Randomized Controlled Trial of Intensive Multi-Couple Therapy for PTSD Versus Relationship Education in Military Couples
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Clinician-Administered PTSD Scale for DSM-5
研究概览
简要总结
The goal of this clinical trial is to test an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD (AIM-CBCT for PTSD) in an active military and veteran population. The main questions it aims to answer are:
- Does AIM-CBCT for PTSD improve PTSD symptoms?
- Does AIM-CBCT for PTSD improve associated symptoms (e.g., depression), romantic partner distress, and couple relationship satisfaction?
Participants will participate in a two-day retreat in which they are taught and practice skills to decrease PTSD symptoms and enhance their relationships. Researchers will compare AIM-CBCT for PTSD to the Prevention and Relationship Education Program (PREP) to determine whether it is superior to an evidence-based relationship education curriculum that is also delivered in a two-day multi-couple group format.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Independent evaluators will be blinded as to participant treatment condition during follow-up assessments.
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
- •Service member or veteran and a romantic partner willing to participate.
- •Couple is married or cohabiting for at least 3 months. Couple can be either different or same sex.
- •Service member/veteran diagnosis of PTSD as determined by the CAPS-
- •Each partner is at least 18 years old.
- •Both partners able to speak and read English.
排除标准
- •Either partner reports current suicidal ideation severe enough to warrant immediate attention
- •Current homicide risk meriting crisis intervention for either partner
- •Current and severe alcohol misuse in either partner warranting immediate intervention
- •Symptoms of moderate to severe other substance use warranting immediate intervention
- •Recent (past month) manic episode or psychotic disorder symptoms in either partner
- •Other psychiatric disorders severe enough to warrant designation as the primary disorder
- •Evidence of a moderate or severe traumatic brain injury or other cognitive impairment in either partner
- •Couple is separated or have taken steps to dissolve their relationship
- •Either partner is currently participating in evidence-based treatment for PTSD (e.g., Prolonged Exposure, Cognitive Processing Therapy, Present-Centered Therapy for PTSD, Eye Movement Desensitization and Reprocessing, Cognitive-Behavioral Conjoint Therapy for PTSD, or Structured Approach Therapy).
- •Evidence or admission of severe intimate aggression by either partner occurring within the past 6-months.
研究组 & 干预措施
Prevention and Relationship Education Program
PREP is an evidence-based relationship education program delivered in a multi-couple group format.
干预措施: Prevention and Relationship Education Program (Behavioral)
Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD
AIM-CBCT for PTSD is an abbreviated, intensive, multi-couple group version of cognitive-behavioral conjoint therapy for PTSD, an evidence-based treatment for PTSD delivered in a conjoint format.
干预措施: Abbreviated, Intensive, Multi-Couple Group Cognitive-Behavioral Conjoint Therapy for PTSD (Behavioral)
结局指标
主要结局
Clinician-Administered PTSD Scale for DSM-5
时间窗: baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up
Interviewer ratings of posttraumatic stress disorder (PTSD) symptoms identified in the Diagnostic and Statistical Manual for Mental Disorders, Fifth Edition. Scores range from 0-80, with higher scores indicating more severe PTSD symptoms.
次要结局
- PTSD Checklist for DSM-5(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
- Dimensions of Anger Reactions-5(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
- Couples Satisfaction Index-32(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
- Patient Health Questionnaire-9(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
- Generalized Anxiety Disorder-Screener(baseline, 1-month follow-up, 3-month follow-up, 6-month follow-up)
研究者
Steffany J Fredman, Ph.D.
Associate Professor of Human Development and Family Studies and Psychology
Penn State University