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临床试验/NCT03589521
NCT03589521已完成不适用

Adapting Alcohol Behavioral Couple Therapy for Service Members in Post-Deployment

University of Massachusetts, Worcester2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2015年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
2
主要终点
Percent Drinking Days (PDD)

研究概览

简要总结

The specific aims of the ABCT_Military project are as follows: 1) To modify the existing, Alcohol Behavioral Couple Therapy (ABCT) model to treat service members in the reconstitution (post deployment, reintegration, or separation) stage of service, and develop optional psychoeducation modules to address relevant co-morbid problems and challenges in this population in a weekly, 15 session, stand-alone outpatient format. 2) To test feasibility and preliminary efficacy of the study intervention protocol in a successive cohort design for one cohort of 8 couples and one cohort of 22 couples, with iterative manual revision.

详细描述

The study staff will screen potential participants over the phone, and arrange Baseline (BL) research interviews for appropriate couples. The couple will meet with the program interviewer for approximately 2 hours. After the BL interview, couples will be scheduled to attend therapy sessions. Couples will complete brief within treatment self-report assessments. Couples will complete a post treatment follow up interview four months after session 1.

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

入选标准

  • Age 18 and older;
  • Married (or separated with efforts to reconcile) or in a committed relationship (cohabiting, or in an exclusive dating relationship), or significant other (SO) (first, second or third degree relative (including step relative or in-law) or close trusted friend not active in same military branch. The service member only must meet the following inclusion criteria:
  • Served or serving in the U.S. Military,
  • Current Alcohol Use Disorder diagnosis, or drink at high risk levels as defined by NIAAA (2010)

排除标准

  • Either individual is not fluent in the English language.
  • Exclusion criteria for the service member only:
  • Unstabilized Psychotic disorder in past six months
  • Exclusion criteria for both members of the couple if SO is spouse/romantic partner:
  • Either partner is fearful of participating in couple therapy OR either partner suffered severe physical abuse from partner when perpetrator not intoxicated, in past year

研究组 & 干预措施

ABCT_Military

Experimental

ABCT_Military manual will address alcohol use, couple issues and military specific issues. Required interventions include: routine interventions, overview of treatment, reintegration issues, motivational techniques, patient-focused interventions for abstinence, partner-related interventions for abstinence, couple interventions, general coping skills, social skills and relapse prevention. In addition, to personalize each treatment plan, interventions from optional modules (e.g., intimate partner violence (IPV), depression, trauma, and traumatic brain injury (TBI)) will be integrated into each couple's treatment plan depending on clinical presentation.

干预措施: ABCT_Military (Behavioral)

结局指标

主要结局

Percent Drinking Days (PDD)

时间窗: Change from baseline at 4 months post Session 1

Derived from Timeline Followback (TLFB)

Percent Heavy Drinking Days

时间窗: Change from baseline at 4 months post Session 1

Derived from Timeline Followback (TLFB)

Mean Drinks Per Drinking Day

时间窗: Change from baseline at 4 months post Session 1

Derived from Timeline Followback (TLFB)

Couple Satisfaction Inventory 16

时间窗: Change from baseline at 4 months post Session 1

16 item measure assessing satisfaction in couple relationship. Scores range from 0 to 81 and higher scores indicate higher levels of relationship satisfaction. Total score is calculated by summing all values.

次要结局

  • Coping Strategies Scale(Change from baseline at 4 months post Session 1)
  • World Health Quality of Life Questionnaire - Bref(Change from baseline at 4 months post Session 1)
  • Treatment Services Review(Weekly during treatment, for up to 16 weeks)
  • Working Alliance Inventory Short Form(Baseline and through study completion, about 16 weeks)
  • Post-Traumatic Stress Disorder (PTSD)(Baseline)
  • PTSD Checklist (PCL-5)(Baseline and through study completion, about 16 weeks)
  • Use of Treatment Skills(Baseline and through study completion, about 16 weeks)

研究者

发起方
University of Massachusetts, Worcester
申办方类型
Other
责任方
Principal Investigator
主要研究者

Elizabeth Epstein

Professor

University of Massachusetts, Worcester

研究点 (2)

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