Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder
NCT ID: NCT06256380
Last Updated: 2025-12-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
200 participants
INTERVENTIONAL
2024-03-07
2033-12-31
Brief Summary
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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
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E)
CBT-E posits the eating problem as belonging to the individual, and is designed to encourage the adolescent, rather than their parent, to take control of the problem. Parents are not excluded from participating in treatment, but their involvement is limited to helping to create a family environment that allows for recovery. Patients are actively involved in all phases of treatment, including the decision to address weight regain and/or binge eating and purging, with the goal of promoting self-management. A primary goal of CBT-E is to address the patient's eating disorder psychopathology, i.e. patients' concerns about shape, weight, dietary restraint and restriction, and other extreme weight control behaviors. Following manualized CBT-E guidelines, for patients in the lower weight cohort, treatment involves 40 sessions over 9-12 months. For those in the higher weight cohort, treatment involves 20 sessions over the course of 6 months.
Enhanced Cognitive-behavior therapy for adolescents with an eating disorder
Psychotherapy
Family-based treatment for adolescents with an eating disorder (FBT)
FBT for adolescent eating disorders usually includes all members of the adolescent's immediate family. Treatment progresses through three phases, with the first (∼10 sessions) focusing mainly on guiding the parents to support their adolescent toward weight restoration (when appropriate), and disrupting eating disorder behaviors (e.g. binge eating and purging). The second phase (∼5-7 sessions) focuses on assisting the parents to restore food choices to the adolescent, with an emphasis on the developmental stage of the adolescent. Phase 3 is brief (2-3 sessions), focusing on adolescent developmental matters and helping the parents and their offspring navigate these tasks largely in the absence of acute eating disorder symptoms. Twenty treatment sessions are provided over a span of approximately 6 months.
Family-based therapy for adolescents with an eating disorder
Psychotherapy
Interventions
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Enhanced Cognitive-behavior therapy for adolescents with an eating disorder
Psychotherapy
Family-based therapy for adolescents with an eating disorder
Psychotherapy
Eligibility Criteria
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Inclusion Criteria
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
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
12 Years
18 Years
ALL
No
Sponsors
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South-Eastern Norway Regional Health Authority
OTHER
University of Oslo
OTHER
Villa Garda Hospital
OTHER
University of California, San Francisco
OTHER
St. Olavs Hospital
OTHER
University Hospital of North Norway
OTHER
Haukeland University Hospital
OTHER
Vestre Viken Hospital Trust
OTHER
Oslo University Hospital
OTHER
Responsible Party
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Øyvind Rø MD
Research director
Principal Investigators
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Øyvind Rø, MD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Ingrid Funderud, PhD
Role: PRINCIPAL_INVESTIGATOR
Oslo University Hospital
Locations
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Haukeland University Hospital
Bergen, , Norway
Vestre Viken Health Trust
Drammen, , Norway
Oslo University Hospital
Oslo, , Norway
University Hospital of North Norway
Tromsø, , Norway
St. Olav Hospital
Trondheim, , Norway
Countries
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Central Contacts
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Facility Contacts
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Liv Kleve
Role: primary
Hilde Widing, Psychologist
Role: primary
Øyvind Rø
Role: primary
Vibeke Stalsberg
Role: primary
Kari Skulstad Gårvik
Role: primary
Other Identifiers
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CogFamNorway
Identifier Type: -
Identifier Source: org_study_id