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

NCT06256380 | Recruiting

• 1 other identifier: CogFamNorway
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 5

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.

Conditions

Feeding and Eating Disorders

Outcome Measures

Primary Outcomes (1)

• Change in eating disorder psychopathology

  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.

  Baseline, immediately after the intervention.

Secondary Outcomes (7)

• 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 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 anxiety

  Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment

• Change in quality of life

  Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment

Other Outcomes (4)

• Changes in family function

  Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment

• Changes caregiving experience and psychological symptoms

  Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment

• Changes caregiving mental health

  Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment

Study Arms (2)

Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E)

EXPERIMENTAL

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.

Behavioral: Enhanced Cognitive-behavior therapy for adolescents with an eating disorder

Family-based treatment for adolescents with an eating disorder (FBT)

ACTIVE COMPARATOR

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.

Behavioral: Family-based therapy for adolescents with an eating disorder

Interventions

Enhanced Cognitive-behavior therapy for adolescents with an eating disorder BEHAVIORAL

Psychotherapy

Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E)

Family-based therapy for adolescents with an eating disorder BEHAVIORAL

Psychotherapy

Family-based treatment for adolescents with an eating disorder (FBT)

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Oslo University Hospital: lead
• South-Eastern Norway Regional Health Authority: collaborator
• University of Oslo: collaborator
• Villa Garda Hospital: collaborator
• University of California, San Francisco: collaborator
• St. Olavs Hospital: collaborator
• University Hospital of North Norway: collaborator
• Haukeland University Hospital: collaborator
• Vestre Viken Hospital Trust: collaborator

Study Sites (5)

Haukeland University Hospital

Bergen, 5009, Norway

RECRUITING

Vestre Viken Health Trust

Drammen, 30004, Norway

RECRUITING

Oslo University Hospital

Oslo, 0424, Norway

RECRUITING

University Hospital of North Norway

Tromsø, 9019, Norway

RECRUITING

St. Olav Hospital

Trondheim, 7030, Norway

RECRUITING

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Øyvind Rø, MD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

• Ingrid Funderud, PhD

  Oslo University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ingrid Funderud, PhD

CONTACT

+4723016230; ifunderu@ous-hf.no

Øyvind Rø, MD

CONTACT

+4723016230; oyvind.ro@ous-hf.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research director

Study Record Dates

• First Submitted: December 21, 2023
• First Posted: February 13, 2024
• Study Start: March 7, 2024
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2033
• Last Updated: December 24, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

NO (5)