Trial Outcomes & Findings for Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II Trial (NCT NCT01318538)

Last Updated: 2017-06-05

Results Overview

This represents the percent change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol) for women. Days of substance use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean days of any substance use. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.

Recruitment status

COMPLETED

Study phase

Target enrollment

158 participants

Primary outcome timeframe

In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Results posted on

2017-06-05

Participant Flow

Subjects were recruited at McLean Hospital in Belmont, MA and SSTAR Inc. in Fall River, MA using advertisements, flyers, and clinician referrals. At both sites, subjects were recruited from inpatient, residential, partial hospital and outpatient programs. Those recruited from inpatient or residential settings started the groups after discharge.

Group therapists provided feedback about the groups that they ran, but were not technically enrolled in the study and therefore are not included in initial enrollment number.

Participant milestones

Participant milestones
Measure	Women's Recovery Group The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.	Group Therapist Therapists who ran and led the group sessions for both the single-gender Women's Recovery Group and mixed-gender Group Drug Counseling.
Overall Study STARTED	52	106	8
Overall Study COMPLETED	52	106	8
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Women's Recovery Group (WRG) Study - A Randomized Controlled Stage II Trial

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=106 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. NOTE: Baseline characteristics reported in Table Below reflect all participants including men assigned to the GDC condition. Analysis of data for study specific aims include only women randomized to WRG (N=52) and GDC (N=48).	Total n=158 Participants Total of all reporting groups
Age, Continuous	45.7 Years STANDARD_DEVIATION 12.6 • n=5 Participants	47.6 Years STANDARD_DEVIATION 12.0 • n=7 Participants	47 Years STANDARD_DEVIATION 12.2 • n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants	48 Participants n=7 Participants	100 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	58 Participants n=7 Participants	58 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	52 Participants n=5 Participants	105 Participants n=7 Participants	157 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	5 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) White	48 Participants n=5 Participants	101 Participants n=7 Participants	149 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Marital Status Married	19 participants n=5 Participants	41 participants n=7 Participants	60 participants n=5 Participants
Marital Status Divorced/Separated	17 participants n=5 Participants	27 participants n=7 Participants	44 participants n=5 Participants
Marital Status Never married	12 participants n=5 Participants	30 participants n=7 Participants	42 participants n=5 Participants
Marital Status Unmarried and living with partner	4 participants n=5 Participants	5 participants n=7 Participants	9 participants n=5 Participants
Marital Status Widowed	0 participants n=5 Participants	3 participants n=7 Participants	3 participants n=5 Participants
Education Did not graduate high school	4 participants n=5 Participants	7 participants n=7 Participants	11 participants n=5 Participants
Education Graduated high school	7 participants n=5 Participants	22 participants n=7 Participants	29 participants n=5 Participants
Education Some college	11 participants n=5 Participants	22 participants n=7 Participants	33 participants n=5 Participants
Education Graduated from college	18 participants n=5 Participants	34 participants n=7 Participants	52 participants n=5 Participants
Education Postgraduate	12 participants n=5 Participants	21 participants n=7 Participants	33 participants n=5 Participants
Household Income $0-$20,000	17 participants n=5 Participants	26 participants n=7 Participants	43 participants n=5 Participants
Household Income $20,001-$50,000	9 participants n=5 Participants	31 participants n=7 Participants	40 participants n=5 Participants
Household Income $50,001-$100,000	11 participants n=5 Participants	28 participants n=7 Participants	39 participants n=5 Participants
Household Income More than $100,000	15 participants n=5 Participants	21 participants n=7 Participants	36 participants n=5 Participants
Current psychiatric diagnoses Major depressive disorder	30 participants n=5 Participants	58 participants n=7 Participants	88 participants n=5 Participants
Current psychiatric diagnoses Generalized anxiety disorder	11 participants n=5 Participants	20 participants n=7 Participants	31 participants n=5 Participants
Current psychiatric diagnoses Post-traumatic stress disorder	9 participants n=5 Participants	20 participants n=7 Participants	29 participants n=5 Participants
