Co-occurring Eating Disorders and Posttraumatic Stress Disorder: Facilitating Full and Sustained Recovery Through Empirically-Based Concurrent Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 2
- 主要终点
- Change in clinician-assessed PTSD symptoms
研究概览
简要总结
Although psychotherapy for eating disorders (EDs) can be effective, approximately 50% of those who complete a course of the best available therapy continue to have significant ED symptoms at the end of treatment. Posttraumatic stress disorder (PTSD) commonly co-occurs with EDs and is thought to be one reason why some individuals do not remit from their ED with best available treatment or relapse following treatment. In particular, ED behaviours can function as coping methods for PTSD symptoms, and thus interfere with successful and lasting ED recovery. The main objective of this initial treatment trial is to determine whether a concurrent treatment approach, in which PTSD symptoms are treated at the same time as ED symptoms, provides an advantage over standard ED treatment by successfully alleviating PTSD symptoms.
Forty participants who have both an ED and PTSD will be assigned to receive either (1) standard ED psychotherapy alone or (2) standard ED psychotherapy concurrent with PTSD psychotherapy. After treatment, participants will be followed for a period of 6 months to determine whether improvements made during therapy are maintained after treatment. ED and PTSD symptoms, as well as concomitant symptoms (e.g., anxiety and depression) will be assessed immediately before and after treatment, as well as 3 and 6 months after treatment.
详细描述
Standard ED treatment is characterized by partial response in many individuals, and the risk of relapse is high. This, in combination with significant rates of comorbid PTSD, evidence that trauma history can negatively impact ED treatment outcome, and the observation that PTSD may be a central ED maintaining factor in these individuals, has led us to develop a program of research aimed at demonstrating that the alleviation of PTSD symptoms concurrent with ED treatment facilitates a fuller and sustained ED recovery for these individuals.
The specific aims of this initial randomized controlled trial (RCT) are to determine: (1) the immediate and short-term efficacy of concurrent evidence-based ED and PTSD treatment in reducing PTSD symptoms relative to standard ED treatment; and (2) estimates of the effect sizes of concurrent treatment on ED symptomatology relative to standard ED treatment at post-treatment and follow-up.
Primary Hypothesis:
- Concurrent CBT for ED and PTSD will result in significantly greater improvements in clinician-rated PTSD symptoms at post-treatment, as well as at 3- and 6-month follow-up compared with CBT for ED alone.
Secondary Hypotheses: 2. Concurrent CBT for ED and PTSD will result in significantly greater improvements in self-reported PTSD symptoms at post-treatment, as well as at 3- and 6-month follow-up compared with CBT for ED alone. 3. Concurrent CBT for ED and PTSD will result in significantly greater improvements in concomitant symptoms (e.g., anxiety and depression) at post-treatment, as well as at 3- and 6-month follow-up compared with CBT for ED alone.
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
- 17 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •have had a minimum dose of intensive eating disorder treatment in the Toronto General Hospital Eating Disorder Program, defined as 6 weeks or longer
- •have current Diagnostic and Statistical Manual of Mental Disorders-5 (DSM-5) diagnoses of an eating disorder and PTSD
- •be on a stable (or no) psychotropic medication regimen for at least 4 weeks
排除标准
- •current body mass index less than 18.5
- •current substance use disorder involving dependence
- •current psychosis
- •current bipolar episode
- •medical treatment or other condition known to influence eating and/or weight
- •current participation in another psychosocial treatment for ED or trauma
- •current participation in any treatment study for ED or trauma
- •has previously received cognitive processing therapy for PTSD
结局指标
主要结局
Change in clinician-assessed PTSD symptoms
时间窗: pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up
Change in PTSD symptoms will be assessed using the Clinician-Administered PTSD Scale (CAPS; Weathers et al., 2013). Scores range from 0-80 with a higher score representing higher severity.
次要结局
- Change in depression(pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up)
- Change in self-reported PTSD symptoms(pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up)
- Change in anxiety(pre-treatment, end of treatment (after approximately 14 weeks), 3- and 6-month follow up)
研究者
Kathryn Trottier
Staff Psychologist
University Health Network, Toronto