An interventional study of The Women's Recovery Group and Group Drug Counseling in Substance-Related Disorders and Alcohol-Related Disorders, sponsored by Mclean Hospital. Completed at 2 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-05.
Sponsored by Mclean Hospital · Not applicable, Interventional, and Treatment
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.
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.
2,124 studies on the registry are indexed under Substance-Related Disorders; 393 are open to participants now.
This study's enrollment of 158 is above the median of 108 across 1,727 interventional studies indexed under Substance-Related Disorders.
Browse Substance-Related Disorders studies →Mclean Hospital is the lead sponsor of 181 studies on the registry; 32 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 10 (71%) have results posted.
Counted across the registry records on this site, refreshed daily.
Subjects were included in the study if they:
Exclusion Criteria:
Patients were excluded if they:
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.
Behavioral: The Women's Recovery Group
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.
Behavioral: Group Drug Counseling
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.
Also known as: WRG
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.
Also known as: GDC
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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.
| Milestone | Women's Recovery Group | Mixed-gender Group Drug Counseling | Group Therapist |
|---|---|---|---|
| Started | 52 | 106 | 8 |
| Completed | 52 | 106 | 8 |
| Not completed | 0 | 0 | 0 |
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 substance use days | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -76.5 (-83.9 to -65.7) | -76.5 (-85.0 to -63.0) |
| 3 Month Post-treatment Phase (months 4-6) | -68.4 (-76.9 to -56.8) | -73.3 (-83.0 to -58.1) |
| 6 Month Post-Treatment Phase (months 7-9) | -62.2 (-74.9 to -41.3) | -70.8 (-80.5 to -56.1) |
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 Alcohol Use Days | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -80.6 (-87.5 to -69.9) | -82.6 (-89.7 to -67.2) |
| 3 Month Post-treatment Phase (months 4-6) | -70.3 (-79.1 to -57.6) | -80.5 (-88.6 to -66.6) |
| 6 Month Post-Treatment Phase (months 7-9) | -67.8 (-80.5 to -46.8) | -80.4 (-87.7 to -68.5) |
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.
| change in ASI Alcohol composite score | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -0.27 (-0.33 to -0.22) | -0.33 (-0.39 to -0.28) |
| 3 Month Post-treatment Phase (months 4-6) | -0.28 (-0.34 to -0.22) | -0.36 (-0.43 to -0.30) |
| 6 Month Post-Treatment Phase (months 7-9) | -0.30 (-0.39 to -0.21) | -0.35 (-0.44 to -0.26) |
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.
| change in ASI Drug composite score | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -0.03 (-0.05 to -0.02) | -0.03 (-0.05 to -0.01) |
| 3 Month Post-treatment Phase (months 4-6) | -0.03 (-0.05 to -0.01) | -0.03 (-0.05 to -0.01) |
| 6 Month Post-Treatment Phase (months 7-9) | -0.02 (-0.05 to 0.02) | -0.04 (-0.07 to 0.00) |
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.
| units on a 0-4 adherence scale | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| Therapist Adherence | 3.8 ± 0.13 | 3.6 ± 0.28 |
Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12.
| sessions attended | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| Group Attendance | 7.64 ± 1.36 | 7.69 ± 1.36 |
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.
| units on a scale | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| Group Stability | 0.39 ± 0.07 | 0.36 ± 0.07 |
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.
| % change in mean drug use days | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -66.3 (-85.5 to -21.8) | -40.8 (-62.4 to -6.8) |
| 3 Month Post-treatment Phase (months 4-6) | -76.7 (-89.6 to -47.5) | -51.1 (-71.9 to 16.3) |
| 6 Month Post-Treatment Phase (months 7-9) | -62.2 (-83.0 to -15.9) | -41.9 (-71.7 to 19.2) |
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.
| % change in mean heavy drinking days | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -89.6 (-91.4 to -81.8) | -85.7 (-92.7 to -72.0) |
| 3 Month Post-treatment Phase (months 4-6) | -82.4 (-89.5 to -70.4) | -82.0 (-90.0 to -67.5) |
| 6 Month Post-Treatment Phase (months 7-9) | -83.8 (-91.2 to -70.3) | -83.2 (-90.2 to -71.2) |
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.
