Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Feeding and Eating Disorders
- Sponsor
- Oslo University Hospital
- Enrollment
- 200
- Locations
- 5
- Primary Endpoint
- Change in eating disorder psychopathology
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
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.
Because of insufficient recruitment, the study design was modified on December 1st, 2025, to a partially randomized preference design.
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. Because of insufficient recruitment, the study design was modified on December 1st, 2025, to a partially randomized preference design. 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.
Investigators
Øyvind Rø MD
Research director
Oslo University Hospital
Eligibility Criteria
Inclusion Criteria
- •Diagnostic and Statistical Manual of Mental Disorders (DSM-5) diagnosed eating disorder
- •Medically stable for outpatient treatment.
- •Living with at least one of their parents
- •At least one of their parents could be actively involved in the treatment
- •Sufficient knowledge in reading, understanding and speaking Norwegian
Exclusion Criteria
- •Avoidant restrictive food intake disorders
- •A co-morbid medical condition or disorder known to influence eating or weight, or influence the possibilities to take part in treatment
- •Psychotic disorders
- •Acute suicidality
- •Substance abuse and/or substance dependence
- •Serious traumatic events in the family making treatment following FBT or CBT-E manual not recommended
- •Unstable psychotropic medication last 6 weeks
Outcomes
Primary Outcomes
Change in eating disorder psychopathology
Time Frame: 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 Outcomes
- 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 eating disorder psychopathology(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment.)
- 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 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)
- Change in depression(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)
- 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 anxiety(Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment)