Ralph H. Johnson VA Medical Center, Charleston, SC
Charleston, South Carolina, 29401-5703, United States
NCT Number: NCT07388654
Treatment of post-traumatic stress disorder (PTSD) and alcohol use disorder (AUD) treatment for Veterans is challenging for Veterans. Veterans often benefit from social support from friends and loved ones while in treatment; however, the symptoms of PTSD and AUD often are associated with increased relationship conflict. It is essential to identify new ways to improve PTSD-AUD treatment, and involving loved ones in the process may be a way to improve treatment.
The purpose of this study is to pilot test a brief couples intervention that is designed to be delivered while Veterans are in treatment for PTSD-AUD. Over the course of 12 weeks, Veterans will receive individual treatment through Concurrent Treatment of PTSD and Substance Use Disorders with Prolonged Exposure (COPE), and Veterans and their romantic partners will attend 3-4 sessions of Brief Family Involved Treatment (B-FIT) which has been modified specifically for Veterans with PTSD-AUD. Veterans and their romantic partners will complete a baseline visit, 12 weeks of weekly measures, and a 3-month follow-up visit. This is a stage 1a one-armed non-randomized pilot trial.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Early Phase 1
Charleston, South Carolina, 29401-5703, United States
Co-occurring PTSD-AUD is a complex and urgent public health crisis. COPE is a highly efficacious integrated intervention that has strong positive effects on reducing PTSD symptoms, but has substantial room for improvement regarding AUD outcomes. Adapting a brief dyadic intervention designed to target AUD to be delivered alongside COPE (COPE + B-FIT) is a promising way to bolster AUD outcomes and increase relationship functioning to promote recovery for Veteran and their families. The present study will test a modified version of B-FIT that is specifically designed to be delivered to Veterans with PTSD-AUD and their romantic partners. The goals of B-FIT are to: 1. increase reinforcement for AUD treatment engagement, 2. increase positive rewards from drinking reductions, and 3. decrease drinking cues by decreasing negative communication and increasing positive communication. This trial will recruit Veterans and their romantic partners (N=40 couples/80 individuals). This Stage 1a/1b trial will look at primary outcomes of feasibility and acceptability of the adapted B-FIT intervention, and secondary outcomes of PTSD symptoms, AUD symptoms, and psychosocial functioning.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Inclusion criteria
for Veterans and Significant Others:
Additional inclusion criteria for the Veteran patient:
Exclusion criteria
Veterans will engage in 12 sessions of COPE individually, and Veterans and their significant others will participate in in 3-4 sessions of the adapted B-FIT intervention specifically for Veterans with PTSD + AUD and their partners. COPE will be delivered concurrently with the adapted B-FIT.
Other names: Concurrent Treatment of PTSD and Substance Use Disorder with Prolonged Exposure and Brief Family Involved Treatment
Time frame: at 12 weeks
Veterans and Significant Others will report on their satisfaction with the adapted B-FIT intervention using the Customer Satisfaction Questionnaire (CSQ). Scores range from 1-4 and higher scores are indicative of greater satisfaction.
Time frame: Baseline to 12 weeks
Feasibility of the adapted B-FIT intervention will be measured by number of sessions attended by each participant.
Time frame: Baseline to 12 weeks
Change in drinks per drinking day, as measured by the Alcohol Timeline Followback (TLFB).
Time frame: Baseline to 12 weeks
Change in PTSD symptoms as measured by the PTSD Checklist (PCL-5). Scores range from 0-80 and higher scores are indicative of greater symptom severity.
Time frame: Baseline to 12 weeks
Change in Alcohol problem severity as measured by the Alcohol Use Disorders Identification Test (AUDIT). Scores range from 0-40 with higher scores indicative of greater alcohol problem severity.
Time frame: Baseline to 12 weeks
Change in relationship satisfaction as measured by the brief Dyadic Adjustment Scales -7 (DAS-7). Scores range from 0-36, with higher scores indicating more positive relationship quality.
Time frame: Baseline to 12 weeks
Change in quality of life as measured by the Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q-SF). Scores range from 14-70 with higher scores indicating greater quality of life.
Time frame: Baseline to 12 weeks
Change in psychosocial functioning in relation to PTSD as measured by the Brief Inventory of Psychosocial Functioning (B-IPF). Scores range from 0-600 with higher scores indicating greater difficulty in psychosocial functioning.
Contact information is provided by the study sponsor or research team.
VA Office of Research and Development
Fed
Adapting a Brief Dyadic Intervention for Co-occurring Post-Traumatic Stress Disorder and Alcohol Use Disorder
Acronym: PACT-V
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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