Alcohol-Related Disorders, Substance-Related Disorders
Conditions
Keywords
Substance use disorders, Gender differences, women, treatment outcomes, group therapy
Brief summary
The purpose of this Stage II randomized controlled behavioral treatment development trial was to test the effectiveness of the Women's Recovery Group (WRG) relative to mixed-gender Group Drug Counseling (GDC) and demonstrate the feasibility of implementing the WRG in an open-enrollment (i.e., rolling admission) group format at two clinical sites. The Stage II trial aims were to (1) investigate effectiveness of the WRG relative to GDC in a sample of women heterogeneous with respect to substance use and co-occurring psychiatric disorders, and (2) demonstrate the feasibility of implementing WRG in an open enrollment group format characteristic of community treatment programs at two sites.
Detailed description
This Stage II trial builds on the Stage I trial that compared the single-gender WRG to mixed-gender GDC and demonstrated preliminary support for the WRG in treating women with substance use disorders (SUDs). It was hypothesized that women in the WRG would decrease their substance use more so than women in the GDC. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. 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. There are 14 specific session topics that can be flexibly implemented in any order for a 12-week sequence of groups. In the Stage I trial, women were randomized to WRG (n=16) or mixed-gender GDC (n =7). No significant differences in outcomes emerged between WRG and GDC during the 12 week group sequence. However, in the 6 months post-treatment, WRG participants showed a pattern of continued reductions in substance use while GDC participants did not. While the design of the Stage I trial was essential for treatment development and testing, the Stage I trial had a small sample size and used a semi-closed enrollment format. However, most treatment is delivered in an open enrollment format (i.e., rolling admission) in which patients enter at any time in the group sequence and exit the group after 12 weeks are completed. Because WRG is intended to be a manual-based treatment ready for dissemination into clinical practice if demonstrated to be effective, the Stage II trial was designed to be implemented in an open group format and to enroll a larger, more diverse sample at two clinical sites. The study was designed to investigate the effectiveness of the WRG relative to the GDC in (1) reducing days of use of any substance from baseline in a sample of women with heterogeneity with regard to their substance dependence, co-occurring psychiatric disorders, and other demographic characteristics, and (2) to demonstrate the feasibility of implementing the WRG in an open-enrollment group format.
Interventions
BEHAVIORALThe 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.
BEHAVIORALGroup 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.
Sponsors
National Institute on Drug Abuse (NIDA)
Mclean Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects were included in the study if they: * were 18 years or older * used substances within the past 60 days * met current Diagnostic and Statistical Manual (DSM)-IV criteria (American Psychiatric Association, 2000; World Health Organization, 1997) of substance dependence (in addition to any nicotine dependence) * planned to stay within the area during the study period * consented for study personnel to communicate with other mental health professionals from whom they are receiving care * furnished the names of two locators who can assist study personnel in locating them during the study period * were interested in group treatment * lived close enough either to McLean Hospital or SSTAR to come to group weekly * were able to sign informed consent.
Exclusion criteria
* Patients were excluded if they: * had a current medical condition that would prevent regular group attendance * had mental retardation or organic mental disorder * had certain other major Axis I psychiatric disorders according to the Composite International Diagnostic Interview (CIDI), such as psychotic disorders or bipolar I disorder * would be in a residential treatment setting throughout the treatment period in which substance use is monitored and restricted (e.g., a therapeutic community) * required medical detoxification (these patients could enter the study after being detoxified) * were current intravenous drug users * engaged in self-destructive behaviors (e.g., life-threatening bulimia or anorexia, suicide attempts and chronic suicidality) or other behaviors (e.g., violence toward others, assault behaviors)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean ASI Alcohol Composite Score for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
| Percent Change in Mean Days of Any Substance Use for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
| Change in Mean ASI Drug Composite Score for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Mean Drinks Per Drinking Day for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
| Percent Change in Mean Heavy Drinking Days for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
| Percent Change in Mean Alcohol Use Days for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