| change in mean drinks per drinking day | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| In-treatment Phase (months 1-3) | -1.96 (-3.77 to -0.16) | -2.87 (-4.74 to -1.01) |
| 3 Month Post-treatment Phase (months 4-6) | -1.47 (-3.91 to 0.98) | -1.41 (-3.99 to 1.18) |
| 6 Month Post-treatment Phase (months 7-9) | -1.22 (-4.57 to 2.13) | -0.76 (-4.28 to 2.76) |
Collected over Adverse events were recorded over a period of 1 year and 9 months (November 2009 to August 2011).. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Women's Recovery Group | — | 4/52 (7.7%) | 13/52 (25%) |
| Mixed-gender Group Drug Counseling | — | 13/106 (12.3%) | 8/106 (7.5%) |
| Event | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| Colon SurgerySurgical and medical procedures | 1/52 | 0/106 |
| HospitalizationGastrointestinal disorders | 1/52 | 1/106 |
| Chest PainGeneral disorders | 1/52 | 0/106 |
| AbscessSkin and subcutaneous tissue disorders | 1/52 | 0/106 |
| OverdoseGeneral disorders | 0/52 | 2/106 |
| Death - Heart AttackCardiac disorders | 0/52 | 2/106 |
| DehydrationGeneral disorders | 0/52 | 1/106 |
| SeizureNervous system disorders | 0/52 | 1/106 |
| Post-Surgery InfectionInfections and infestations | 0/52 | 1/106 |
| StrokeNervous system disorders | 0/52 | 1/106 |
| Event | Women's Recovery Group | Mixed-gender Group Drug Counseling |
|---|---|---|
| Gastrointestinal DiscomfortGastrointestinal disorders | 2/52 | 0/106 |
| Back PainMusculoskeletal and connective tissue disorders | 2/52 | 0/106 |
| Acute Asthma EpisodeRespiratory, thoracic and mediastinal disorders | 1/52 | 1/106 |
| BronchitisRespiratory, thoracic and mediastinal disorders | 1/52 | 0/106 |
| Surgical Procedure - Removal of Lymph NodesSurgical and medical procedures | 1/52 | 0/106 |
| Ovarian CystNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 1/52 | 0/106 |
| Motor Vehicle AccidentSocial circumstances | 1/52 | 0/106 |
| HospitalizationGeneral disorders | 1/52 | 0/106 |
| Broken ArmMusculoskeletal and connective tissue disorders | 1/52 | 1/106 |
| Animal BiteInfections and infestations | 1/52 | 0/106 |
| Age, Continuous(Years) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| Mean | 45.7 ± 12.6 | 47.6 ± 12.0 | 47 ± 12.2 |
| Sex: Female, Male(Participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| Female | 52 | 48 | 100 |
| Male | 0 | 58 | 58 |
| Ethnicity (NIH/OMB)(Participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 52 | 105 | 157 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 3 | 5 | 8 |
| White | 48 | 101 | 149 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Marital Status(participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| Married | 19 | 41 | 60 |
| Divorced/Separated | 17 | 27 | 44 |
| Never married | 12 | 30 | 42 |
| Unmarried and living with partner | 4 | 5 | 9 |
| Widowed | 0 | 3 | 3 |
| Education(participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| Did not graduate high school | 4 | 7 | 11 |
| Graduated high school | 7 | 22 | 29 |
| Some college | 11 | 22 | 33 |
| Graduated from college | 18 | 34 | 52 |
| Postgraduate | 12 | 21 | 33 |
| Household Income(participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| $0-$20,000 | 17 | 26 | 43 |
| $20,001-$50,000 | 9 | 31 | 40 |
| $50,001-$100,000 | 11 | 28 | 39 |
| More than $100,000 | 15 | 21 | 36 |
| Current psychiatric diagnoses(participants) | Women's Recovery Group | Mixed-gender Group Drug Counseling | Total |
|---|---|---|---|
| Major depressive disorder | 30 | 58 | 88 |
| Generalized anxiety disorder | 11 | 20 | 31 |
| Post-traumatic stress disorder | 9 | 20 | 29 |
| Any Axis I | 37 | 79 | 116 |
| Any Axis II | 9 | 15 | 24 |
3 further baseline measures are reported on the registry.
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