Evaluation of a Personalised Digital Treatment for Adolescents With Eating Disorders - An Open Feasibility Trial in Routine Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Module evaluations
研究概览
简要总结
The goal of this feasibility study is to evaluate the feasibility and preliminary clinical outcomes of a personalized digital treatment for adolescents with eating disorders. The main objectives are to:
i) Evaluate whether a personalized digital treatment for adolescents with eating disorders are feasible in a child and adolescent psychiatric outpatient clinic.
ii) Evaluate who benefits from a personalized digital treatment for adolescents with eating disorders (what works for whom?) iii) Evaluate the cost-benefit of a personalized digital treatment for adolescents with eating disorders.
Participants will be enrolled in a 10-week digital treatment including weekly therapist contact. They will be asked to complete self-report questionnaires at pre-, during, post- and 3- and 6-months follow-up.
详细描述
Eating disorders are associated with high levels of distress, significant somatic problems, and high mortality. The difficulties have significant consequences for the individual, family members, and society at large. Early treatment leads to better prognosis, but the identification and treatment of eating disorders are challenging within the healthcare system. The effect of digital treatments for patients with eating disorders appears promising.
In this study, we will investigate the feasibility and preliminary effects of therapist-guided digital treatment for youth with eating disorders using qualitative and quantitative methods. The project uses the Person-based approach (PBA) as methodological framework, which is an evidence-based method for developing user-centered and effective behavior change interventions.
The study wants the examine the intervention within six feasibility domains that includes the following research questions:
Feasibility domain 1. Sample distribution of general psychopathology of eating disorder symptoms:
A. Will a reasonable wide spectrum of individuals with different forms of eating disorders show interest and be eligible? B. Will 60 adolescents be eligible over the course of one year? C. What characterizes the group that participate (predictor)?
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 15 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A. Diagnosed with F50.1 Atypical anorexia nervosa, F50.3 Atypical bulimia nervosa, F50.8 Other eating disorders, F50.9 Eating disorder, unspecified
- •B. Age between 15 and 18 years.
- •C. Stable dose of medication for a co-morbid psychiatric treatment for six weeks and who continue to meet study entry criteria.
- •D. Internet access.
- •E. Speaks and write Norwegian.
排除标准
- •A. Diagnosed with F50.0 Anorexia nervosa or F50.2 Bulimia nervosa
- •B. Disorders of psychological development (F80-F89).
- •C. Patients with avoidant restrictive food intake disorders (F50.82)
- •D. Participants with a co-morbid medical condition or disorder known to influence eating or weight (i.e., pregnancy, cancer), psychotic disorders, acute suicidality, or substance abuse and/or substance dependence and severe depressive episode.
- •E. Receiving inpatient- or face to face psychological treatment.
结局指标
主要结局
Module evaluations
时间窗: Up to 10 weeks
After each treatment module the participants will be asked to evaluate the module which will be used to assess acceptability of the intervention. With a 6-item self-report questionnaire assessed on a 5-point Likert scale ranging from "completely disagree" to "completely agree".
Eating disorder symptoms
时间窗: Up to 6-months follow-up
Eating Disorder Examination-Questionnaire Short (EDE-QS) is a 12 item self-report questionnaire that with a 4-point response scale assess eating disorder symptom severity over the preceding 7 days. It has demonstrated good psychometric properties at initial testing.
The KIDSCREEN (KIDSCREEN-10)
时间窗: Up to 6 months follow-up
The KIDSCREEN (KIDSCREEN-10) will be used to assess quality of life. The items are rated on 5-point Likert scale that indicates the frequency or intensity of a behavior or emotion.
The Credibility and Expectancy Scale (CEQ-1)
时间窗: One week
CEQ-1 will be used after participants have completed the first module of the treatment. CEQ measures perceived treatments credibility. We will use 1-item "How confident would you be in recommending this treatment to a friend who experiences similar problems?" The item is rated on a scale from 0 to 10, where higher score indicates better treatment credibility.
Adherence
时间窗: Up to 10 weeks
Adherence (dropout rates and completion of modules) will be used to assess the acceptability of the intervention. The total number of logged on sessions during the intervention period will be collected, and the average length of sessions. Days in treatment will be calculated based on the dates between the first login, and the completion of the last module.
Client Satisfaction Questionnaire (CSQ-3)
时间窗: 10 weeks
Intervention satisfaction will be measured at post-treatment, using the 3-item Client Satisfaction Questionnaire (CSQ-3) CSQ-3 are items 3, 7, \& 8 from the CSQ-8. Each item on the CSQ-3 is scored from 1 to 4, where a higher score indicate higher satisfaction.
Recruitment
时间窗: 1 year
Number of participants of participants recruited and inclusion rate will be used to assess the acceptability.
The Clinical Impairment Assessment Questionnaire (CIA)
时间窗: Up to 6-months follow-up
We will use the The Clinical Impairment Assessment Questionnaire (CIA) to assess quality of life. CIA assess the severity of psychosocial impairment due to eating disorder features. It is a 16-item self-report questionnaire that cover impairment in domains of life that are typically affected by eating disorder psychopathology: mode and self-perception, cognitive functioning, interpersonal functioning, and work performance.
次要结局
- The Patient Health Questionnaire (PHQ-2)(Up to 6-months follow-up)
- EuroQoL 5D-5L (EQ-5D-5L)(Up to 6-months follow-up)
- Generalized Anxiety Disorder scale (GAD-2)(Up to 6-months follow-up)
- School attendance(Up to 6-months follow-up)
- Tme with friends(Up to 6-months follow-up)
- Difficulties with Emotion Regulation Scale (DERS-18)(Up to 6-months follow-up)