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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Women's Recovery Group | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| The Women's Recovery Group | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Subjects were included in the study if they:
Exclusion Criteria:
Patients were excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Shelly F Greenfield, MD, MPH | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 | United States | ||
| Stanley Street Treatment and Resources (SSTAR) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24724875 | Background | Greenfield SF, Crisafulli MA, Kaufman JS, Freid CM, Bailey GL, Connery HS, Rapoza M, Rodolico J. Implementing substance abuse group therapy clinical trials in real-world settings: challenges and strategies for participant recruitment and therapist training in the Women's Recovery Group Study. Am J Addict. 2014 May-Jun;23(3):197-204. doi: 10.1111/j.1521-0391.2014.12099.x. | |
| Background | Greenfield SF. Treating Women with Substance Use Disorders: The Women's Recovery Group Manual. New York: Guilford Press; 2016. | ||
| 25042759 |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| FG002 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | % change in mean substance use days | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Women's Recovery Group | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dehydration | General disorders | Non-systematic Assessment | Participant hospitalized for dehydration; unrelated to study |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute Asthma Episode | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | One participant required a hospital visit; the other required an overnight hospitalization |
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelly F. Greenfield, MD, MPH | McLean Hospital | 617-855-2241 | sgreenfield@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
|
| Group Drug Counseling | Behavioral | 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. |
|
|
| In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
| 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. | 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. | 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. | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
| 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. | 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. | In treatment (weeks 1-12) |
| Fall River |
| Massachusetts |
| 02720 |
| United States |
| Result |
| Greenfield SF, Sugarman DE, Freid CM, Bailey GL, Crisafulli MA, Kaufman JS, Wigderson S, Connery HS, Rodolico J, Morgan-Lopez AA, Fitzmaurice GM. Group therapy for women with substance use disorders: results from the Women's Recovery Group Study. Drug Alcohol Depend. 2014 Sep 1;142:245-53. doi: 10.1016/j.drugalcdep.2014.06.035. Epub 2014 Jul 4. |
| 27647710 | Result | Sugarman DE, Wigderson SB, Iles BR, Kaufman JS, Fitzmaurice GM, Hilario EY, Robbins MS, Greenfield SF. Measuring affiliation in group therapy for substance use disorders in the Women's Recovery Group study: Does it matter whether the group is all-women or mixed-gender? Am J Addict. 2016 Oct;25(7):573-80. doi: 10.1111/ajad.12443. Epub 2016 Sep 20. |
| BG001 | 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). |
| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Marital Status | Number | participants |
|
| Education | Number | participants |
|
| Household Income | Number | participants |
|
| Current psychiatric diagnoses | Number | participants |
|
| Substance use diagnoses | Number | participants |
|
| Substance use days (past 30 days) | Mean | Standard Deviation | Days |
|
| Addiction Severity Index (ASI) composite scores | The Addiction Severity Index (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. | Mean | Standard Deviation | units on a scale from 0-1 |
|
| OG000 |
| 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. |
| OG001 | 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. |
|
|
|
| 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. | Some participants did not complete this measure at the specified time points. Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | percent change in Alcohol Use Days | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
|
|
|
|
| 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. | Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | change in ASI Alcohol composite score | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
|
|
|
|
| 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. | Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | change in ASI Drug composite score | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a 0-4 adherence scale | In treatment (weeks 1-12) | Sessions | Sessions |
|
|
|
| Other Pre-specified | Group Attendance | Treatment attendance was calculated by summing the number of treatment sessions attended. Therefore, numbers range from 0-12. | Only women were included in this analysis. | Posted | Mean | Standard Deviation | sessions attended | In treatment (weeks 1-12) |
|
|
|
|
| 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. | Only women were included in this analysis. | Posted | Mean | Standard Deviation | units on a scale | In treatment (weeks 1-12) |
|
|
|
|
| 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. | Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | % change in mean drug use days | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
|
|
|
|
| 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. | Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | % change in mean heavy drinking days | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
|
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| 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. | Only women were included in this analysis. | Posted | Mean | 95% Confidence Interval | change in mean drinks per drinking day | In-treatment (months 1-3), 3 Month Post-treatment (months 4-6), 6 Month Post-Treatment (months 7-9) |
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| 4 |
| 52 |
| 13 |
| 52 |
