Comparing two therapies for adolescents with eating disorders
Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial
This study is testing which treatment, enhanced cognitive behavior therapy or family-based therapy, works better for teenagers with eating disorders to help them feel better and improve their lives.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 12 Years to 18 Years |
| Sex | All |
| Sponsor | Oslo University Hospital Academic / other |
| Locations | 5 sites (Bergen and 4 other locations) |
| Trial ID | NCT06256380 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the effectiveness of enhanced cognitive behavior therapy (CBT-E) and family-based treatment (FBT) for adolescents aged 12-18 with eating disorders. The study will involve a randomized controlled design, enrolling participants from eight outpatient clinics in Norway. The primary outcome will focus on improvements in eating disorder psychopathology at the end of treatment, while secondary outcomes will assess weight gain, comorbid psychopathology, and overall quality of life at follow-up intervals.
Who should consider this trial
Good fit: Ideal candidates are adolescents aged 12-18 diagnosed with an eating disorder who are medically stable and living with at least one parent who can participate in treatment.
Not a fit: Patients with avoidant restrictive food intake disorders, psychotic disorders, or acute suicidality may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence for more effective treatment options for adolescents with eating disorders.
How similar studies have performed: While enhanced cognitive behavior therapy has shown promise, this is the first randomized controlled trial comparing it directly with family-based treatment for adolescents with eating disorders.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Bergen and 4 other locations
- Haukeland University Hospital — Bergen, Norway (Recruiting)
- Vestre Viken Health Trust — Drammen, Norway (Recruiting)
- Oslo University Hospital — Oslo, Norway (Recruiting)
- University Hospital of North Norway — Tromsø, Norway (Recruiting)
- St. Olav Hospital — Trondheim, Norway (Recruiting)
Study contacts
- Principal investigator: Øyvind Rø, MD — Oslo University Hospital
- Study coordinator: Ingrid Funderud, PhD
- Email: ifunderu@ous-hf.no
- Phone: +4723016230
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.