Ignite Creation Date:
2024-05-05 @ 12:04 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00230100
Status:
COMPLETED
Last Update Posted:
2023-11-01
First Post:
2005-09-29
Brief Title:
The Womens Recovery Group Study Stage I Trial
Sponsor:
Mclean Hospital
Organization:
Mclean Hospital
Study Overview
Official Title:
Recovery Group for Women With Substance Use Disorders - Stage I
Status:
COMPLETED
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
This Phase I trial compares single-gender Womens 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 Womens 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
The treatment manual for a Womens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01DA015434 | NIH | None | httpsreporternihgovquickSearchR01DA015434 |