Transdiagnostic Cognitive Remediation Therapy for Patients With Eating Disorders: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- BRIEF-A
研究概览
简要总结
Eating disorders are severe mental illnesses, mainly affecting adolescent- and young adult women. The prognoses for eating disorders are relatively poor, and a large part of patients with these illnesses do not benefit from available conventional therapies. After decades of research into the causes of eating disorders, there is now compelling evidence for specific neuropsychological difficulties in patients affected by eating disorders. These neuropsychological difficulties are characterized by cognitive and behavioral rigidity (poor set-shifting abilities), as well as difficulties related to central coherence, planning and impulse control. Surprisingly, few therapies specifically target these difficulties, and they are rarely incorporated into treatment. Cognitive Remediation Therapy has shown promising results as an adjunctive therapeutic intervention for patients with anorexia Nervosa. The primary aim of this randomized controlled trial is thus to investigate the effect of Cognitive Remediation Therapy on neuropsychological function, symptoms of eating disorders and general mental health, quality of life and motor activity in women with both eating disorders (transdiagnostic) and these specific cognitive difficulties.
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
- 16 Years 至 36 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Being in in-patient-, day- or out-patient treatment for an eating disorder (anorexia nervosa, bulimia nervosa, binge eating disorder or OSFED)
- •Displaying cognitive difficulties (score ≤ -1 standard deviation) on:
- •the Inhibit, Shift, Plan/ Organize and/ or Global Executive Composite indexes of the self-report measure the BRIEF-A (reversed)
- •the Total errors, Perseverative Responses, Perseverative Errors and/ or Learning to learn from the Wisconsin Card Sorting Test (WCST) and/ or on the Rey Complex Figure Test (RCFT) Copy condition or Q-score and/ or on condition 3 and 4 on the Color-word Interference Test from (D-KEFS)
- •Being able to understand and speak Norwegian
- •Be willing to provide written informed consent
- •Accepting random allocation to the two arms of the study
排除标准
- •A history of congenital or acquired brain injury (except concussions)
- •Active substance abuse
- •Psychosis
- •Intelligence quotient (IQ) less than 70
结局指标
主要结局
BRIEF-A
时间窗: 6 month follow-up
Executive function according to the self-report questionnaire the Behaviour Rating Inventory of Executive Function, Adult (BRIEF-A). This questionnaire consist of 75 items on which the patient's symptoms are rated on a 3-point Likert scale. The questionnaire provides a Global Executive Composite score (range 75-225) and two index scores: the Behavioral Regulation Index (range 30-90) and the Metacognitive Index (range 40-120) in addition to nine subscales: Inhibit (range 8-24), Shift (range 6-18), Emotional control (range 10-30), Self-monitor (range 6-18), Initiate (range 8-24), Working memory (range 8-24), Plan/organize (range 10-30), Task monitor (range 6-18) and Organization of materials (range 8-24). Higher scores indicate more executive difficulties.
EDFLIX
时间窗: 6 month follow-up
Mental flexibility is measured according to the self-report questionnaire the Eating Disorder Flexibility Index (EDFLIX). This questionnaire consist of 36 items scored on a 6-point Likert scale. The questionnaire provides a total score (range 36-216) and three index scores: EDFLIX-GF (General Flexibility; range 17-102), EDFLIX-FoEx (Food and Exercise Flexibility; range 13-78) and EDFLIX-WeSh (Weight and Shape Flexibility; range 6-36). Higher scores indicate more flexibility.
EDI-3
时间窗: 6 month follow-up
Eating disorder- and general psychological symptoms according to the Eating Disorder Inventory, 3rd version (EDI-3). EDI-3 consist of 91 items rated on a 6 point Likert scale. The items are organized in to 12 primary scales: Drive For Thinness (range 0-28), Bulimia (range 0 -32), Body Dissatisfaction (range 0-40), Low Self-Esteem (range 0-24), Personal Alienation (range 0-28), Interpersonal Insecurity (range 0-28), Interpersonal Alienation (range 0-28), Interoceptive Deficits (range 0-36), Impulse Disregulation (range 0- 32), Perfectionism (range 0-24), Asceticism (range 0-28) and Maturity Fears (range 0-32). In addition, the EDI-3 also provides 6 composites: Eating Concerns Composite (range 0-100), Ineffectiveness (range 0-48), Interpersonal Problems (range 0- 52), Affective Problems (range 0-62), Overcontrol (range 0-52) and Global Psychological Maladjustment (range 0-252). Higher scores indicates more severe problems.
WCST
时间窗: 6 month follow-up
Mental flexibility as measured by the Wisconsin Card Sorting Test (WCST)
EDE-Q
时间窗: 6 month follow-up
Eating disorder behaviors (binge eating and inappropriate weight compensatory behaviors) and attitudinal features of eating disorders over the previous 28 days is measured by the Eating Disorder Examination (EDE-Q), v. 16.0. The EDE-Q includes 22-attitudinal items that are each rated using seven-point forced-choice format. The items are grouped into four clinically-derived subscales each consisting of five to eight items: Dietary restraint, Eating concern, Weight concern, and Shape concern. The score of each subscale is calculated as the average of item scores within the subscale and yields a range of 0-6. The global score is calculated as the average of the four subscale scores (range 0-6). Higher scores indicates greater pathology.
RCFT
时间窗: 6 month follow-up
Central coherence as measured by the Rey Complex Figure Test (RCFT)
CWIT
时间窗: 6 month follow-up
Inhibition as measured by the Color-Word Interference Test (CWIT)
次要结局
- EDE-Q(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)
- RCFT(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)
- SF-36v2(6 month follow-up)
- CCPT-3(Post-intervention (12 weeks after baseline assessment), 6 month follow-up)
- BDI-II(Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up)
- Actigraphy(6 months)
- BAI(Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up12 weeks (post-treatment))
- EDI-3(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)
- Tower Test(Post-intervention (12 weeks after baseline assessment), 6 month follow-up)
- EDFLIX(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)
- TMT(Post-intervention (12 weeks after baseline assessment), 6 month follow-up)
- IGT(Post-intervention (12 weeks after baseline assessment), 6 month follow-up)
- MCQ-30(Post-intervention (12 weeks after baseline assessment), 6 month follow-up, 2 year follow-up)
- BRIEF-A(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)
- WCST(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)
- CWIT(Post-intervention (12 weeks after baseline assessment), 2 year follow-up)