Trial Outcomes & Findings for Mindfulness-Based Recovery in Veterans (NCT NCT02326363)
NCT ID: NCT02326363
Last Updated: 2021-02-10
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
204 participants
Primary outcome timeframe
Study Treatment Duration up to 8 Weeks
Results posted on
2021-02-10
Participant Flow
Participant milestones
| Measure |
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).
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
98
|
106
|
|
Overall Study
COMPLETED
|
47
|
50
|
|
Overall Study
NOT COMPLETED
|
51
|
56
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mindfulness-Based Recovery in Veterans
Baseline characteristics by cohort
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
Total
n=204 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.1 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
54.2 years
STANDARD_DEVIATION 10 • n=7 Participants
|
53.2 years
STANDARD_DEVIATION 9.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
92 Participants
n=5 Participants
|
100 Participants
n=7 Participants
|
192 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
78 Participants
n=5 Participants
|
86 Participants
n=7 Participants
|
164 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
98 participants
n=5 Participants
|
106 participants
n=7 Participants
|
204 participants
n=5 Participants
|
|
Study Site
Charleston SC VA
|
58 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Study Site
Birmingham AL VA
|
40 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
84 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Study Treatment Duration up to 8 WeeksPopulation: participants randomized and reporting use/no with at least 1 treatment visit.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=74 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=87 Participants
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.
|
|---|---|---|
|
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
|
12 Participants
|
|
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
|
4 Participants
|
|
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
|
62 Participants
|
PRIMARY outcome
Timeframe: Study Treatment Duration through 10 Months Follow upPopulation: Any alcohol, binge alcohol or illicit substance use reported during study treatment through 10 months. 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 (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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date
Any Alcohol Use
|
25 Participants
|
37 Participants
|
|
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date
Any Binge Alcohol Use
|
13 Participants
|
20 Participants
|
|
Timeline Follow-Back (TLFB) - Number of Participants With Alcohol, Binge Alcohol, Illicit Drug Use. Available Date
Any Illicit Substance Use
|
18 Participants
|
29 Participants
|
PRIMARY outcome
Timeframe: Study Treatment Duration through 10 MonthsThe 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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
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
Interval 74.0 to 138.0
|
128 Days to first relapse
Interval 45.0 to 195.0
|
|
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
Interval 78.0 to 135.0
|
196 Days to first relapse
Interval 94.0 to 298.0
|
|
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
Interval 1.0 to 265.0
|
48 Days to first relapse
Interval 1.0 to 293.0
|
SECONDARY outcome
Timeframe: Baseline, End of treatment, 3 Months, 6 Months, 10 MonthsPopulation: data are reported as those available at study baseline and each subsequent study outcome time point.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Mindfulness Acceptance and Awareness Scale (MAAS)
3 Months
|
4.10 units on a scale
Standard Error 0.14
|
4.55 units on a scale
Standard Error 0.15
|
|
Mindfulness Acceptance and Awareness Scale (MAAS)
6 Months
|
3.93 units on a scale
Standard Error 0.17
|
