Ignite Creation Date:
2024-05-06 @ 11:43 AM
Last Modification Date:
2024-10-26 @ 12:49 PM
Study NCT ID:
NCT03589274
Status:
COMPLETED
Last Update Posted:
2018-07-17
First Post:
2018-06-08
Brief Title:
Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
Sponsor:
Rutgers The State University of New Jersey
Organization:
Rutgers The State University of New Jersey
Study Overview
Official Title:
Testing CBT Models and Change Mechanisms for Alcohol Dependent Women
Status:
COMPLETED
Status Verified Date:
2018-07
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:
WTPIII
Brief Summary:
The study has 4 specific aims 1 To modify our existing Individual Female Specific Cognitive Behavioral Therapy I-FS-CBT for Alcohol Use Disorder AUD approach to treat women with alcohol dependence in a group format Group Female Specific Cognitive Behavioral Therapy G-FS-CBT 2 To test the relative efficacy of I-FS-CBT and G-FS-CBT 3 To test hypothesized mechanisms of change in drinking that are common to both treatments including a coping skills and enhanced self-efficacy for abstinence b enhanced sense of autonomy c alleviation of negative affect and d increased social network support for abstinence and 4 To assess the relative cost-effectiveness of the individual and group treatment
Detailed Description:
Participants completed a telephone screen for initial eligibility and were scheduled for an in-person clinical intake interview Consented women were scheduled for a baseline research interview BL approximately one week later At the end of the BL participants were randomized to treatment condition During the 12 session treatment period women completed assessments at the beginning and end of each therapy session on secondary outcome and therapy process variables
In I-FS-CBT each participant saw a therapist weekly The first session was 90 minutes long and subsequent sessions were 60 minutes long The I-FS-CBT manual included core CBT motivational enhancement and relapse prevention components Two core thematic womens issues were integrated into each session via discussion and illustrative material a self-confidence and b self-care
The G-FS-CBT manual included material identical to I-FS-CBT but the session organization was modified for a closed group format The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence The first session of G-FS-CBT was 2 hours remaining sessions were 90 minutes
In-person follow-up interviews were done at 3 9 and 15 months post-session 1
In I-FS-CBT each participant saw a therapist weekly The first session was 90 minutes long and subsequent sessions were 60 minutes long The I-FS-CBT manual included core CBT motivational enhancement and relapse prevention components Two core thematic womens issues were integrated into each session via discussion and illustrative material a self-confidence and b self-care
The G-FS-CBT manual included material identical to I-FS-CBT but the session organization was modified for a closed group format The group treatment was designed to provide didactic presentation of coping skills and motivational enhancement material and group discussion and rehearsal of new skills within a supportive atmosphere that facilitated mutual emotional support and support for abstinence The first session of G-FS-CBT was 2 hours remaining sessions were 90 minutes
In-person follow-up interviews were done at 3 9 and 15 months post-session 1
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None