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| ID | Type | Description | Link |
|---|---|---|---|
| R01DA015434 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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The purpose of this study was to develop a gender-specific 12-session, manual-based relapse prevention group for women with substance use disorders (SUDs).
This Phase I trial compares single-gender Women's Recovery Group (WRG) and an effective control condition, mixed-gender Group Drug Counseling (GDC). WRG is a new 12-session women-focused, manual-based relapse-prevention group therapy that uses a cognitive-behavioral approach. It is a 90-minute structured relapse prevention weekly group therapy with both women-focused content as well as an all-women group composition. The control condition, Group Drug Counseling (GDC), consists of 12 weekly 90-minute structured sessions and is conducted in a mixed-gender group composition and has no women-focused content. The GDC was chosen as the comparison group to approximate group drug counseling that is consistent with treatment as usual within the community. Both groups stress abstinence. Women are randomly assigned to one of the two conditions and the groups are conducted in a rolling group, semi-open format.
The treatment manual for a Women's Recovery Group (WRG) focused on the themes that are relevant to women with SUDs. There was an emphasis on educating patients about treatment and relapse prevention in a context that is relevant to women. The manual combined therapist information and instructions with patient worksheets, handouts and skills practices. The treatment intervention was conducted twice in a pre-pilot study led by study investigators. The investigators then conducted a pilot study in which outcomes among subjects receiving the treatment intervention were compared with outcomes of subjects who received the standard mixed-gender Group Drug Counseling (GDC), chosen to approximate treatment in the community.
The study hypothesis was that the single-gender group composition and women-focused group content would result in better treatment outcomes, including decrease number of days of substance use compared with baseline during follow-up, reduced substance use, and lengthened time to relapse, compared with the mixed-gender control.
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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 abuse 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 of abuse; 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 abuse 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 |
|---|---|---|
| Change in Mean Days of Any Substance Use for Women | This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
| Change in Mean Number of Drinking Days for Women | This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Mean Number of Drinks Per Drinking Day for Women | This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. |
| Measure | Description | Time Frame |
|---|---|---|
| Baseline Substance Use Data for Women | The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back. | Baseline |
Inclusion criteria:
Participants were included in the study if they:
Patients were excluded if they:
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| Name | Affiliation | Role |
|---|---|---|
| Shelly F Greenfield, M.D., M.P.H. | Mclean Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| McLean Hospital | Belmont | Massachusetts | 02478 9106 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17446014 | Result | Greenfield SF, Trucco EM, McHugh RK, Lincoln M, Gallop RJ. The Women's Recovery Group Study: a Stage I trial of women-focused group therapy for substance use disorders versus mixed-gender group drug counseling. Drug Alcohol Depend. 2007 Sep 6;90(1):39-47. doi: 10.1016/j.drugalcdep.2007.02.009. Epub 2007 Apr 18. | |
| 18821452 | Result | Greenfield SF, Potter JS, Lincoln MF, Popuch RE, Kuper L, Gallop RJ. High psychiatric symptom severity is a moderator of substance abuse treatment outcomes among women in single vs. mixed gender group treatment. Am J Drug Alcohol Abuse. 2008;34(5):594-602. doi: 10.1080/00952990802304980. |
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Groups were conducted in an semi-open format where enrollment continued until a maximum of 6-8 subjects were entered per group and then enrollment was closed until the end of the sequence.
Patients with current substance dependence were recruited from McLean Hospital programs, advertisements, flyers, and clinician referrals. Advertisements were for investigational group therapy for substance abuse but did not specify the Women's Recovery Group in order to minimize selection bias for women only interested in women's treatment.
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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 abuse 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 of abuse; 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. |
| 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 abuse 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 | Change in Mean Days of Any Substance Use for Women | This represents the change from baseline in the mean number of days per month of any substance use (i.e. drug and/or alcohol). Days of substance use was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. | Only women were included in this analysis. | Posted | Mean | Standard Error | Days of any substance use per month | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
|
Weekly from weeks 1-12 (in treatment)
Both women and men are included.