4.49 units on a scale
Standard Error 0.16
|
|
Mindfulness Acceptance and Awareness Scale (MAAS)
10 Months
|
4.02 units on a scale
Standard Error 0.17
|
4.58 units on a scale
Standard Error 0.17
|
|
Mindfulness Acceptance and Awareness Scale (MAAS)
Baseline
|
3.99 units on a scale
Standard Error 0.10
|
4.12 units on a scale
Standard Error 0.1
|
|
Mindfulness Acceptance and Awareness Scale (MAAS)
End of Treatment
|
4.04 units on a scale
Standard Error 0.12
|
4.26 units on a scale
Standard Error 0.14
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment, 3 Months, 6 Months, 10 MonthsPopulation: data are reported as those available at study baseline and each subsequent study outcome time point.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Beck Depression Inventory 2
Baseline
|
15.28 units on a scale
Standard Error 0.97
|
14.26 units on a scale
Standard Error 0.95
|
|
Beck Depression Inventory 2
End of Treatment
|
8.96 units on a scale
Standard Error 1.12
|
7.02 units on a scale
Standard Error 0.97
|
|
Beck Depression Inventory 2
3 Months
|
11.75 units on a scale
Standard Error 1.28
|
8.93 units on a scale
Standard Error 1.24
|
|
Beck Depression Inventory 2
6 Months
|
12.02 units on a scale
Standard Error 1.28
|
9.50 units on a scale
Standard Error 1.29
|
|
Beck Depression Inventory 2
10 Months
|
12.15 units on a scale
Standard Error 1.44
|
9.17 units on a scale
Standard Error 1.33
|
SECONDARY outcome
Timeframe: Baseline, End of Treatment, 3 Months, 6 Months, 10 MonthsPopulation: data are reported as those available at study baseline and each subsequent study outcome time point.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Beck Anxiety Inventory
Baseline
|
14.99 units on a scale
Standard Error 1.22
|
16.28 units on a scale
Standard Error 1.42
|
|
Beck Anxiety Inventory
End of Treatment
|
14.94 units on a scale
Standard Error 1.64
|
11.09 units on a scale
Standard Error 1.65
|
|
Beck Anxiety Inventory
3 Months
|
14.24 units on a scale
Standard Error 1.74
|
10.46 units on a scale
Standard Error 1.8
|
|
Beck Anxiety Inventory
6 Months
|
14.2 units on a scale
Standard Error 1.76
|
11.40 units on a scale
Standard Error 1.53
|
|
Beck Anxiety Inventory
10 months
|
14.15 units on a scale
Standard Error 1.72
|
12.90 units on a scale
Standard Error 1.91
|
SECONDARY outcome
Timeframe: Weekly, Week 8, 3 Months, 6 Months, 10 MonthsPopulation: Intent to Treat Sample of those with positive urine drug screens for THC
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Urine Drug Screen
Week 8
|
0 Participants
|
3 Participants
|
|
Urine Drug Screen
6 Months
|
2 Participants
|
6 Participants
|
|
Urine Drug Screen
10 Months
|
8 Participants
|
6 Participants
|
|
Urine Drug Screen
3 Months
|
3 Participants
|
5 Participants
|
|
Urine Drug Screen
Week 1
|
0 Participants
|
0 Participants
|
|
Urine Drug Screen
Week 2
|
1 Participants
|
3 Participants
|
|
Urine Drug Screen
Week 3
|
2 Participants
|
2 Participants
|
|
Urine Drug Screen
Week 4
|
0 Participants
|
2 Participants
|
|
Urine Drug Screen
Week 5
|
0 Participants
|
1 Participants
|
|
Urine Drug Screen
Week 6
|
0 Participants
|
1 Participants
|
|
Urine Drug Screen
Week 7
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Week 8, 3 Months, 6 Months, 10 MonthsPopulation: Data listed as those with a positive EtG reading at each visit.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
EtG
Week 8
|
4 Participants
|
9 Participants
|
|
EtG
3 Month
|
3 Participants
|
1 Participants
|
|
EtG
6 Month
|
2 Participants
|
1 Participants
|
|
EtG
10 Month
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 8 Weeks, 3 Months, 6 Months, 10 MonthsPopulation: some participants missed certain follow-ups.
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).
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=52 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=65 Participants
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.
