart Failure | Cardiac disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Occipital Fracture | Eye disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Aneursym | Vascular disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Homicidal Ideation | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| pneumonia | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| psychosis | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| urinary tract infection | Infections and infestations | MedDRA (10.0) | Non-systematic Assessment |
|
| upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (10.0) | Non-systematic Assessment |
|
| Depression | Psychiatric disorders | MedDRA (10.0) | Non-systematic Assessment |
|
Not provided
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| Any Illicit Substance Use |
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| Relapse to any Illicit Substance Use |
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| End of Treatment |
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| MET |
|
|
| MTD |
|
|
| AMP |
|
|
| BAR |
|
|
| BZO |
|
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| OXY |
|
|
| MDMA |
|
|
| MDD (Current) |
|
| MDD (Past) |
|
| Manic Episode (Current) |
|
| Manic Episode (Past) |
|
| Hypomanic Episode (Current) |
|
| Hypomanic Episode (Past) |
|
| Bipolar 1 (Current) |
|
| Bipolar 1 (Past) |
|
| Bipolar Unspec (Current) |
|
| Bipolar Unspec (Past) |
|
| Bipolar Unspec w/ Psych (Current) |
|
| Bipolar Unspec w/ Psych (Past) |
|
| Psychotic Disorder (Past Month) |
|
| Psychotic Disorder (Lifetime) |
|
| Mood Disorder w/ Psych (Current) |
|
| Mood Disorder w/ Psych (Lifetime) |
|
| Panic Disorder (Past Month) |
|
| Panic Disorder (Lifetime) |
|
| Agoraphobia (Current) |
|
| Social Anxiety (Current) |
|
| OCD (Current) |
|
| PTSD (Current) |
|
| AUD (Past 12 Mo) |
|
| SUD (Past 12 Mo) |
|
| Week 3 |
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| Week 4 |
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| Week 5 |
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| Week 6 |
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| Week 7 |
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| Week 8 |
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| 3 Months |
|
| 6 Months |
|
| 10 Months |
|