A Digital Treatment for Adolescents With Eating Disorders

NCT06306586 | Recruiting

• 1 other identifier: 639031
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

Eating Disorders

Keywords

Digital interventions, eating disorders, adolescents

Outcome Measures

Primary Outcomes (8)

• 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.

  One week

• 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.

  Up to 10 weeks

• 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".

  Up to 10 weeks

• 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.

  10 weeks

• Recruitment

  Number of participants of participants recruited and inclusion rate will be used to assess the acceptability.

  1 year

• Eating disorder symptoms

  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.

  Up to 6-months follow-up

• The Clinical Impairment Assessment Questionnaire (CIA)

  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.

  Up to 6-months follow-up

• The KIDSCREEN (KIDSCREEN-10)

  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.

  Up to 6 months follow-up

Secondary Outcomes (6)

• The Patient Health Questionnaire (PHQ-2)

  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

Other Outcomes (3)

• The Rosenberg Self-Esteem Scale (RSES)

  Baseline

• The readiness to change questionnaire (RTCQ-6)

  Baseline

• Qualitative interviews

  Up to 4 weeks post-treatment

Study Arms (1)

Digital Treatment for Adolescents With Eating Disorders

EXPERIMENTAL

The digital treatment is guided by a therapist and comprises 8 modules, running over a span of 10 weeks.

Behavioral: Digital Treatment for Adolescents With Eating Disorders

Interventions

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.

Also known as: e-balanse

Digital Treatment for Adolescents With Eating Disorders

Eligibility Criteria

• Age: 15 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Helse Fonna: collaborator
• Haukeland University Hospital: lead

Study Sites (3)

Bømlo Kommune

Bømlo, Vestland, Norway

WITHDRAWN

Haukeland University Hospital

Bergen, Norway

RECRUITING

Helse Fonna

Haugesund, Norway

COMPLETED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Tine Nordgreen, PhD

  Division of Psychiatry, Haukeland University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Nordby, MA

CONTACT

55975000; emilie.sektnan.nordby@helse-bergen.no

Guri Holgersen, MA

CONTACT

55975000; guri-elise.holgersen@helse-bergen.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2024
• First Posted: March 12, 2024
• Study Start: March 11, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 22, 2025

Record last verified: 2025-03

Locations

NO (3)