|
|---|---|---|
|
Addiction Severity Index, Lite
8 Weeks
|
.1186 score on a scale
Standard Error .1209
|
.1180 score on a scale
Standard Error .1368
|
|
Addiction Severity Index, Lite
3 Months
|
.1115 score on a scale
Standard Error .1651
|
.0877 score on a scale
Standard Error .1452
|
|
Addiction Severity Index, Lite
6 Months
|
.0764 score on a scale
Standard Error .1502
|
.1124 score on a scale
Standard Error .1721
|
|
Addiction Severity Index, Lite
10 Months
|
.0806 score on a scale
Standard Error .1215
|
.1212 score on a scale
Standard Error .1428
|
SECONDARY outcome
Timeframe: Weekly, Week 8, 3 Months, 6 Months, 10 MonthsPopulation: data are reported as those available at each study outcome time point.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 1
|
1 days reported
Interval 0.0 to 4.0
|
0 days reported
Interval 0.0 to 3.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 2
|
0 days reported
Interval 0.0 to 5.0
|
0 days reported
Interval 0.0 to 3.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 3
|
2 days reported
Interval 0.0 to 6.0
|
0 days reported
Interval 0.0 to 3.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 4
|
2 days reported
Interval 0.0 to 6.0
|
1 days reported
Interval 0.0 to 5.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 5
|
2 days reported
Interval 0.0 to 7.0
|
1 days reported
Interval 0.0 to 5.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 6
|
3 days reported
Interval 0.0 to 6.0
|
1 days reported
Interval 0.0 to 5.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 7
|
2 days reported
Interval 0.0 to 6.0
|
1 days reported
Interval 0.0 to 5.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
Week 8
|
2.5 days reported
Interval 0.0 to 7.0
|
1 days reported
Interval 0.0 to 7.5
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
3 Months
|
5.5 days reported
Interval 0.0 to 51.5
|
12 days reported
Interval 0.0 to 49.0
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
6 Months
|
5 days reported
Interval 0.0 to 60.0
|
21.5 days reported
Interval 0.0 to 54.5
|
|
Days Engaging in Structured/Productive Work Activities (PWAC)
10 Months
|
0 days reported
Interval 0.0 to 8.0
|
0 days reported
Interval 0.0 to 15.0
|
SECONDARY outcome
Timeframe: Weekly, 8 Weeks, 3 Months, 6 Months, 10 MonthsPopulation: data are reported as those available at study baseline and each subsequent study outcome time point.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 7
|
3 days reported
Interval 1.0 to 4.0
|
3 days reported
Interval 1.0 to 6.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 1
|
6 days reported
Interval 0.0 to 13.0
|
4 days reported
Interval 1.0 to 9.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 2
|
4 days reported
Interval 1.0 to 7.0
|
4 days reported
Interval 1.0 to 6.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 3
|
3 days reported
Interval 1.0 to 7.0
|
3 days reported
Interval 1.0 to 7.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 4
|
3 days reported
Interval 0.0 to 8.0
|
3 days reported
Interval 2.0 to 6.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 5
|
4 days reported
Interval 1.0 to 7.0
|
4 days reported
Interval 2.0 to 7.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 6
|
4 days reported
Interval 1.0 to 6.0
|
3 days reported
Interval 1.0 to 6.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
Week 8
|
3 days reported
Interval 0.0 to 6.0
|
3 days reported
Interval 1.0 to 6.5
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
3 Months
|
8.5 days reported
Interval 1.5 to 42.0
|
16 days reported
Interval 3.0 to 45.0
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
6 Months
|
4 days reported
Interval 0.0 to 26.0
|
12 days reported
Interval 2.0 to 34.5
|
|
Treatment Engagement: Treatment Attendance Calendar (TAC)
10 Months
|
0 days reported
Interval 0.0 to 8.0
|
0 days reported
Interval 0.0 to 10.0
|
SECONDARY outcome
Timeframe: Baseline, 8 Weeks, 3 Months, 6 Months, 10 MonthsPopulation: Total Quality of life data from available measures at study treatment conclusion and at study follow up visits.
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
Baseline
|
74 units on a scale
Standard Deviation 16
|
73 units on a scale
Standard Deviation 18
|
|
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
Week 8
|
75 units on a scale
Standard Deviation 16
|
81 units on a scale
Standard Deviation 17
|
|
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
3 Months
|
75 units on a scale
Standard Deviation 15
|
80 units on a scale
Standard Deviation 19
|
|
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
6 Months
|
74 units on a scale
Standard Deviation 17
|
80 units on a scale
Standard Deviation 16
|
|
Quality of Life Scale (QOLS) is a 16 Item Scale Measuring Quality of Life.
