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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Psychotherapy
Psychotherapy
Haukeland University Hospital
Bergen, Norway
RECRUITINGVestre Viken Health Trust
Drammen, Norway
RECRUITINGOslo University Hospital
Oslo, Norway
RECRUITINGUniversity Hospital of North Norway
Tromsø, Norway
RECRUITINGSt. Olav Hospital
Trondheim, Norway
RECRUITINGChange 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.
Time frame: Baseline, immediately after the intervention.
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.
Time frame: 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).
Weight gain in kilogram. Higher weight gain means better outcome.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
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