Current psychiatric diagnoses Any Axis I	37 participants n=5 Participants	79 participants n=7 Participants	116 participants n=5 Participants
Current psychiatric diagnoses Any Axis II	9 participants n=5 Participants	15 participants n=7 Participants	24 participants n=5 Participants
Substance use diagnoses Alcohol current	43 participants n=5 Participants	97 participants n=7 Participants	140 participants n=5 Participants
Substance use diagnoses Alcohol lifetime	45 participants n=5 Participants	101 participants n=7 Participants	146 participants n=5 Participants
Substance use diagnoses Cocaine current	8 participants n=5 Participants	20 participants n=7 Participants	28 participants n=5 Participants
Substance use diagnoses Cocaine lifetime	17 participants n=5 Participants	40 participants n=7 Participants	57 participants n=5 Participants
Substance use diagnoses Cannabis current	3 participants n=5 Participants	16 participants n=7 Participants	19 participants n=5 Participants
Substance use diagnoses Cannabis lifetime	7 participants n=5 Participants	27 participants n=7 Participants	34 participants n=5 Participants
Substance use diagnoses Opioids current	7 participants n=5 Participants	19 participants n=7 Participants	26 participants n=5 Participants
Substance use diagnoses Opioids lifetime	13 participants n=5 Participants	27 participants n=7 Participants	40 participants n=5 Participants
Substance use diagnoses Sedatives current	5 participants n=5 Participants	11 participants n=7 Participants	16 participants n=5 Participants
Substance use diagnoses Sedatives lifetime	5 participants n=5 Participants	17 participants n=7 Participants	22 participants n=5 Participants
Substance use days (past 30 days) Alcohol use days	12.7 Days STANDARD_DEVIATION 9.9 • n=5 Participants	15.4 Days STANDARD_DEVIATION 10.5 • n=7 Participants	14.6 Days STANDARD_DEVIATION 10.3 • n=5 Participants
Substance use days (past 30 days) Days of any substance use (including alcohol)	16.5 Days STANDARD_DEVIATION 9.3 • n=5 Participants	17.8 Days STANDARD_DEVIATION 9.8 • n=7 Participants	17.3 Days STANDARD_DEVIATION 9.6 • n=5 Participants
Substance use days (past 30 days) Drug use days (excluding alcohol)	4.8 Days STANDARD_DEVIATION 9.2 • n=5 Participants	4.8 Days STANDARD_DEVIATION 9.0 • n=7 Participants	4.8 Days STANDARD_DEVIATION 9.0 • n=5 Participants
Substance use days (past 30 days) Primary substance use days	13.4 Days STANDARD_DEVIATION 9.9 • n=5 Participants	15.7 Days STANDARD_DEVIATION 10.4 • n=7 Participants	14.9 Days STANDARD_DEVIATION 10.3 • n=5 Participants
Substance use days (past 30 days) Heavy drinking days	9.8 Days STANDARD_DEVIATION 9.7 • n=5 Participants	13.5 Days STANDARD_DEVIATION 10.6 • n=7 Participants	12.3 Days STANDARD_DEVIATION 10.6 • n=5 Participants
Substance use days (past 30 days) Drinks per drinking day	7.0 Days STANDARD_DEVIATION 5.0 • n=5 Participants	11.3 Days STANDARD_DEVIATION 7.1 • n=7 Participants	10.0 Days STANDARD_DEVIATION 6.8 • n=5 Participants
Substance use days (past 30 days) Controlled environment days	0.38 Days STANDARD_DEVIATION 1.6 • n=5 Participants	0.26 Days STANDARD_DEVIATION 1.3 • n=7 Participants	.30 Days STANDARD_DEVIATION 1.4 • n=5 Participants
Addiction Severity Index (ASI) composite scores Alcohol	0.47 units on a scale from 0-1 STANDARD_DEVIATION 0.33 • n=5 Participants	0.55 units on a scale from 0-1 STANDARD_DEVIATION 0.29 • n=7 Participants	0.52 units on a scale from 0-1 STANDARD_DEVIATION 0.30 • n=5 Participants
Addiction Severity Index (ASI) composite scores Drug	0.07 units on a scale from 0-1 STANDARD_DEVIATION 0.11 • n=5 Participants	0.08 units on a scale from 0-1 STANDARD_DEVIATION 0.15 • n=7 Participants	0.08 units on a scale from 0-1 STANDARD_DEVIATION 0.13 • n=5 Participants
Addiction Severity Index (ASI) composite scores Medical	0.18 units on a scale from 0-1 STANDARD_DEVIATION 0.24 • n=5 Participants	0.18 units on a scale from 0-1 STANDARD_DEVIATION 0.27 • n=7 Participants	0.18 units on a scale from 0-1 STANDARD_DEVIATION 0.26 • n=5 Participants
Addiction Severity Index (ASI) composite scores Psychiatric	0.25 units on a scale from 0-1 STANDARD_DEVIATION 0.20 • n=5 Participants	0.19 units on a scale from 0-1 STANDARD_DEVIATION 0.19 • n=7 Participants	0.21 units on a scale from 0-1 STANDARD_DEVIATION 0.19 • n=5 Participants
Addiction Severity Index (ASI) composite scores Legal	0.04 units on a scale from 0-1 STANDARD_DEVIATION 0.11 • n=5 Participants	0.09 units on a scale from 0-1 STANDARD_DEVIATION 0.68 • n=7 Participants	0.07 units on a scale from 0-1 STANDARD_DEVIATION 0.56 • n=5 Participants
Addiction Severity Index (ASI) composite scores Family	0.29 units on a scale from 0-1 STANDARD_DEVIATION 0.55 • n=5 Participants	0.24 units on a scale from 0-1 STANDARD_DEVIATION 0.28 • n=7 Participants	0.26 units on a scale from 0-1 STANDARD_DEVIATION 0.39 • n=5 Participants
Addiction Severity Index (ASI) composite scores Employment	0.42 units on a scale from 0-1 STANDARD_DEVIATION 0.24 • n=5 Participants	0.43 units on a scale from 0-1 STANDARD_DEVIATION 0.29 • n=7 Participants	0.43 units on a scale from 0-1 STANDARD_DEVIATION 0.27 • n=5 Participants

PRIMARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Only women were included in this analysis.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Percent Change in Mean Days of Any Substance Use for Women In-treatment Phase (months 1-3)	-76.5 % change in mean substance use days Interval -83.9 to -65.7	-76.5 % change in mean substance use days Interval -85.0 to -63.0
Percent Change in Mean Days of Any Substance Use for Women 3 Month Post-treatment Phase (months 4-6)	-68.4 % change in mean substance use days Interval -76.9 to -56.8	-73.3 % change in mean substance use days Interval -83.0 to -58.1
Percent Change in Mean Days of Any Substance Use for Women 6 Month Post-Treatment Phase (months 7-9)	-62.2 % change in mean substance use days Interval -74.9 to -41.3	-70.8 % change in mean substance use days Interval -80.5 to -56.1

PRIMARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Only women were included in this analysis.

This represents the change from baseline in mean ASI Alcohol composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Change in Mean ASI Alcohol Composite Score for Women In-treatment Phase (months 1-3)	-0.27 change in ASI Alcohol composite score Interval -0.33 to -0.22	-0.33 change in ASI Alcohol composite score Interval -0.39 to -0.28
Change in Mean ASI Alcohol Composite Score for Women 3 Month Post-treatment Phase (months 4-6)	-0.28 change in ASI Alcohol composite score Interval -0.34 to -0.22	-0.36 change in ASI Alcohol composite score Interval -0.43 to -0.3
Change in Mean ASI Alcohol Composite Score for Women 6 Month Post-Treatment Phase (months 7-9)	-0.30 change in ASI Alcohol composite score Interval -0.39 to -0.21	-0.35 change in ASI Alcohol composite score Interval -0.44 to -0.26

PRIMARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Only women were included in this analysis.