| Percent Change in Mean Drug Use Days for Women | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Therapist Adherence | 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. |
| Group Stability | In treatment (weeks 1-12) | 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. |
| Group Attendance | In treatment (weeks 1-12) | Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 52 |
| 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. 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). | 106 |
| Total | 158 |
Baseline characteristics
| Characteristic | Total | Mixed-gender Group Drug Counseling | Women's Recovery Group |
|---|---|---|---|
| Addiction Severity Index (ASI) composite scores Alcohol | 0.52 units on a scale from 0-1 STANDARD_DEVIATION 0.3 | 0.55 units on a scale from 0-1 STANDARD_DEVIATION 0.29 | 0.47 units on a scale from 0-1 STANDARD_DEVIATION 0.33 |
| Addiction Severity Index (ASI) composite scores Drug | 0.08 units on a scale from 0-1 STANDARD_DEVIATION 0.13 | 0.08 units on a scale from 0-1 STANDARD_DEVIATION 0.15 | 0.07 units on a scale from 0-1 STANDARD_DEVIATION 0.11 |
| Addiction Severity Index (ASI) composite scores Employment | 0.43 units on a scale from 0-1 STANDARD_DEVIATION 0.27 | 0.43 units on a scale from 0-1 STANDARD_DEVIATION 0.29 | 0.42 units on a scale from 0-1 STANDARD_DEVIATION 0.24 |
| Addiction Severity Index (ASI) composite scores Family | 0.26 units on a scale from 0-1 STANDARD_DEVIATION 0.39 | 0.24 units on a scale from 0-1 STANDARD_DEVIATION 0.28 | 0.29 units on a scale from 0-1 STANDARD_DEVIATION 0.55 |
| Addiction Severity Index (ASI) composite scores Legal | 0.07 units on a scale from 0-1 STANDARD_DEVIATION 0.56 | 0.09 units on a scale from 0-1 STANDARD_DEVIATION 0.68 | 0.04 units on a scale from 0-1 STANDARD_DEVIATION 0.11 |
| Addiction Severity Index (ASI) composite scores Medical | 0.18 units on a scale from 0-1 STANDARD_DEVIATION 0.26 | 0.18 units on a scale from 0-1 STANDARD_DEVIATION 0.27 | 0.18 units on a scale from 0-1 STANDARD_DEVIATION 0.24 |
| Addiction Severity Index (ASI) composite scores Psychiatric | 0.21 units on a scale from 0-1 STANDARD_DEVIATION 0.19 | 0.19 units on a scale from 0-1 STANDARD_DEVIATION 0.19 | 0.25 units on a scale from 0-1 STANDARD_DEVIATION 0.2 |
| Age, Continuous | 47 Years STANDARD_DEVIATION 12.2 | 47.6 Years STANDARD_DEVIATION 12 | 45.7 Years STANDARD_DEVIATION 12.6 |
| Current psychiatric diagnoses Any Axis I | 116 participants | 79 participants | 37 participants |
| Current psychiatric diagnoses Any Axis II | 24 participants | 15 participants | 9 participants |
| Current psychiatric diagnoses Generalized anxiety disorder | 31 participants | 20 participants | 11 participants |
| Current psychiatric diagnoses Major depressive disorder | 88 participants | 58 participants | 30 participants |
| Current psychiatric diagnoses Post-traumatic stress disorder | 29 participants | 20 participants | 9 participants |
| Education Did not graduate high school | 11 participants | 7 participants | 4 participants |
| Education Graduated from college | 52 participants | 34 participants | 18 participants |
| Education Graduated high school | 29 participants | 22 participants | 7 participants |
| Education Postgraduate | 33 participants | 21 participants | 12 participants |
| Education Some college | 33 participants | 22 participants | 11 participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 1 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 157 Participants | 105 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Household Income $0-$20,000 | 43 participants | 26 participants | 17 participants |
| Household Income $20,001-$50,000 | 40 participants | 31 participants | 9 participants |
| Household Income $50,001-$100,000 | 39 participants | 28 participants | 11 participants |
| Household Income More than $100,000 | 36 participants | 21 participants | 15 participants |
| Marital Status Divorced/Separated | 44 participants | 27 participants | 17 participants |
| Marital Status Married | 60 participants | 41 participants | 19 participants |
| Marital Status Never married | 42 participants | 30 participants | 12 participants |
| Marital Status Unmarried and living with partner | 9 participants | 5 participants | 4 participants |
| Marital Status Widowed | 3 participants | 3 participants | 0 participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 5 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 149 Participants | 101 Participants | 48 Participants |
| Sex: Female, Male Female | 100 Participants | 48 Participants | 52 Participants |
| Sex: Female, Male Male | 58 Participants | 58 Participants | 0 Participants |
| Substance use days (past 30 days) Alcohol use days | 14.6 Days STANDARD_DEVIATION 10.3 | 15.4 Days STANDARD_DEVIATION 10.5 | 12.7 Days STANDARD_DEVIATION 9.9 |
| Substance use days (past 30 days) Controlled environment days | .30 Days STANDARD_DEVIATION 1.4 | 0.26 Days STANDARD_DEVIATION 1.3 | 0.38 Days STANDARD_DEVIATION 1.6 |
| Substance use days (past 30 days) Days of any substance use (including alcohol) | 17.3 Days STANDARD_DEVIATION 9.6 | 17.8 Days STANDARD_DEVIATION 9.8 | 16.5 Days STANDARD_DEVIATION 9.3 |