| EG001 | Mixed-gender Group Drug Counseling | 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. | 13 | 106 | 8 | 106 |
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| Seizure | Nervous system disorders | Non-systematic Assessment | Participant had a seizure and went to the emergency department; unrelated to study |
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| Overdose | General disorders | Non-systematic Assessment | One participant overdosed on Lyrica and required a visit to the emergency department; another participant overdosed on heroin and was admitted to the hospital for one night. Both were unrelated to the study |
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| Colon Surgery | Surgical and medical procedures | Non-systematic Assessment | Participant was hospitalized for colon surgery; unrelated to study |
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| Hospitalization | Gastrointestinal disorders | Non-systematic Assessment | One participant was hospitalized for an intestinal obstruction; another participant was hospitalized for bleeding ulcers. Both were unrelated to the study |
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| Chest Pain | General disorders | Non-systematic Assessment | Participant experienced chest pain and was admitted to the hospital for observation; unrelated to study |
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| Abscess | Skin and subcutaneous tissue disorders | Non-systematic Assessment | Participant had abscess on leg; unrelated to study |
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| Post-Surgery Infection | Infections and infestations | Non-systematic Assessment | Participant had surgery and was hospitalized overnight for a post-surgery infection; unrelated to study |
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| Stroke | Nervous system disorders | Non-systematic Assessment | Participant had a stroke twice; unrelated to study |
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| Heart Attack | Cardiac disorders | Non-systematic Assessment | Participant was hospitalized for a heart attack; unrelated to study |
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| Death - Heart Attack | Cardiac disorders | Non-systematic Assessment | Two participants passed away from a heart attack; both were unrelated to the study |
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| Death - Stroke | Nervous system disorders | Non-systematic Assessment | Participant passed away from a stroke; unrelated to study |
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| Hospitalization | General disorders | Non-systematic Assessment | Participant was hospitalized for anemia; unrelated to study |
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| Back Pain | Nervous system disorders | Non-systematic Assessment | Participant hurt his back, went to the emergency department, and was admitted to the hospital. He was later diagnosed with sciatica; unrelated to study |
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| Alcohol Intoxication | General disorders | Non-systematic Assessment | Required a visit to the emergency department |
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| Gastrointestinal Virus Hospitalization | Gastrointestinal disorders | Non-systematic Assessment |
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| Pneumonia | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Required a visit to the emergency department |
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| Fainting Episode | General disorders | Non-systematic Assessment | Required a hospitalization |
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| Bronchitis | Respiratory, thoracic and mediastinal disorders | Non-systematic Assessment | Required a visit to the emergency department |
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| Surgical Procedure - Removal of Lymph Nodes | Surgical and medical procedures | Non-systematic Assessment |
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| Ovarian Cyst | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | Required a hospitalization |
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| Motor Vehicle Accident | Social circumstances | Non-systematic Assessment | Required a hospitalization |
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| Hospitalization | General disorders | Non-systematic Assessment | Participant was hospitalized for risk of suicide |
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| Gastrointestinal Discomfort | Gastrointestinal disorders | Non-systematic Assessment | Required a visit to the emergency department |
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| Broken Arm | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Required a visit to the emergency department |
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| Back Pain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Required a visit to the emergency department |
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| Animal Bite | Infections and infestations | Non-systematic Assessment | Participant received IV antibiotics for cat bite in the emergency department |
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| Involuntary Psychiatric Hospitalization | Psychiatric disorders | Non-systematic Assessment |
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| Dehydration | General disorders | Non-systematic Assessment | Required a visit to the emergency department |
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Not provided
Not provided
| 6 Month Post-Treatment Phase (months 7-9) |
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| 6 Month Post-Treatment Phase (months 7-9) |
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| Superiority or Other |
| 6 Month Post-Treatment Phase (months 7-9) |
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| Superiority or Other |
| 6 Month Post-Treatment Phase (months 7-9) |
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| 6 Month Post-Treatment Phase (months 7-9) |
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| 6 Month Post-treatment Phase (months 7-9) |
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