About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial design
Single group
Treatments tested in this trial
Digital Treatment for Adolescents With Eating Disorders
BehavioralThe main aim of the digital treatment is to reduce symptoms of eating disorders and increase life-coping skills. The digital treatment aims to help adolescents with eating disorders to: * Gain knowledge about the symptoms of eating disorders and the consequences it has on everyday life. * Be motivated to carry out the treatment. * Gain knowledge of and skills in regulating food and activity in a more balanced way. * Gain knowledge of and skills in managing emotions. * Get tools to develop a better self-esteem. * Gain awareness of the function of the eating disorder. * Gain skills in coping with social challenges. * Get a more realistic image of their bodies and handle information from social media.
Treatment groups
Trial outcomes
Primary outcomes
The Credibility and Expectancy Scale (CEQ-1)
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
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.
Module evaluations
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".
Client Satisfaction Questionnaire (CSQ-3)
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.
Secondary outcomes
The Patient Health Questionnaire (PHQ-2)
The Patient Health Questionnaire (PHQ-2) are used for assessing depression. The PHQ-2, comprising the first 2 items of the PHQ-9, inquiries about the degree to which an individual has experienced depressed mood and anhedonia over the past two weeks. Items are rated on scale from 1 to 4, where a higher rating indicate higher degree of depressed mood.
Generalized Anxiety Disorder scale (GAD-2)
Generalized Anxiety Disorder scale (GAD-2) is used for assessing anxiety disorders. The GAD-2 is a quick version of the seven-item scale that incorporates the first two questions of the GAD-7, which are also critical components of any anxiety disorder.Items are rated on scale from 1 to 4, where a higher rating indicate higher degree of anxiety.
School attendance
In addition, we will collect School attendance (variables: full-time/reduce-time/don't attend school/ don't attend school but have a job) to assess quality of life.
Tme with friends
Time with friends with the categories: daily/weekly/monthly/don't have friends/ don't have time to friends because of my eating disorder, will also be used to assess quality of life.
Other outcomes
The Rosenberg Self-Esteem Scale (RSES)
The Rosenberg Self-Esteem Scale (RSES) to measure self-esteem, a maintaining mechanism. RSES is a widely used 10-item self-report questionnaire. Items are answered on a 4-point scale, ranging from 3 (strongly agree) to 0 (strongly disagree). Scores range from 0 to 40, and higher scores indicate higher global self-worth.
The readiness to change questionnaire (RTCQ-6)
The readiness to change questionnaire (RTCQ-6) is adapted to the study population and digital treatment inspired by the Short Motivation Feedback List (SMFL-8).
Qualitative interviews
Qualitative interviews will be conducted following the intervention with 16 participants. We will aim to recruit both treatment completers and treatment dropouts.
Sponsors and contacts
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Haukeland University Hospital
Lead sponsor
Helse Fonna
Collaborator