| Substance use days (past 30 days) Drinks per drinking day | 10.0 Days STANDARD_DEVIATION 6.8 | 11.3 Days STANDARD_DEVIATION 7.1 | 7.0 Days STANDARD_DEVIATION 5 |
| Substance use days (past 30 days) Drug use days (excluding alcohol) | 4.8 Days STANDARD_DEVIATION 9 | 4.8 Days STANDARD_DEVIATION 9 | 4.8 Days STANDARD_DEVIATION 9.2 |
| Substance use days (past 30 days) Heavy drinking days | 12.3 Days STANDARD_DEVIATION 10.6 | 13.5 Days STANDARD_DEVIATION 10.6 | 9.8 Days STANDARD_DEVIATION 9.7 |
| Substance use days (past 30 days) Primary substance use days | 14.9 Days STANDARD_DEVIATION 10.3 | 15.7 Days STANDARD_DEVIATION 10.4 | 13.4 Days STANDARD_DEVIATION 9.9 |
| Substance use diagnoses Alcohol current | 140 participants | 97 participants | 43 participants |
| Substance use diagnoses Alcohol lifetime | 146 participants | 101 participants | 45 participants |
| Substance use diagnoses Cannabis current | 19 participants | 16 participants | 3 participants |
| Substance use diagnoses Cannabis lifetime | 34 participants | 27 participants | 7 participants |
| Substance use diagnoses Cocaine current | 28 participants | 20 participants | 8 participants |
| Substance use diagnoses Cocaine lifetime | 57 participants | 40 participants | 17 participants |
| Substance use diagnoses Opioids current | 26 participants | 19 participants | 7 participants |
| Substance use diagnoses Opioids lifetime | 40 participants | 27 participants | 13 participants |
| Substance use diagnoses Sedatives current | 16 participants | 11 participants | 5 participants |
| Substance use diagnoses Sedatives lifetime | 22 participants | 17 participants | 5 participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 13 / 52 | 8 / 106 |
| serious Total, serious adverse events | 4 / 52 | 13 / 106 |
Outcome results
Primary
Change in Mean ASI Alcohol Composite Score for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | Change in Mean ASI Alcohol Composite Score for Women | In-treatment Phase (months 1-3) | -0.27 change in ASI Alcohol composite score |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | Change in Mean ASI Alcohol Composite Score for Women | In-treatment Phase (months 1-3) | -0.33 change in ASI Alcohol composite score |
| Mixed-gender Group Drug Counseling | Change in Mean ASI Alcohol Composite Score for Women | 3 Month Post-treatment Phase (months 4-6) | -0.36 change in ASI Alcohol composite score |
| Mixed-gender Group Drug Counseling | Change in Mean ASI Alcohol Composite Score for Women | 6 Month Post-Treatment Phase (months 7-9) | -0.35 change in ASI Alcohol composite score |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).p-value: 0.253Linear mixed effect models
Primary
Change in Mean ASI Drug Composite Score for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | Change in Mean ASI Drug Composite Score for Women | In-treatment Phase (months 1-3) | -0.03 change in ASI Drug composite score |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | Change in Mean ASI Drug Composite Score for Women | In-treatment Phase (months 1-3) | -0.03 change in ASI Drug composite score |
| Mixed-gender Group Drug Counseling | 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 |
| Mixed-gender Group Drug Counseling | Change in Mean ASI Drug Composite Score for Women | 6 Month Post-Treatment Phase (months 7-9) | -0.04 change in ASI Drug composite score |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores.With 100 women (50 in each treatment group), the study was adequately powered to detect a 0.2 benefit in the ASI drug and alcohol composite scores (power = 94%).p-value: 0.667Linear mixed effect models
Primary
Percent Change in Mean Days of Any Substance Use for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | 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 |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Days of Any Substance Use for Women | 3 Month Post-treatment Phase (months 4-6) | -73.3 % change in mean substance use days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Days of Any Substance Use for Women | 6 Month Post-Treatment Phase (months 7-9) | -70.8 % change in mean substance use days |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction.The study was powered for the primary analysis concerning treatment group differences in the degree of improvement in the number of days of any substance use and in the Addiction Severity Index (ASI) composite scores. With a total of 100 women, the study was adequately powered to detect a minimum 5 day benefit in the # of days of any substance use (power = 83%).p-value: 0.821loglinear (negative binomial) regression
Secondary
Change in Mean Drinks Per Drinking Day for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | Change in Mean Drinks Per Drinking Day for Women | In-treatment Phase (months 1-3) | -1.96 change in mean drinks per drinking day |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | Change in Mean Drinks Per Drinking Day for Women | In-treatment Phase (months 1-3) | -2.87 change in mean drinks per drinking day |
| Mixed-gender Group Drug Counseling | Change in Mean Drinks Per Drinking Day for Women | 3 Month Post-treatment Phase (months 4-6) | -1.41 change in mean drinks per drinking day |
| Mixed-gender Group Drug Counseling | Change in Mean Drinks Per Drinking Day for Women | 6 Month Post-treatment Phase (months 7-9) | -0.76 change in mean drinks per drinking day |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment by phase interaction. Note: Women in both the WRG and GDC groups had significant (p\<0.05) reductions in mean number of drinks per drinking day only during the in treatment phase (2.0 and 2.9 reductions for WRG and GDC, respectively).p-value: 0.799linear mixed effect model
Secondary
Percent Change in Mean Alcohol Use Days for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | Percent Change in Mean Alcohol Use Days for Women | In-treatment Phase (months 1-3) | -80.6 percent change in Alcohol Use Days |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Alcohol Use Days for Women | In-treatment Phase (months 1-3) | -82.6 percent change in Alcohol Use Days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Alcohol Use Days for Women | 3 Month Post-treatment Phase (months 4-6) | -80.5 percent change in Alcohol Use Days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Alcohol Use Days for Women | 6 Month Post-Treatment Phase (months 7-9) | -80.4 percent change in Alcohol Use Days |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001 reductions in mean # of alcohol use days during treatment (9.9 and 12.4 day reductions for WRG and GDC respectively) and at 6 months post-treatment (8.3 and 12.2 day reductions).p-value: 0.519loglinear (negative binomial) regression
Secondary
Percent Change in Mean Drug Use Days for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | Percent Change in Mean Drug Use Days for Women | In-treatment Phase (months 1-3) | -66.3 % change in mean drug use days |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Drug Use Days for Women | In-treatment Phase (months 1-3) | -40.8 % change in mean drug use days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Drug Use Days for Women | 3 Month Post-treatment Phase (months 4-6) | -51.1 % change in mean drug use days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Drug Use Days for Women | 6 Month Post-Treatment Phase (months 7-9) | -41.9 % change in mean drug use days |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.05) reductions in mean number of drug use days during treatment (3.0 and 1.5 day reductions for WRG and GDC respectively); however at 6 months post-treatment, the reductions were significant for WRG (2.8 day reduction; p\<0.05) but not for GDC (1.5 day reduction; p\>0.01).p-value: 0.464loglinear (negative binomial) regression
Secondary
Percent Change in Mean Heavy Drinking Days for Women
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.
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Women's Recovery Group | Percent Change in Mean Heavy Drinking Days for Women | In-treatment Phase (months 1-3) | -89.6 % change in mean heavy drinking days |
| Women's Recovery Group | 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 |
| Women's Recovery Group | 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 |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Heavy Drinking Days for Women | In-treatment Phase (months 1-3) | -85.7 % change in mean heavy drinking days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Heavy Drinking Days for Women | 3 Month Post-treatment Phase (months 4-6) | -82.0 % change in mean heavy drinking days |
| Mixed-gender Group Drug Counseling | Percent Change in Mean Heavy Drinking Days for Women | 6 Month Post-Treatment Phase (months 7-9) | -83.2 % change in mean heavy drinking days |
Comparison: The models included the effects of treatment group, phase (3 levels), and the treatment group by phase interaction. Note: Women in both WRG and GDC groups had significant (p\<0.0001) reductions in mean number of heavy drinking days during treatment (8.6 and 12.1 days reduction for WRG and GDC, respectively) and at 6 months post-treatment (8.0 and 11.8 day reductions).p-value: 0.904loglinear (negative binomial) regression
Other Pre-specified
Group Attendance
Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12.
Time frame: In treatment (weeks 1-12)
Population: Only women were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women's Recovery Group | Group Attendance | 7.64 sessions attended | Standard Deviation 1.36 |
| Mixed-gender Group Drug Counseling | Group Attendance | 7.69 sessions attended | Standard Deviation 1.36 |
p-value: >0.05t-test, 2 sided
Other Pre-specified
Group Stability
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.
Time frame: In treatment (weeks 1-12)
Population: Only women were included in this analysis.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women's Recovery Group | Group Stability | 0.39 units on a scale | Standard Deviation 0.07 |
| Mixed-gender Group Drug Counseling | Group Stability | 0.36 units on a scale | Standard Deviation 0.07 |
p-value: >0.05t-test, 2 sided
Other Pre-specified
Therapist Adherence
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.
Time frame: In treatment (weeks 1-12)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Women's Recovery Group | Therapist Adherence | 3.8 units on a 0-4 adherence scale | Standard Deviation 0.13 |
| Mixed-gender Group Drug Counseling | Therapist Adherence | 3.6 units on a 0-4 adherence scale | Standard Deviation 0.28 |