10 Months
|
78 units on a scale
Standard Deviation 16
|
80 units on a scale
Standard Deviation 15
|
SECONDARY outcome
Timeframe: End of Study (up to 1 year)Population: End of Study UDS results
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Urine Drug Screen - End of Study
THC
|
8 Participants
|
6 Participants
|
|
Urine Drug Screen - End of Study
Coc
|
10 Participants
|
7 Participants
|
|
Urine Drug Screen - End of Study
PCP
|
0 Participants
|
1 Participants
|
|
Urine Drug Screen - End of Study
OPI
|
0 Participants
|
1 Participants
|
|
Urine Drug Screen - End of Study
MET
|
1 Participants
|
0 Participants
|
|
Urine Drug Screen - End of Study
MTD
|
1 Participants
|
0 Participants
|
|
Urine Drug Screen - End of Study
AMP
|
1 Participants
|
0 Participants
|
|
Urine Drug Screen - End of Study
BAR
|
1 Participants
|
0 Participants
|
|
Urine Drug Screen - End of Study
BZO
|
0 Participants
|
1 Participants
|
|
Urine Drug Screen - End of Study
OXY
|
2 Participants
|
0 Participants
|
|
Urine Drug Screen - End of Study
MDMA
|
0 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Baseline measure - all randomized participants
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
MINI-International Neuropsychiatric Interview
MDE (Current)
|
16 Participants
|
10 Participants
|
|
MINI-International Neuropsychiatric Interview
MDE (Past)
|
49 Participants
|
51 Participants
|
|
MINI-International Neuropsychiatric Interview
MDD (Current)
|
9 Participants
|
6 Participants
|
|
MINI-International Neuropsychiatric Interview
MDD (Past)
|
37 Participants
|
35 Participants
|
|
MINI-International Neuropsychiatric Interview
Manic Episode (Current)
|
4 Participants
|
3 Participants
|
|
MINI-International Neuropsychiatric Interview
Manic Episode (Past)
|
7 Participants
|
10 Participants
|
|
MINI-International Neuropsychiatric Interview
Hypomanic Episode (Current)
|
0 Participants
|
0 Participants
|
|
MINI-International Neuropsychiatric Interview
Hypomanic Episode (Past)
|
0 Participants
|
3 Participants
|
|
MINI-International Neuropsychiatric Interview
Bipolar 1 (Current)
|
0 Participants
|
0 Participants
|
|
MINI-International Neuropsychiatric Interview
Bipolar 1 (Past)
|
4 Participants
|
7 Participants
|
|
MINI-International Neuropsychiatric Interview
Bipolar Unspec (Current)
|
0 Participants
|
0 Participants
|
|
MINI-International Neuropsychiatric Interview
Bipolar Unspec (Past)
|
0 Participants
|
0 Participants
|
|
MINI-International Neuropsychiatric Interview
Bipolar Unspec w/ Psych (Current)
|
0 Participants
|
0 Participants
|
|
MINI-International Neuropsychiatric Interview
Bipolar Unspec w/ Psych (Past)
|
0 Participants
|
1 Participants
|
|
MINI-International Neuropsychiatric Interview
Psychotic Disorder (Past Month)
|
1 Participants
|
1 Participants
|
|
MINI-International Neuropsychiatric Interview
Psychotic Disorder (Lifetime)
|
1 Participants
|
7 Participants
|
|
MINI-International Neuropsychiatric Interview
Mood Disorder w/ Psych (Current)
|
1 Participants
|
1 Participants
|
|
MINI-International Neuropsychiatric Interview
Mood Disorder w/ Psych (Lifetime)
|
6 Participants
|
5 Participants
|
|
MINI-International Neuropsychiatric Interview
Panic Disorder (Past Month)
|
6 Participants
|
13 Participants
|
|
MINI-International Neuropsychiatric Interview
Panic Disorder (Lifetime)
|
10 Participants
|
18 Participants
|
|
MINI-International Neuropsychiatric Interview
Agoraphobia (Current)
|
16 Participants
|
11 Participants
|
|
MINI-International Neuropsychiatric Interview
Social Anxiety (Current)
|
16 Participants
|
12 Participants
|
|
MINI-International Neuropsychiatric Interview
OCD (Current)
|
4 Participants
|
3 Participants
|
|
MINI-International Neuropsychiatric Interview
PTSD (Current)
|
25 Participants
|
23 Participants
|
|
MINI-International Neuropsychiatric Interview
AUD (Past 12 Mo)
|
63 Participants
|
79 Participants
|
|
MINI-International Neuropsychiatric Interview
SUD (Past 12 Mo)
|
67 Participants
|
74 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: BaselinePopulation: Baseline Measure - all randomized participants
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.
