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Eating DisordersNCT06306586

A Digital Treatment for Adolescents With Eating Disorders

A study testing Digital Treatment for Adolescents With Eating Disorders in people with Eating Disorders, run by Haukeland University Hospital at 3 sites in Norway.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 15 to 18 years
Conditions the study is for
Eating Disorders
What is being tested?
Digital Treatment for Adolescents With Eating Disorders
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
3 sitesNorway
Study dates
11 Mar 2024to 1 Jan 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Diagnosed with F50.1 Atypical anorexia nervosa, F50.3 Atypical bulimia nervosa, F50.8 Other eating disorders, F50.9 Eating disorder, unspecified
  • Age between 15 and 18 years.
  • Stable dose of medication for a co-morbid psychiatric treatment for six weeks and who continue to meet study entry criteria.
  • Internet access.
  • Speaks and write Norwegian.

Who cannot join

  • Diagnosed with F50.0 Anorexia nervosa or F50.2 Bulimia nervosa
  • Disorders of psychological development (F80-F89).
  • Patients with avoidant restrictive food intake disorders (F50.82)
  • 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.
  • Receiving inpatient- or face to face psychological treatment.

Trial locations and contacts

3 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Norway3 sites, 1 recruiting
  • Haukeland University Hospital

    Bergen

    Recruiting
  • Bømlo Kommune

    Bømlo, Vestland

    Withdrawn
  • Helse Fonna

    Haugesund

    Completed

Other trials in Norway

About this study

Official title: Evaluation of a Personalised Digital Treatment for Adolescents With Eating Disorders - An Open Feasibility Trial in Routine Care

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:

  1. 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.

Read the detailed description

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:

  1. 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)?

Feasibility domain 2. Adherence to the treatment protocol:

  1. Do 50% of the adolescents complete the entire intervention? B, What characterizes those who carry out the treatment (predictor)? C. What characterizes those who drop out (predictor)?

Feasibility domain 3. Treatment credibility:

  1. Will 70% of the participants rate the treatment as acceptable/recommend it to a friend?

Feasibility domain 4. Treatment acceptability:

  1. What are the adolescents' experiences of a personalised digital treatment targeting eating disorders?

Feasibility domain 5. Treatment use and utility:

  1. Will a moderate within-group effect, around d=0.50, be seen on general psychopathology of eating disorder? B. Will more than 40% of the sample obtain a significant reliable change on primary outcome? C. Will less than 10% of the sample experience negative effects and/or deterioration defined as a negative significant reliable change?

Feasibility domain 6. Treatment cost-effectiveness:

  1. What is the cost-effectiveness of a personalized digital treatment for for adolescents with eating disorders in routine care?

Youth between the ages of 16-18 with an eating disorder will be invited to participate in this intervention study. The participants will be recruited via child and youth psychiatric outpatient clinics and social and media. Eligible participants get access to an online information consent form which is signed digitally using the Norwegian electronic identification system BankID.

Data will be collected using self-report questionnaires administrated online at pre-, during, post- and 3- and 6-months follow-up. All measures are previously validated and have been used in eating disorder adolescent populations. Based on the literature potential predictors are included in the study protocol. The pre-treatment symptoms variables are associated with external clinical features, which maintain an eating disorder. The predictor variables will be collected pre-treatment.

We will conduct semi-structured phone interviews to explore the patients' in-depth experience of the digital treatment. The interviews of approximately 16 adolescents will be conducted 2-4 weeks after finishing the treatment. We will strive to have two groups, one with participants that finished the treatment, and one with dropouts.

Being tested
Digital Treatment for Adolescents With Eating Disorders
Keywords
Digital interventions, eating disorders, adolescents
Medical subject headings
Feeding and Eating Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Digital Treatment for Adolescents With Eating DisordersBehavioural

    Also called e-balanse

    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.
Study groups in NCT06306586
Study groupRoleWhat they receive
Digital Treatment for Adolescents With Eating DisordersExperimentalThe digital treatment is guided by a therapist and comprises 8 modules, running over a span of 10 weeks.
Receives: Behavioral: Digital Treatment for Adolescents With Eating Disorders

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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.

    Measured: 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".

    Measured: 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.

    Measured: 10 weeks

  5. Recruitment

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

    Measured: 1 year

  6. 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.

    Measured: Up to 6-months follow-up

  7. 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.

    Measured: Up to 6-months follow-up

  8. 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.

    Measured: Up to 6 months follow-up

Secondary outcomes (6)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Up to 6-months follow-up

  5. Difficulties with Emotion Regulation Scale (DERS-18)

    Difficulties with Emotion Regulation Scale (DERS-18) are used to assess used to facilitate understanding of how emotion dysregulation is associated with psychiatric symptoms, other emotion-related constructs, and treatment progress. Responses are rated one a scale from 1 to 5, ranging from never to almost always, where a higher score indicates higher severity.

    Measured: Up to 6-months follow-up

  6. EuroQoL 5D-5L (EQ-5D-5L)

    EuroQoL 5D-5L (EQ-5D-5L) measures health-related quality of life and provide data for calculation of Quality Adjusted Life Years (QALY), to be used in the economic evaluation. The questionnaire covers five dimensions of health (mobility, self-care, usual activities, pain/discomfort and anxiety/depression), identify the health states and together with preference scores provides a single index score in order to calculate QALYs.

    Measured: Up to 6-months follow-up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2024
  2. Study start11 Mar 2024
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Jan 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
60 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06306586
Sponsor's protocol ID
639031
Status last verified
Mar 2025
First submitted
28 Feb 2024
Last updated
22 Dec 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Holgersen G, Nordby ES, Espeset EMS, Nordgreen T. The acceptability, adherence, and preliminary effectiveness of a digital treatment for adolescents with subthreshold eating disorders. Findings from an open feasibility trial in routine clinical care. J Eat Disord. 2026 Apr 9;14(1):115. doi: 10.1186/s40337-026-01596-9.

    PubMed 41957670

Questions about this trial

What is this clinical trial studying?

A study testing Digital Treatment for Adolescents With Eating Disorders in people with Eating Disorders, run by Haukeland University Hospital at 3 sites in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Emilie Nordby, MA (55975000 ext. +47, emilie.sektnan.nordby@helse-bergen.no), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Credibility and Expectancy Scale (CEQ-1) (time frame: One week). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06306586, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.

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