Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder

Not Applicable

Recruiting

• Conditions: Feeding and Eating Disorders

• Registration Number: NCT06256380
• Lead Sponsor: Oslo University Hospital

Brief Summary

The goal of this randomized controlled clinical trial is to compare the efficacy of outpatient family-based treatment versus enhanced cognitive behavior therapy for children and adolescents with eating disorders.

The main aim is to determine if enhanced cognitive behavior therapy has a similar efficacy as family-based treatment among children and adolescents with eating disorders receiving treatment in an outpatient setting. The main outcome is improvement in eating disorders psychopathology at the end of treatment.

Detailed Description

Eating disorders (EDs) are severe mental illnesses, associated with high morbidity, increased mortality, and reduced quality of life. Despite treatment advancements, remission rates are modest. Even in specialized treatment settings offering evidence-based treatments such as family-based treatment (FBT), remission rates are about 50%. There is emerging evidence for the effectiveness of enhanced cognitive behavior therapy (CBT-E) for adolescents with EDs. However, no randomized controlled trial (RCT) has yet compared these two treatments.

The current study will compare FBT, which has proven efficacious and is currently recommended for adolescents with EDs, and the newer treatment approach of CBT-E in a large, national RCT. Young patients with all EDs (12-18 years of age) undergoing outpatient treatment from eight different clinics in Norway will be invited to participate in the study.

Primary aim:

This study is a randomized controlled trial comparing the efficacy of outpatient family-based treatment versus enhanced cognitive behavior therapy for children and adolescents with eating disorders. The main outcome is improvement in eating disorders psychopathology at the end of treatment.

Secondary aims:

To compare weight gain for underweight patients, changes in comorbid psychopathology including depression, self-esteem, family functioning, and quality of life at 6-and 12-months follow-up.

Potential moderators of outcome will be explored. Treatment satisfaction and experiences of the two different treatments will be investigated from the perspective of patients, parents, and clinicians. Data from the Norwegian Control and Payment of Health Reimbursements Database (KUHR), the Norwegian Patient Registry (NPR), and Social Security Database will be obtained to compare the direct and indirect costs of health care utilization for the two treatments.

Study Timeline

• Study First Submitted: 2023-12-21
• Study First Submitted QC: 2024-02-04
• Study First Posted: 2024-02-13
• Study Start: 2024-03-07
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-11
• Last Update Posted: 2025-04-16
• Primary Completion: 2028-12-31
• Study Completion: 2033-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

1. Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed eating disorder
2. Medically stable for outpatient treatment.
3. Living with at least one of their parents
4. At least one of their parents could be actively involved in the treatment
5. Sufficient knowledge in reading, understanding and speaking Norwegian

Exclusion Criteria

1. Avoidant restrictive food intake disorders
2. A co-morbid medical condition or disorder known to influence eating or weight, or influence the possibilities to take part in treatment
3. Psychotic disorders
4. Acute suicidality
5. Substance abuse and/or substance dependence
6. Serious traumatic events in the family making treatment following FBT or CBT-E manual not recommended
7. Unstable psychotropic medication last 6 weeks

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in eating disorder psychopathology	Baseline, immediately after the intervention.	Change in global scores on a well-validated semi-structured interview of eating disorder attitudes and behavior, the Eating Disorder Examination - Interview. Possible scores range from 0-6 where higher scores indicate worse symptoms.

Secondary Outcome Measures

Name	Time	Method
Change in quality of life	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment	Change in global score on a well-validated self-report measure of quality of life, Health-Related Quality of Life Index (KIDDIESCREEN 10). Possible scores range from 10 to 50 where higher scores mean better quality of life.
Change in eating disorder psychopathology	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment.	Change in global and subscale scores on a well-validated self-report questionnaire of eating disorder attitudes and behavior, the Eating Disorder Examination-Questionnaire. Possible scores range from 0-6 where higher scores indicate worse symptoms.
Change in self-esteem	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment	Change in global score on a well validated self-report measure of self-esteem, the Rosenberg Self-Esteem Scale questionnaire. Scores range from 10 to 40, where higher scores mean better self-esteem.
Change in weight (kg) for underweight participants (defined as those participants who are below 18,5 Body Mass Index (BMI) (kg/m2) at baseline or corresponding BMI to age and gender).	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment	Weight gain in kilogram. Higher weight gain means better outcome.
Change in depression	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment	Change in global score on a well-validated self-report questionnaire of depression, the Beck Depression Inventory II. Possible scores range from 0 to 63 where higher scores mean worse symptoms.
Change in impairment due to eating difficulties	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment	Change in global score on well validated self report measure of eating disorders-specific quality of life, the Clinical Impairment assessment. Possible scores range from 0 (no impairment) to 48 (highest level of impairment).
Change in anxiety	Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment	Change in global score on a well-validated self-report questionnaire of anxiety, the Beck Anxiety Inventory. Possible scores range from 0 to 63 where higher scores mean worse symptoms.

Trial Locations

Locations (5)

Vestre Viken Health Trust; 🇳🇴 Drammen, Norway

Haukeland University Hospital; 🇳🇴 Bergen, Norway

Oslo University Hospital; 🇳🇴 Oslo, Norway

University Hospital of North Norway; 🇳🇴 Tromsø, Norway

St. Olav Hospital; 🇳🇴 Trondheim, Norway