Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| South-Eastern Norway Regional Health Authority | OTHER |
| University of Oslo | OTHER |
| Villa Garda Hospital | OTHER |
| University of California, San Francisco |
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Enhanced Cognitive-behavior therapy for adolescents with an eating disorder | Behavioral | Psychotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eating disorder psychopathology | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in family function | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ingrid Funderud, PhD | Contact | +4723016230 | ifunderu@ous-hf.no | |
| Øyvind Rø, MD | Contact | +4723016230 | oyvind.ro@ous-hf.no |
| Name | Affiliation | Role |
|---|---|---|
| Øyvind Rø, MD | Oslo University Hospital | Principal Investigator |
| Ingrid Funderud, PhD | Oslo University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Haukeland University Hospital | Recruiting | Bergen | 5009 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| OTHER |
| St. Olavs Hospital | OTHER |
| University Hospital of North Norway | OTHER |
| Haukeland University Hospital | OTHER |
| Vestre Viken Hospital Trust | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
| Family-based therapy for adolescents with an eating disorder | Behavioral | Psychotherapy |
|
| 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). | Weight gain in kilogram. Higher weight gain means better outcome. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Change in depression | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Change in anxiety | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Change in quality of life | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Change in impairment due to eating difficulties | 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). | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Change in self-esteem | 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. | 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 | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Changes caregiving mental health | 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. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Direct and indirect costs of health care use for patients and parents/caregivers | Register data from the Norwegian Control and Payment of Health Reimbursements Database (KUHR), the Norwegian Patient Registry (NPR), and Social Security Database. | Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment |
| Vestre Viken Health Trust | Recruiting | Drammen | 30004 | Norway |
|
| Oslo University Hospital | Recruiting | Oslo | 0424 | Norway |
|
| University Hospital of North Norway | Recruiting | Tromsø | 9019 | Norway |
|
| St. Olav Hospital | Recruiting | Trondheim | 7030 | Norway |
|
| ID | Term |
|---|---|
| D001068 | Feeding and Eating Disorders |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
Not provided
Not provided