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

University of Oslo (UIO)

Status: Enrolling

Conditions: Feeding and Eating Disorders

Treatments: Behavioral: Enhanced Cognitive-behavior therapy for adolescents with an eating disorder; Behavioral: Family-based therapy for adolescents with an eating disorder

Study type: Interventional

Funder types: Other

Identifiers

NCT06256380

CogFamNorway

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 estimated patients

Sex: All

Ages: 12 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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200 participants in 2 patient groups

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

Experimental group

Description:

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.

Treatment:

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

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

Active Comparator group

Description:

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.

Treatment:

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