This represents the change from baseline in mean ASI Drug composite scores. The ASI was administered at baseline, at months 1-6, and then at month 9. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline ASI data. Outcomes were analyzed using linear mixed effect models. These models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The ASI is a multidimensional assessment of substance-related problems which yields composite scores for alcohol use, drug use, psychiatric status, medical status, legal status, family/social relationships, and employment status. Composite scores range from 0 to 1, with higher scores indicating more significant problems.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Change in Mean ASI Drug Composite Score for Women In-treatment Phase (months 1-3)	-0.03 change in ASI Drug composite score Interval -0.05 to -0.02	-0.03 change in ASI Drug composite score Interval -0.05 to -0.01
Change in Mean ASI Drug Composite Score for Women 3 Month Post-treatment Phase (months 4-6)	-0.03 change in ASI Drug composite score Interval -0.05 to -0.01	-0.03 change in ASI Drug composite score Interval -0.05 to -0.01
Change in Mean ASI Drug Composite Score for Women 6 Month Post-Treatment Phase (months 7-9)	-0.02 change in ASI Drug composite score Interval -0.05 to 0.02	-0.04 change in ASI Drug composite score Interval -0.07 to 0.0

SECONDARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Some participants did not complete this measure at the specified time points. Only women were included in this analysis.

This represents the percent change from baseline in the mean number of alcohol use days. Days of alcohol use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline alcohol use data. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Percent Change in Mean Alcohol Use Days for Women In-treatment Phase (months 1-3)	-80.6 percent change in Alcohol Use Days Interval -87.5 to -69.9	-82.6 percent change in Alcohol Use Days Interval -89.7 to -67.2
Percent Change in Mean Alcohol Use Days for Women 3 Month Post-treatment Phase (months 4-6)	-70.3 percent change in Alcohol Use Days Interval -79.1 to -57.6	-80.5 percent change in Alcohol Use Days Interval -88.6 to -66.6
Percent Change in Mean Alcohol Use Days for Women 6 Month Post-Treatment Phase (months 7-9)	-67.8 percent change in Alcohol Use Days Interval -80.5 to -46.8	-80.4 percent change in Alcohol Use Days Interval -87.7 to -68.5

SECONDARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Only women were included in this analysis.

This represents the percent change from baseline in the mean number of drug use days (excluding alcohol) for women. Days of drug use was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drug use days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Percent Change in Mean Drug Use Days for Women In-treatment Phase (months 1-3)	-66.3 % change in mean drug use days Interval -85.5 to -21.8	-40.8 % change in mean drug use days Interval -62.4 to -6.8
Percent Change in Mean Drug Use Days for Women 3 Month Post-treatment Phase (months 4-6)	-76.7 % change in mean drug use days Interval -89.6 to -47.5	-51.1 % change in mean drug use days Interval -71.9 to 16.3
Percent Change in Mean Drug Use Days for Women 6 Month Post-Treatment Phase (months 7-9)	-62.2 % change in mean drug use days Interval -83.0 to -15.9	-41.9 % change in mean drug use days Interval -71.7 to 19.2

SECONDARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Only women were included in this analysis.

