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NCT Number: NCT06256380

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

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.

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Key information

Conditions

Feeding and Eating Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive

Age range

12 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital, Bergen, Norway

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Cognitive-behavior therapy for adolescents with an eating disorder

Behavioral

Psychotherapy

Family-based therapy for adolescents with an eating disorder

Behavioral

Psychotherapy

Primary outcomes

  1. 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

  1. Change in eating disorder psychopathology

    Time frame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment.

    Change in global and subscale scores on a well-validated self-report questionnaire of eating disorder attitudes and behavior, the Eating Disorder Examination-Questionnaire. Possible scores range from 0-6 where higher scores indicate worse symptoms.

  2. 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).

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

    Weight gain in kilogram. Higher weight gain means better outcome.

  3. Change in depression

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

    Change in global score on a well-validated self-report questionnaire of depression, the Beck Depression Inventory II. Possible scores range from 0 to 63 where higher scores mean worse symptoms.

  4. Change in anxiety

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

    Change in global score on a well-validated self-report questionnaire of anxiety, the Beck Anxiety Inventory. Possible scores range from 0 to 63 where higher scores mean worse symptoms.

  5. Change in quality of life

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

    Change in global score on a well-validated self-report measure of quality of life, Health-Related Quality of Life Index (KIDDIESCREEN 10). Possible scores range from 10 to 50 where higher scores mean better quality of life.

  6. Change in impairment due to eating difficulties

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

    Change in global score on well validated self report measure of eating disorders-specific quality of life, the Clinical Impairment assessment. Possible scores range from 0 (no impairment) to 48 (highest level of impairment).

  7. Change in self-esteem

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

    Change in global score on a well validated self-report measure of self-esteem, the Rosenberg Self-Esteem Scale questionnaire. Scores range from 10 to 40, where higher scores mean better self-esteem.

Other outcomes

  1. Changes in family function

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

    Change in parent ratings of family functioning measured by the subscale score on a well validated self-report questionnaire- the McMaster Family Assessment Device, General Functioning subscale. Scores on this subscale range from 12 to 48, where higher scores means worse level of family function.

  2. Changes caregiving experience and psychological symptoms

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

    Change in parent ratings on the impact of eating disorder symptoms on caregiving experiences measured by a well validated, self-report measure -the Eating Disorders Symptom Impact Scale. Scores range from 0 to 96, where higher scores mean worse impact of eating disorder symptoms.

  3. Changes caregiving mental health

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

    Change in parent ratings on the mental health symptoms by a well validated, self-report measure -the Hopkins symptoms checklist 25 items. Scores range from 1 to 4 where higher scores mean worse mental health symptoms.

  4. Direct and indirect costs of health care use for patients and parents/caregivers

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

    Register data from the Norwegian Control and Payment of Health Reimbursements Database (KUHR), the Norwegian Patient Registry (NPR), and Social Security Database.

Study contacts

Contact information is provided by the study sponsor or research team.

Ingrid Funderud, PhD

CONTACT

[email protected]

+4723016230

Øyvind Rø, MD

CONTACT

[email protected]

+4723016230

Sponsors and collaborators

Lead sponsor

Oslo University Hospital

Other

Collaborators

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

Registry information

Official study title

Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial

Acronym: CogFam

Important dates

Study start
2024
Primary completion
2028
Study completion
2033
First posted
Feb 13, 2024
Registry last updated
Dec 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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