跳至主要内容
临床试验/NCT01035788
NCT01035788已完成不适用

Effects of Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD and Relationship Function

VA Office of Research and Development1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2010年7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
入组人数
92
试验地点
1
主要终点
Clinician-Administered PTSD Scale (CAPS)

研究概览

简要总结

The purpose of this study is to first adapt Cognitive Behavioral Conjoint Therapy for PTSD for Operation Enduring Freedom and Operation Iraqi Freedom (OEF-OIF) Veterans diagnosed with PTSD and their intimate partners by (1) reducing the overall length of treatment from 15 weeks to 10 weeks through the use of a weekend couple retreat to deliver the first two of three phases of the three-phase protocol; and (2) by integrating mindfulness interventions as a way to mitigate the short, more condensed treatment. Secondly, this study will examine the effects of this adapted Mindfulness-Based Cognitive-Behavioral Conjoint Therapy on PTSD symptoms and intimate relationship functioning.

详细描述

Between 5 and 15 percent of Veterans return from deployment in Iraq and Afghanistan with PTSD and the symptoms adversely affect many aspects of their lives, including intimate relationships. Although research findings consistently suggest that the degree of intimate relationship dysfunction correlates with the severity of Veteran's PTSD symptoms, few couples interventions have been developed and systematically evaluated. Cognitive Behavioral Conjoint Therapy for PTSD (CBCT for PTSD) is an intervention developed to treat both PTSD and relationship dysfunction that has shown promising preliminary results. However, the literature suggests that OEF-OIF Veterans prefer shorter time-limited treatments and CBCT for PTSD requires as many as 15 sessions. CBCT for PTSD lacks specific interventions that train meta-awareness, such as those taught in mindfulness-based stress reduction (MBSR). Mindfulness practices have an emerging evidence base for improving both PTSD and relationship functioning in several important ways. First, practicing mindfulness promotes the relaxation response which counters hyperarousal and results in a calmer approach to difficulties and challenges. Second, avoidance and numbing are countered by mindfully allowing one's experience to be as it is while suspending judgment, which is associated with increased compassion and empathy. Lastly, mindfulness supports a way of being with all life experiences rather than providing techniques just for coping with specific difficulties, which enables individuals to access inner strengths that are already available to them. Just as many physical conditions require more than one rehabilitation approach, there may be a synergy between CBCT for PTSD and mindfulness interventions. Mindfulness skills may assist individuals in tolerating painful emotional reactions to their experiences which may in turn enhance their awareness of associated feelings and thoughts. With enhanced meta-awareness the beliefs that may maintain PTSD symptoms and relationship dysfunction become more amenable to cognitive restructuring. Therefore, the goal of this study is to examine the effects of a Mindfulness-Based adaptation of CBCT for PTSD. The study involves two phases over the course of four years. In Phase 1, mindfulness interventions will be integrated within the Cognitive Behavioral Conjoint Therapy for PTSD treatment manual and the content of the first 7 sessions of CBCT will be adapted to be delivered during a weekend retreat. The integrated intervention, MB-CBCT for PTSD, will be delivered to 10 OIF-OEF Veterans and each of their intimate partners in order to develop and test procedures to train and monitor therapists. During Phase 2, 40 OEF-OIF Veterans and each of their intimate partners will be consented and a randomized controlled trial with be conducted comparing the MB-CBCT for PTSD with a control condition that teaches communication skills drawn from the first 7 sessions of the CBCT manual. We hypothesize that MB-CBCT for PTSD will lead to greater improvement in: 1) Veterans' PTSD symptoms as measured by the Clinician Administered PTSD Scale (primary outcome) and PTSD Checklist (secondary outcome); 2) Veterans' and partners' relationship functioning (secondary outcome); and 3) anxiety and depression symptoms (secondary outcomes). PTSD constitutes a substantial proportion of the burden of illness among Veterans. The longer term goals of this project are to conduct a fully-powered randomized controlled clinical trial of MB-CBCT to determine its effectiveness and to finalize the treatment manual.

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)

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

  • •Veteran must:
  • •be enrolled in outpatient treatment
  • •have a confirmed diagnosis of PTSD
  • •have no major change in psychiatric medication for at least 1 month
  • •have a partner mutually committed to maintaining the relationship for the duration of the intervention
  • •willing to forgo initiating psychotherapy for PTSD or other conditions during the study

排除标准

  • •severe physical or sexual relationship aggression in the past year
  • •current suicidal/homicidal intent (Veteran or partner)
  • •cognitive impairment that precludes understanding session content (either Veteran or partner)
  • •current substance dependence of Veteran or partner
  • •uncontrolled psychotic or bipolar disorder in Veteran or partner
  • •PTSD diagnosis in the partner
  • •self-mutilation or self-injury within the previous 6 months by Veteran or partner
  • •unwilling to have therapy or CAPS sessions video or audio recorded

研究组 & 干预措施

Mindfulness-Based CBCT

Experimental

Mindfulness Based Cognitive Behavioral Conjoint Therapy for PTSD

干预措施: Mindfulness Based Cognitive Behavioral Conjoint Therapy (Behavioral)

CBCT Communication Skills

Active Comparator

CBCT for PTSD - Communication Skills

干预措施: CBCT for PTSD - Communication Skills (Behavioral)

结局指标

主要结局

Clinician-Administered PTSD Scale (CAPS)

时间窗: treatment end (approximately 10 weeks after session 1 of the interventions)

The Clinician Administered PTSD Scale (CAPS; Blake et al., 1995) is a semi-structured interview that evaluates PTSD symptoms and diagnostic status according to the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (APA, 2000). The intensity and frequency of each symptom is separately on a 5 point Likert scale ranging from zero to four. The total CAPS symptom severity score ranges from 0-136, with higher scores indicating greater PTSD symptoms severity. For the purposes of this study, a score of 45 or greater confirmed a diagnosis of PTSD.

次要结局

未报告次要终点

研究者

申办方类型
Fed
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验