Ignite Creation Date:
2024-05-06 @ 7:43 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06118346
Status:
RECRUITING
Last Update Posted:
2023-12-21
First Post:
2023-05-31
Brief Title:
A Female-Specific CBT Group for Veteran Women With Alcohol Use Disorder in VA Primary Care Settings
Sponsor:
University of Massachusetts Worcester
Organization:
University of Massachusetts Worcester
Study Overview
Official Title:
A Female-Specific Cognitive Behavioral Therapy Group for Alcohol Use Disorder in VA Primary Care Settings
Status:
RECRUITING
Status Verified Date:
2023-12
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 is to evaluate a Female-Specific Cognitive Behavioral Therapy CBT Group as treatment for Alcohol Use Disorder among Veteran women
Detailed Description:
This is a five year Hybrid Type 1 effectiveness-implementation study For Aim 1 162 female Veterans with AUD will be enrolled over 25 years in the study at Primary Care and Womens Comprehensive Primary Care Clinics ie the Womens Health Clinic in the VA New York Harbor Healthcare System VA NYHHS n162 for a final sample of 140 at 15 month post-baseline ie12 month post treatment follow up The 86 follow up rate is based on Dr Epsteins prior Randomized Control Trial RCT testing FS-CBT for civilian women with AUD on which the current Veteran- Centric FS-CBT group is based After the research baseline interview participants will be randomly assigned to either Usual Care UC which is Brief Alcohol Counseling Referral to Substance Use Disorder SUD Specialty Care if indicated all called Brief Alcohol Counselling BAC and otherwise also known as Brief Intervention and Referral to treatment BIRT or to the 12 session rolling entry group Veteran Female Specific CBT for AUD FS-CBT held within the VA NYHHS Womens Health Clinic Participants in both conditions will complete the same baseline BL 3- 9- and 15-months post-BL ie 0- 6- 12-months after treatment research assessments Primary outcome variables will be treatment access attending least one FS- CBT group session or 1 SUD specialty care session in the FS-CBT condition and at least 1 SUD specialty care session in the usual UC condition treatment engagement is defined as number of treatment hours attended in each condition drinking outcomes percent drinking days and percent heavy drinking days during and 1 year after the treatment phase Secondary outcomes include drug use mental health social support for abstinence and health behaviors For Aim 2 a formative evaluation will be done during the RCT using program process data to track provider interest patient enrollment rates reasons for refusal and treatment adherence
Using an implementation science framework Consolidated Framework for Implementation Research CFIR the investigators will evaluate implementation barriers and facilitators of FS-CBT in VA PC using qualitative interviews with 20 women Veterans in FS-CBT 20 in UC 15 women with AUD who were eligible but did not enroll in the RCT and 16 providersstakeholders The goal of the formative evaluation is to help determine factors at the system provider and patient levels that affect the likelihood that FS-CBT will be successfully implemented and sustained in VA Primary Care PC The evaluation will allow for more rapid translational gains in terms of intervention uptake and sustainability The evaluation will include the systematic collection of quantitative RCT process data eg number and of patient referral opt-outs by Primary Care Providers PCPs of eligible women who enroll reasons for refusal number of group sessions completed by Veteran characteristics and qualitative data via interviews with patient and staff stakeholders To learn about patient-level barriersfacilitators study personnel will conduct interviews with 20 female Veterans who were randomized to the FS-CBT condition and 20 who were randomized to UC a one-half will be drawn from those who completed the full dose 12 sessions in FS-CBT and all treatment recommendations in UC and the other half from those who dropped out and completed less than the recommended minimal dose Investigators will sample from participants who significantly reduced their drinking and from those who did not Investigators will include a diverse sample of Veterans based on age gender raceethnicity era of military service and diagnoses eg PTSD Lastly study personnel will interview 15 women with AUD who were eligible but did not enroll in the RCT to understand their perceptions of the program and barriers to participation
The CFIR framework will be used to guide the interview approach CFIR is a typology of 39 constructs from five main domains that identify factors associated with successful implementation and maintenance of health care innovations 1 Intervention Characteristics 2 Inner Setting 3 Outer Setting Characteristics of Individuals 5 Process If Aim 1 hypotheses are supported these interviews will help guide subsequent implementation trials of FS-CBT by explaining a barriers and facilitators to participation perceptions about why FS-CBT is successful at achieving better outcomes for women Veterans with AUD the barriers and facilitators to high fidelity implementation of FS-CBT and the sustainability of FS-CBT in the absence of a funded research project and how to achieve this goal and b how FS-CBT should be adjusted to appeal to the subgroup of Veterans If Aim 1 hypotheses are not supported the interviews will determine the reasons why ie questions posed to staff and patients will solicit information on barriers associated with delivery of FS-CBT during the RCT and what modifications to FS-CBT could be made to maximize effectiveness
Using an implementation science framework Consolidated Framework for Implementation Research CFIR the investigators will evaluate implementation barriers and facilitators of FS-CBT in VA PC using qualitative interviews with 20 women Veterans in FS-CBT 20 in UC 15 women with AUD who were eligible but did not enroll in the RCT and 16 providersstakeholders The goal of the formative evaluation is to help determine factors at the system provider and patient levels that affect the likelihood that FS-CBT will be successfully implemented and sustained in VA Primary Care PC The evaluation will allow for more rapid translational gains in terms of intervention uptake and sustainability The evaluation will include the systematic collection of quantitative RCT process data eg number and of patient referral opt-outs by Primary Care Providers PCPs of eligible women who enroll reasons for refusal number of group sessions completed by Veteran characteristics and qualitative data via interviews with patient and staff stakeholders To learn about patient-level barriersfacilitators study personnel will conduct interviews with 20 female Veterans who were randomized to the FS-CBT condition and 20 who were randomized to UC a one-half will be drawn from those who completed the full dose 12 sessions in FS-CBT and all treatment recommendations in UC and the other half from those who dropped out and completed less than the recommended minimal dose Investigators will sample from participants who significantly reduced their drinking and from those who did not Investigators will include a diverse sample of Veterans based on age gender raceethnicity era of military service and diagnoses eg PTSD Lastly study personnel will interview 15 women with AUD who were eligible but did not enroll in the RCT to understand their perceptions of the program and barriers to participation
The CFIR framework will be used to guide the interview approach CFIR is a typology of 39 constructs from five main domains that identify factors associated with successful implementation and maintenance of health care innovations 1 Intervention Characteristics 2 Inner Setting 3 Outer Setting Characteristics of Individuals 5 Process If Aim 1 hypotheses are supported these interviews will help guide subsequent implementation trials of FS-CBT by explaining a barriers and facilitators to participation perceptions about why FS-CBT is successful at achieving better outcomes for women Veterans with AUD the barriers and facilitators to high fidelity implementation of FS-CBT and the sustainability of FS-CBT in the absence of a funded research project and how to achieve this goal and b how FS-CBT should be adjusted to appeal to the subgroup of Veterans If Aim 1 hypotheses are not supported the interviews will determine the reasons why ie questions posed to staff and patients will solicit information on barriers associated with delivery of FS-CBT during the RCT and what modifications to FS-CBT could be made to maximize effectiveness
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AA028240-01A1 | NIH | None | httpsreporternihgovquickSearch1R01AA028240-01A1 |