Efficacy and Acceptability of Augmenting Specialty Eating Disorder Clinical Treatment With a Smartphone Application: A Pilot RCT
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
研究概览
简要总结
Cognitive behavioural therapy (CBT) is the most empirically supported and researched treatment for eating disorders. A central component of CBT for eating disorders is self-monitoring which involves patients keeping a paper food record of their meals and associated thoughts, feelings, and behaviours and receiving feedback from a clinician to help target dysfunctional cognitions and behaviours. Given the issues associated with paper journals such as non-compliance, feelings of shame when used in public, and delayed feedback, researchers have developed an evidence-based smartphone application (Recovery Record) for eating disorder self-monitoring that links patients with their clinicians and offers additional features designed to enhance treatment.
The current pilot randomised controlled trial (RCT) seeks to evaluate this smartphone application in a clinical setting alongside standard eating disorder outpatient treatment. Patients will be recruited from the Nova Scotia Health Authority Eating Disorder Outpatient Program and randomised to receive either standard treatment or standard treatment with the app (instead of the paper food record). The efficacy and acceptability of both treatments will be assessed and compared. Coping skill use and self-efficacy among patients will also be examined given the skill building focus of treatment and in-app capabilities to deliver real-time coping skill suggestions to patients.
This pilot study will be the first to examine the efficacy and acceptability of a smartphone application in eating disorder clinical treatment and if successful, should provide preliminary support for the use of smartphone applications over traditional paper food journals as a self-monitoring tool for augmenting specialty eating disorder clinical treatment.
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
- None
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
- •Patients with an eating disorder (anorexia nervosa, bulimia nervosa, or eating disorder not otherwise specified) according to DSM-V criteria (American Psychiatric Association, 2013) as determined through a standard clinical interview by either a team psychiatrist or clinical psychologist, and validated with a self-report diagnostic measure.
- •Patients with an Apple or Android smartphone (a mobile phone with access to third-party applications and advanced features) with an active data plan or frequent (e.g., daily) Wi-Fi access.
- •Patients 17 years or older.
- •Signed consent from patient.
排除标准
- •Patient has insufficient knowledge of English.
结局指标
主要结局
Change in eating disorder severity as assessed by the Eating Disorder Examination Questionnaire (EDE-Q)
时间窗: Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up
A self-report scale that assesses the severity of 4 areas of eating disorder pathology: Eating Concern, Weight Concern, Dietary Restraint, and Shape Concern. Overall eating disorder severity is also assessed.
次要结局
- Change in coping self-efficacy as assessed by the Coping Self-Efficacy Scale (CSES)(Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up)
- Change in coping skill use as assessed by the Dialectical Behavior Therapy Ways of Coping Checklist (DBT-WCCL)(Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up)
- Treatment acceptability as assessed by the Outpatient Client Experience Survey(Post-treatment (up to 8 months after pre-treatment))
- Treatment acceptability as assessed by a treatment-specific questionnaire(Post-treatment (up to 8 months after pre-treatment))
- Change in coping skill use as assessed by the Cognitive Behavioral Therapy Skills Questionnaire (CBTSQ)(Pre-treatment, 2 months, post-treatment (up to 8 months after pre-treatment), 3-month follow-up)
- Dropout rate(Post-treatment (up to 8 months after pre-treatment))
研究者
Aaron Keshen
Psychiatrist
Nova Scotia Health Authority