A Digital Treatment for Adolescents With Eating Disorders

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age15-18
SponsorHaukeland University Hospital

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 volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Digital Treatment for Adolescents With Eating Disorders

    Behavioral

    The 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

60 Participants
are divided into 1 treatment group
Group A: Digital Treatment for Adolescents With Eating DisordersExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
One week
2

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.

Time frame
Up to 10 weeks
3

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".

Time frame
Up to 10 weeks
4

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.

Time frame
10 weeks

Secondary outcomes

1

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.

Time frame
Up to 6-months follow-up
2

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.

Time frame
Up to 6-months follow-up
3

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.

Time frame
Up to 6-months follow-up
4

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.

Time frame
Up to 6-months follow-up

Other outcomes

1

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.

Time frame
Baseline
2

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).

Time frame
Baseline
3

Qualitative interviews

Qualitative interviews will be conducted following the intervention with 16 participants. We will aim to recruit both treatment completers and treatment dropouts.

Time frame
Up to 4 weeks post-treatment

Sponsors and contacts

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