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Montreal Cognitive Assessment (MOCA)
|
25.8 units on a scale
Standard Deviation 2.6
|
25.9 units on a scale
Standard Deviation 2.9
|
POST_HOC outcome
Timeframe: Weekly, 8 Weeks, 3 Months, 6 Months, 10 MonthsPopulation: all randomized participants
Weekly study visit and follow-up visit attendance
Outcome measures
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 Participants
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 Participants
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.
|
|---|---|---|
|
Study Visit Attendance
Week 3
|
59 Participants
|
76 Participants
|
|
Study Visit Attendance
Week 4
|
51 Participants
|
68 Participants
|
|
Study Visit Attendance
Week 5
|
55 Participants
|
65 Participants
|
|
Study Visit Attendance
Week 6
|
49 Participants
|
61 Participants
|
|
Study Visit Attendance
Week 7
|
39 Participants
|
61 Participants
|
|
Study Visit Attendance
Week 8
|
51 Participants
|
67 Participants
|
|
Study Visit Attendance
3 Months
|
50 Participants
|
55 Participants
|
|
Study Visit Attendance
6 Months
|
46 Participants
|
50 Participants
|
|
Study Visit Attendance
10 Months
|
47 Participants
|
50 Participants
|
|
Study Visit Attendance
Week 1
|
69 Participants
|
93 Participants
|
|
Study Visit Attendance
Week 2
|
68 Participants
|
77 Participants
|
Adverse Events
Mindfulness Based Relapse Prevention (MBRP):
Serious events: 14 serious events
Other events: 14 other events
Deaths: 1 deaths
Twelve-Step Facilitation Intervention (TSF)
Serious events: 15 serious events
Other events: 18 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 participants at risk
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Relapse to Substance Use Disorder
|
7.1%
7/98 • Number of events 7 • 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.
|
3.8%
4/106 • Number of events 4 • 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.
|
|
Psychiatric disorders
Depression
|
2.0%
2/98 • Number of events 4 • 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.
|
3.8%
4/106 • Number of events 4 • 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.
|
|
Surgical and medical procedures
Gallbladder surgery
|
2.0%
2/98 • Number of events 2 • 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.
|
0.00%
0/106 • 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.
|
|
Surgical and medical procedures
Hernia surgery
|
0.00%
0/98 • 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.
|
100.0%
1/1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of Breath
|
0.00%
0/98 • 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.
|
0.94%
1/106 • Number of events 1 • 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.
|
|
Cardiac disorders
Chest Pain
|
1.0%
1/98 • Number of events 1 • 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.
|
0.00%
0/106 • 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.
|
|
Blood and lymphatic system disorders
iron defficiency
|
0.00%
0/98 • 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.
|
0.94%
1/106 • Number of events 1 • 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.
|
|
Cardiac disorders
Congestive Heart Failure
|
0.00%
0/98 • 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.
|
0.94%
1/106 • Number of events 1 • 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.
|
|
Eye disorders
Occipital Fracture
|
0.00%
0/98 • 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.
|
0.94%
1/106 • Number of events 1 • 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.
|
|
Vascular disorders
Aneursym
|
1.0%
1/98 • Number of events 1 • 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.
|
0.00%
0/106 • 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.
|
|
Psychiatric disorders
Homicidal Ideation
|
0.00%
0/98 • 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.
|
0.94%
1/106 • Number of events 1 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
1.0%
1/98 • Number of events 1 • 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.
|
0.00%
0/106 • 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.
|
|
Psychiatric disorders
psychosis
|
0.00%
0/98 • 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.
|
0.94%
1/106 • Number of events 1 • 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.
|
Other adverse events
| Measure |
Mindfulness Based Relapse Prevention (MBRP):
n=98 participants at risk
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).
|
Twelve-Step Facilitation Intervention (TSF)
n=106 participants at risk
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.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
4.1%
4/98 • Number of events 4 • 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.
|
4.7%
5/106 • Number of events 5 • 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.
|
|
Infections and infestations
urinary tract infection
|
1.0%
1/98 • Number of events 1 • 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.
|
4.7%
5/106 • Number of events 5 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
5.1%
5/98 • Number of events 5 • 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.
|
5.7%
6/106 • Number of events 6 • 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.
|
|
Psychiatric disorders
Depression
|
4.1%
4/98 • Number of events 4 • 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.
|
1.9%
2/106 • Number of events 2 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place