i-TREAT: An Internet-based Guided Self-help Program for Adolescents and Adults With Other Specified Feeding or Eating Disorders - A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 126
- 试验地点
- 2
- 主要终点
- Eating Disorder Examination Questionnaire (EDE-Q)
研究概览
简要总结
This clinical study aims to compare the efficacy of an internet-based therapist-guided self-help intervention (named i-TREAT) in reducing eating disorder symptoms in Danish adolescents and adults with Other Specified Feeding or Eating Disorders (OSFED). The study is a randomized controlled trial, comparing the intervention group, receiving i-TREAT, with an active waitlist-control group, receiving online mindfulness material. The investigators hypothesize the intervention group to be superior to the waitlist-control group in terms of 1) reducing eating disorder symptoms and 2) increasing quality of life. The internet-based intervention (i-TREAT) consists of 12 online treatment sessions. It is mainly based on Cognitive Behavior Therapy while inspired by Acceptance and Commitment Therapy. Participants are instructed to complete session-related tasks and receive written feedback from their therapist throughout the treatment.
Furthermore, the intervention is also supported by text, illustrations, videos, and a chat function, allowing asynchronous text messaging with the therapist. The treatment courses are expected to run for up to 12 weeks. Participants completing the 12-week waitlist are subsequently offered the i-TREAT intervention. The investigators expect to include 63 participants in each group, who will be recruited through 1) self-referral on the project's website and 2) referral from mental health institutions and doctors.
详细描述
- Intervention (i-TREAT)
The online treatment program (i-TREAT) consists of 12 sessions developed in cooperation with clinical psychologists and technical staff and is hosted on the digital platform MindDistrict that can be accessed by computer or mobile app. The text-based treatment content is supported by videos and illustrations, which is recommended by Andersson. The treatment is based on cognitive behavioral therapy that has been widely used in other international eating disorder treatments. Thus, the treatment sessions include psychoeducation about eating disorders, treatment-related tasks, such as observation of their behavior in real time and identifying perpetuating and maintaining factors, establishing coping strategies and behavioral changes, and receiving written support from a clinician.
Patients will be guided through the treatment by a clinician specialized in eating disorders. Clinicians are providing written feedback for the patient after completion of each session. The feedback must be sent no later than seven days after session completion. Additionally, patients can communicate with their therapist though an asynchronous chat function, supported by a feature enabling the patients to invite relatives to the chat as well. This feature is vital, as adolescents will be required to involve their parents in the treatment process. However, unlike family therapy, which actively involves the parents to take responsibility for the treatment and control of their child's eating, Enhanced Cognitive Behavioral Therapy (CBT-E) for adolescents with eating disorders gives more autonomy to the patient and changes the parents' role to being more supportive rather than directive. This is one of the features of internet-based Cognitive Behavioral Therapy (iCBT), which makes it suitable for younger patients, as it fits their needs and concerns about control, while promoting independence and autonomy. The internet-based treatment format further strengthens these benefits. In the asynchronous chat function, patients can discuss with the therapist and parents how the parents may assist the patient in establishing changes while informing the parents about the treatment and child's progress. Furthermore, patients may address questions or comments about treatment content or tasks, personal experiences, motivational issues etc. It is also possible to permanently save all content and tasks on their hardware.
The treatment program is both available on web-browser and app. 2. Methods
2.1. Design
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 15 to 17 years, or age ≥ 18 years.
- •Fulfilment of the diagnostic criteria for Other Specified Feeding or Eating Disorders according to DSM-V and ICD-
- •Comprehension of the Danish language.
- •Consent from at least one parent for participants between 15 to 17 years.
- •Access to the Danish secure mail system E-boks.
排除标准
- •Body Mass Index (BMI) ≤ 17,
- •Lack of access to technological device (computer and tablet/iphone/android).
- •Concurrent participation in other psychotherapeutic treatment.
- •Concurrent diagnosis of severe depression, severe anxiety, or substance dependence disorder.
- •Previously diagnosed with psychosis or Autism Spectrum Disorder.
- •If on medication, medication must be stable for six months prior to, as well as during, the study participation (i.e., no changes in type of medication or dosage).
结局指标
主要结局
Eating Disorder Examination Questionnaire (EDE-Q)
时间窗: Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months)
The Eating Disorder Examination Questionnaire (EDE-Q) is a self-report questionnaire assessing the severity and type of eating disorder symptoms and psychopathology during the preceding 28 days. The current version is designed to generate Diagnostic and Statistical Manual of Mental Disorders (DSM-5) compatible eating disorder diagnoses. Finally, the EDE-Q has an excellent internal consistency reliability (Cronbach's α = .95) and is considered the gold standard for measuring eating disorder psychopathology.
次要结局
- EuroQol - 5 Dimension - 5 Level (EQ-5D-5L)(Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months))
- SCOFF Questionnaire(Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months))
- Major Depression Inventory (MDI)(Baseline (Day 0), mid-treatment (up to six weeks), post-treatment (up to 12 weeks), and follow-up (three months))
研究者
Eik Runge
Principal investigator
Region of Southern Denmark