CBT-E vs CBT-F+Metacognitive Interpersonal Therapy for Non-underweight Adults With Eating Disorders: Study Protocol for a Pilot Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)
研究概览
简要总结
Eating disorders (ED) are severe but treatable conditions, but there are large margin for improvements in terms of efficacy and adherence. There is room to explore new treatment options who are either more capable to retain patients in therapy, more effective. Alternative their efficacy may match the ones of current available treatments but offer new options to ones that did not respond to available therapies. Here the investigators explored if a combination of CBT-focused plus Metacognitive Interpersonal Therapy (MIT) is an empirically supported therapy for personality disorders and could be a new viable treatment option for non-underweight ED. MIT targets some aspects of ED such as poor awareness of mental states and maladaptive interpersonal schemas that are not included in the transdiagnostic model underlying the most investigated empirically supported treatment for ED that is CBT-E. It is reasonable therefore that targeting these aspects of psychopathology can be a path to treatment adherence and effectiveness
详细描述
The study is a pilot randomized controlled trial that aims to evaluate the feasibility and effectiveness of weekly MIT in addiction to CBT-F in a group of adults diagnosed with ED. Specifically, the investigators will investigate in a sample of non-underweight adults presenting with ED whether once compared to CBT-E, a treatment combining MIT and CBT-F is a) feasible, b) well-tolerated and c) potentially effective on eating disorders symptoms and other outcomes.
The investigators expect that the experimental group CBT-F+MIT would be able to have high treatment adherence and retention on the ground of previous studies of MIT for personality disorders. They will also expect good outcomes in the primary outcome. Given the small sample this is just a pilot study so any conclusions about other outcomes will be considered preliminary. Results will provide new evidence that may lead to consider CBT-F+MIT a treatment option for ED deserving investigations in larger trials.
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
Each participant will be randomized in one of the two experimental conditions by allocation concealment. In particular, randomized-permuted blocks will be used. The research team will be also blind to the randomized allocation. Group allocation will remain concealed until the end of the assessment stage.
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
- •ED diagnosed in the past 6 months
- •Seeking treatment for eating disorder
- •Able to provide written, informed consent
- •BMI > 18.5
排除标准
- •Acute psychotic episode, psychotic symptoms, Bipolar I disorder; antisocial personality disorder
- •Suicidal ideation
- •Substance abuse
- •Previous psychological intervention for other eating disorders
- •Currently involved in other ongoing treatment
研究组 & 干预措施
CBT-E
Participants in the CBT-E condition will receive a total of 20 CBT-E sessions over 20 weeks. CBT-E treatment will consist of four stages. In particular, CBT aims to inform patients about the importance of self-control, the dangers of some restrictive behaviors such as self-induced vomiting. Moreover, CBT provides strategies to patients in order to monitor their usually dysfunctional behaviors and so increasing their awareness (i.e. food diary method) while reducing the availability of food and encourages activities that are incompatible with overeating. Patients will be trained in problem solving in order to change these feelings, as well as in increasing their self-awareness in order to recognize irrational thoughts about their body weight and shape. Additionally, they will be gradually exposed to foods that they had been avoiding.
干预措施: CBT-E (Other)
CBT-F+MIT
Participants in the CBT-F+MIT condition will receive a total of 20 sessions over 20 weeks. Specifically, 2 sessions will be based on CBT-F as usual only. During these sessions participants will receive psychoeducational training on eating behaviors and an introduction to the protocol tools, namely the monitoring form, weight chart, transdiagnostic formulation and Eating Problem Check List (EPCL).
These elements will be used at the beginning of the remaining 18 sessions, in order to monitor the regulations of eating behaviors as well eliciting narrative episodes. These materials will form the basis for the MIT-part of the session, in which therapists will seek to form with the patient a shared understanding of the psychological reasons underlying their ED symptoms and their maladaptive interpersonal functioning. MIT sessions will be integrated within the CBT-F protocol which will provide psycho-educational, nutritional re-education and management for ED.
干预措施: CBT-F+MIT (Other)
结局指标
主要结局
Eating Attitude Test (EAT-26; Garner & Garfinkel, 1979)
时间窗: Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
A self-report measure for identifying the presence of "eating disorder risk" based on attitudes, feelings and behaviors related to eating. It assesses general eating behaviour and risky behaviours.
Binge Eating Scale (BES; Gormally et al., 1992)
时间窗: Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
a self-report questionnaire of the behavioral, cognitive and emotional features of objective binge eating (OBE).
Eating Disorder Examination Questionnaire (EDE-Q6; Fairburn & Beglin, 1994)
时间窗: Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
A self report measure assessing eating disorders over the past 4 weeks, providing a measure of the range of severity of eating disorder features.
Clinical Impairment Assessment Questionnaire (CIA 3.0; Bohn and Fairburn, 2008).
时间窗: Change from baseline until after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.
a self-report measure f assessing the severity of psychosocial impairment due to eating disorder features over the past 28 days.
次要结局
- State-Trait Anxiety Inventory (STAI; Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983)(At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.)
- Beck Depression Inventory (BDI; Beck, et al., 1961)(At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.)
- Symptom Check List (SCL-90)(At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.)
- Difficulties in Emotion Regulation Scale (DERS; Gratz & Roemer, 2004)(At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.)
- Working Alliance Inventory-Short Revised (WAI; SR Hatcher & Gillaspy, 2006)(Every 4 weeks)
- Toronto Alexithymia Scale (TAS - 20; Taylor & Bagby, 1992)(At baseline, after 10 sessions, at the end of the treatment and in the following 3, 6, 12, 18 and 24 months after the treatment.)
- Structured Clinical Interview for DSM-5 Disorders (SCID-5; Michael B. First, Janet B.W. Williams)(At baseline)
研究者
GLORIA FIORAVANTI
Psychotherapist
Centro Trattamento Integrato: Disturbi Alimentari e Obesita