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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 abuse 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shelly F. Greenfield, MD, MPH | McLean Hospital | 617-855-2241 | sgreenfield@mclean.harvard.edu |
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| ID | Term |
|---|---|
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D000437 | Alcoholism |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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|
|
| mixed-gender 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 of abuse; 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 phase (month 1-3), Post-treatment phase (month 4-6, 9) |
| Change in Mean Addiction Severity Index Alcohol Composite Score for Women | This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity. | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
| Baseline Drinks Per Drinking Day for Women |
The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back. |
| Baseline |
| Baseline Addiction Severity Index Alcohol Composite Score for Women | The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. 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. | Baseline |
| 20625473 | Result | McHugh RK, Greenfield SF. Psychiatric Symptom Improvement in Women Following Group Substance Abuse Treatment: Results from the Women's Recovery Group Study. J Cogn Psychother. 2010 Apr 1;24(1):26-36. doi: 10.1891/0889-8391.24.1.26. |
| 21753920 | Result | Cummings AM, Gallop RJ, Greenfield SF. Self-efficacy and substance use outcomes for women in single gender versus mixed-gender group treatment. J Groups Addict Recover. 2010;5(1):4-16. doi: 10.1080/15560350903543915. |
| 20958851 | Result | Kuper LE, Gallop R, Greenfield SF. Changes in coping moderate substance abuse outcomes differentially across behavioral treatment modality. Am J Addict. 2010 Nov-Dec;19(6):543-9. doi: 10.1111/j.1521-0391.2010.00074.x. Epub 2010 Sep 23. |
| 23607675 | Result | Greenfield SF, Cummings AM, Kuper LE, Wigderson SB, Koro-Ljungberg M. A qualitative analysis of women's experiences in single-gender versus mixed-gender substance abuse group therapy. Subst Use Misuse. 2013 Jun;48(9):750-60. doi: 10.3109/10826084.2013.787100. Epub 2013 Apr 22. |
| 24294145 | Result | Greenfield SF, Kuper LE, Cummings AM, Robbins MS, Gallop RJ. Group Process in the single-gender Women's Recovery Group compared with mixed-gender Group Drug Counseling. J Groups Addict Recover. 2013;8(4):10.1080/1556035X.2013.836867. doi: 10.1080/1556035X.2013.836867. |
| 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 of abuse; 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| 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 abuse 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 of abuse; 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. |
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| Primary | Change in Mean Number of Drinking Days for Women | This represents the change from baseline in the mean number of drinking days for women. Number drinking days was assessed using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. | Only women were included in this analysis. | Posted | Mean | Standard Error | Drinking days | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
|
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|
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| Secondary | Change in Mean Number of Drinks Per Drinking Day for Women | This represents the change from baseline in the mean number of drinks per drinking day for women. The number of drinks per drinking day was measured using the Timeline Follow-Back at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. | Only women were included in this analysis. | Posted | Mean | Standard Error | Drinks per drinking day | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
|
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| Secondary | Change in Mean Addiction Severity Index Alcohol Composite Score for Women | This represents the change from baseline in mean composite scores of the Addiction Severity Index (ASI) alcohol section. The ASI was administered at baseline (assessing for the 60 days prior to the baseline interview) and then monthly for months 1-6 (months 1-3 were in-treatment assessments and months 4-6 were post-treatment follow-up assessments), and month 9 (also a post-treatment follow-up assessment). We implemented a general mixed model analysis of variance (MMANOVA), which models the means per group over the respective time period and the covariance between the repeated measures over the assessments. Both the in-treatment and post-treatment time frames were compared to baseline substance use data. The ASI is a widely employed multidimensional assessment of substance-related problems. Scores range from 0-1 where higher scores reflect higher addiction severity. | Only women were included in this analysis. | Posted | Mean | Standard Error | units on a scale | In-treatment phase (month 1-3), Post-treatment phase (month 4-6, 9) |
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| Post-Hoc | Client Satisfaction for Women | Participant satisfaction with the groups was assessed using the Client Satisfaction Questionnaire (CSQ-8) plus four additional questions about the helpfulness of the therapist, group content, and group composition. Questions were answered on a 4-point scale where 1 reflected negative feelings and 4 reflected positive feelings. Participants' scores are calculated by adding up the numbers assigned to their chosen answers. Therefore, scores can range between 12 and 48, with higher scores reflecting greater satisfaction. The CSQ was administered at week 3, 6, 9, and 12 while participants were in treatment. Scores represent calculated averages of the group averages for week 3, week 6, week 9, and week 12. | Only women were included in this analysis. | Posted | Mean | Full Range | units on a scale | In treatment phase (week 1-12) |
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| Other Pre-specified | Baseline Substance Use Data for Women | The data reflect baseline characteristics of women participants with respect to (1) days of any substance use (i.e. drugs or alcohol), and (2) the number of drinking days, in the 60 days prior to baseline intake.This data was collected using the Timeline Follow-Back. | Only women were included in this analysis. | Posted | Mean | Standard Error | Days | Baseline |
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| Other Pre-specified | Baseline Drinks Per Drinking Day for Women | The data reflect baseline characteristics of the women participants with respect to the number of drinks per drinking day in the 60 days prior to baseline intake. This was measured using the Timeline Follow-Back. | Only women were included in this analysis. | Posted | Mean | Standard Error | Drinks per drinking day | Baseline |
|
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| Other Pre-specified | Baseline Addiction Severity Index Alcohol Composite Score for Women | The data reflect baseline characteristics of the participants with respect to ASI alcohol composite score. Scores range between 0 and 1. Higher scores reflect higher addiction severity. 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. | Only women were included in this analysis. | Posted | Mean | Standard Error | units on a scale | Baseline |
|
|
|
| 0 |
| 29 |
| 0 |
| 29 |
| 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 of abuse; 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. | 0 | 17 | 0 | 17 |
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