This represents the percent change from baseline in the mean number of heavy drinking days for women. Number of heavy drinking days was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean heavy drinking days. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Percent Change in Mean Heavy Drinking Days for Women In-treatment Phase (months 1-3)	-89.6 % change in mean heavy drinking days Interval -91.4 to -81.8	-85.7 % change in mean heavy drinking days Interval -92.7 to -72.0
Percent Change in Mean Heavy Drinking Days for Women 3 Month Post-treatment Phase (months 4-6)	-82.4 % change in mean heavy drinking days Interval -89.5 to -70.4	-82.0 % change in mean heavy drinking days Interval -90.0 to -67.5
Percent Change in Mean Heavy Drinking Days for Women 6 Month Post-Treatment Phase (months 7-9)	-83.8 % change in mean heavy drinking days Interval -91.2 to -70.3	-83.2 % change in mean heavy drinking days Interval -90.2 to -71.2

SECONDARY outcome

Timeframe: In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9)

Population: Only women were included in this analysis.

This represents the change from baseline in the mean number of drinks per drinking day. Drinks per drinking day was assessed using the Timeline Follow-Back at baseline and then monthly for 9 months. The In-Treatment phase includes months 1-3, the 3 Month Post-Treatment phase includes months 4-6, and the 6 Month Post-Treatment phase includes months 7-9. The in-treatment and 2 post-treatment phases were compared to baseline data of mean drinks per drinking day. Outcomes were analyzed using loglinear (negative binomial) regression models with estimation via generalized estimating equations (GEE). The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Change in Mean Drinks Per Drinking Day for Women In-treatment Phase (months 1-3)	-1.96 change in mean drinks per drinking day Interval -3.77 to -0.16	-2.87 change in mean drinks per drinking day Interval -4.74 to -1.01
Change in Mean Drinks Per Drinking Day for Women 3 Month Post-treatment Phase (months 4-6)	-1.47 change in mean drinks per drinking day Interval -3.91 to 0.98	-1.41 change in mean drinks per drinking day Interval -3.99 to 1.18
Change in Mean Drinks Per Drinking Day for Women 6 Month Post-treatment Phase (months 7-9)	-1.22 change in mean drinks per drinking day Interval -4.57 to 2.13	-0.76 change in mean drinks per drinking day Interval -4.28 to 2.76

OTHER_PRE_SPECIFIED outcome

Timeframe: In treatment (weeks 1-12)

All therapists were female to eliminate any therapist-patient gender matching effects. There were eight therapists in total: 4 who led WRG groups and 4 who led GDC groups. All group sessions were videotaped each week so that we could measure therapist adherence to the treatment they were assigned to. Two independent raters completed adherence scales for a random selection of 20% of WRG and 10%of GDC sessions. For both groups, the extensiveness to which the therapist engaged in a behavior during the session was rated with a 5-point Likert scale (0 = not at all; 4 = extensively). Adherence scores were calculated by averaging all scores for each question (25 questions for WRG; 18 for GDC) on the measure. The scores reported here represent the average of all WRG therapists scores from all session, and all GDC therapist scores from all sessions. Scores range from 0 to 4.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=28 Sessions The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=27 Sessions Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Therapist Adherence	3.8 units on a 0-4 adherence scale Standard Deviation 0.13	3.6 units on a 0-4 adherence scale Standard Deviation 0.28

OTHER_PRE_SPECIFIED outcome

Timeframe: In treatment (weeks 1-12)

Population: Only women were included in this analysis.

Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Group Attendance	7.64 sessions attended Standard Deviation 1.36	7.69 sessions attended Standard Deviation 1.36

OTHER_PRE_SPECIFIED outcome

Timeframe: In treatment (weeks 1-12)

Population: Only women were included in this analysis.

Treatment group stability was calculated using the Percentage of Group Change Index which captures change in group membership composition from session to session separately for each individual within each group (specific to the calendar period that each person was in the group). The value can range from 0 (i.e., the exact same membership from one session to the next) to 1 (i.e., complete turnover in membership). The average values across all sessions were taken to get an overall sense of the amount of turnover each person experienced in the group during the period in calendar time they were in treatment.

