Adapting a Brief Dyadic Intervention for Co-occurring Post-Traumatic Stress Disorder and Alcohol Use Disorder
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria for Veterans and Significant Others:
- •Any gender or sexual identity; any race or ethnicity
- •Married, cohabiting for at least 6 months, or in a committed relationship for at least 6 months and both partners are willing to participate.
- •The Veteran meets current or past-year DSM-5 diagnostic status for both PTSD (assessed via CAPS-5) and AUD (assessed via the Quick Structured Clinical Interview for DSM-5)
- •Concurrent substance use disorders are acceptable provided that alcohol is the Veteran's primary substance of choice
- •Must demonstrate cognitive functioning sufficient to provide informed consent and participate accurately (=>26 on the Mini-Mental State Exam [MMSE])
- •Participants taking psychotropic medications will be required to be maintained on a stable dose for at least 4 weeks before study initiation
- •Not currently enrolled in couple therapy
- •Additional inclusion criteria for the Veteran patient:
- •U.S. military Veteran
- •Enrolled, or is willing to become enrolled, in VA healthcare
- •Not attending trauma-focused therapy during the intervention period
排除标准
- •History of moderate, severe, or unilateral violence in the relationship in the past year as measured by the CTS-2
- •Either partner demonstrates a need for a higher level of care as assessed by the Quick Structured Clinical Interview for DSM-5 Disorders (QuickSCID)
- •i.e., history of or current psychotic or bipolar disorders, current severe drug use disorder, or concerns about alcohol withdrawal as demonstrated by a score >8 on the CIWA-Ar)
- •Either partner reports current suicidal or homicidal ideation and intent or prior intent or attempt in the past 6 months as assessed by the CSSRS and PHQ-9 item 9
- •The Veteran's SO cannot have substance use problems as indicated by a score < 8 on the AUDIT and QuickSCID
研究组 & 干预措施
COPE + BFIT
In this single arm study, participants will be assigned only to the pilot intervention of COPE + B-FIT.
干预措施: COPE + BFIT (Behavioral)
结局指标
主要结局
Acceptability of Intervention to Participants (Customer Satisfaction Questionnaire)
时间窗: 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.
Feasibility of Intervention (Number of Sessions Attended)
时间窗: Baseline to 12 weeks
Feasibility of the adapted B-FIT intervention will be measured by number of sessions attended by each participant.
次要结局
- Drinks per Drinking Day (Alcohol Timeline Followback (TLFB))(Baseline to 12 weeks)
- PTSD Symptoms (PTSD Checklist (PCL-5)(Baseline to 12 weeks)
- Alcohol Problem Severity (Alcohol Use Disorders Identification Test (AUDIT))(Baseline to 12 weeks)
- Relationship Satisfaction (Dyadic Adjustment Scales -7 (DAS-7))(Baseline to 12 weeks)
- Quality of Life (Quality of Life Enjoyment and Satisfaction Scale (Q-LES-Q-SF))(Baseline to 12 weeks)
- Interpersonal Functioning (Brief Inventory of Psychosocial Functioning (B-IPF))(Baseline to 12 weeks)