Outcome measures

Outcome measures
Measure	Women's Recovery Group n=52 Participants The Women's Recovery Group (WRG) is a manual-based group therapy for women heterogeneous with respect to their substance use disorder, co-occurring psychiatric disorders, trauma history, age, and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (2) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (3) help participants with skills and strategies useful in preventing relapse and promoting recovery.	Mixed-gender Group Drug Counseling n=48 Participants Group Drug Counseling (GDC) is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance use disorders; 3) increase patients' self-awareness of the problems that their substance use disorder has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community.
Group Stability	0.39 units on a scale Standard Deviation 0.07	0.36 units on a scale Standard Deviation 0.07

Adverse Events

Women's Recovery Group

Serious events: 4 serious events

Other events: 13 other events

Deaths: 0 deaths

Mixed-gender Group Drug Counseling

Serious events: 13 serious events

Other events: 8 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Women's Recovery Group n=52 participants at risk The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.	Mixed-gender Group Drug Counseling n=106 participants at risk The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance dependence; 3) increase patients' self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
General disorders Dehydration	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Nervous system disorders Seizure	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Overdose	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	1.9% 2/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Surgical and medical procedures Colon Surgery	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Gastrointestinal disorders Hospitalization	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Chest Pain	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Skin and subcutaneous tissue disorders Abscess	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Infections and infestations Post-Surgery Infection	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Nervous system disorders Stroke	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Number of events 2 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Cardiac disorders Heart Attack	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Cardiac disorders Death - Heart Attack	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	1.9% 2/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Nervous system disorders Death - Stroke	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Hospitalization	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Nervous system disorders Back Pain	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.

Other adverse events

Additional Information

Shelly F. Greenfield, MD, MPH

McLean Hospital

Phone: 617-855-2241

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Women's Recovery Group n=52 participants at risk The WRG is a manual-based group therapy for women heterogeneous with respect to their substance dependence, co-occurring psychiatric disorders, trauma history, and age and stage of life. The WRG is a 12-session, structured relapse-prevention group therapy that utilizes a cognitive behavioral approach and includes gender-specific content and single-gender group composition. Individual session content was derived from research on gender-specific substance use disorder antecedents, consequences, and treatment outcomes. The overall goals of the treatment are to (1) promote abstinence from all substances including alcohol; (b) improve understanding of specific aspects of SUDs, recovery, and relapse that are relevant to women, and (c) help participants with skills and strategies useful in preventing relapse and promote recovery.	Mixed-gender Group Drug Counseling n=106 participants at risk The GDC is a standard 12-week, 90-minute mixed-gender group therapy. The overall goals of GDC are to 1) help patients to achieve abstinence from all substances including alcohol; 2) educate patients regarding recovery from substance dependence; 3) increase patients' self-awareness of the problems that substance dependence has caused; 4) encourage patients to give mutual support; and 5) help patients learn new ways to cope with problems in order to prevent relapse.
Respiratory, thoracic and mediastinal disorders Acute Asthma Episode	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Alcohol Intoxication	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Gastrointestinal disorders Gastrointestinal Virus Hospitalization	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	1.9% 2/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Fainting Episode	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Respiratory, thoracic and mediastinal disorders Bronchitis	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Surgical and medical procedures Surgical Procedure - Removal of Lymph Nodes	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Ovarian Cyst	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Social circumstances Motor Vehicle Accident	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Hospitalization	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Gastrointestinal disorders Gastrointestinal Discomfort	3.8% 2/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Musculoskeletal and connective tissue disorders Broken Arm	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Musculoskeletal and connective tissue disorders Back Pain	3.8% 2/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Infections and infestations Animal Bite	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
Psychiatric disorders Involuntary Psychiatric Hospitalization	1.9% 1/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.00% 0/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.
General disorders Dehydration	0.00% 0/52 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.	0.94% 1/106 • Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011). Adverse events were collected between November of 2009 and August 2011, during which participants were either in treatment or completing 3-month and 6-month post-treatment assessments.