Clinical trial NCT06256380: Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder
Official title: Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Feeding and Eating Disorders
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
Collaborators: name: South-Eastern Norway Regional Health Authority
name: University of Oslo
name: Villa Garda Hospital
name: University of California, San Francisco
name: St. Olavs Hospital
name: University Hospital of North Norway
name: Haukeland University Hospital
name: Vestre Viken Hospital Trust
First posted: 2024-02-13
Enrollment: 200
Sex: ALL
Minimum age (years): 12
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in eating disorder psychopathology
timeFrame: Baseline, immediately after the intervention.
Secondary outcomes:
measure: Change in eating disorder psychopathology
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment.
measure: 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).
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Change in depression
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Change in anxiety
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Change in quality of life
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Change in impairment due to eating difficulties
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Change in self-esteem
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
Other outcomes:
measure: Changes in family function
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Changes caregiving experience and psychological symptoms
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Changes caregiving mental health
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
measure: Direct and indirect costs of health care use for patients and parents/caregivers
timeFrame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
city: Drammen
country: Norway
facility: Vestre Viken Health Trust
city: Oslo
country: Norway
facility: Oslo University Hospital
city: Tromsø
country: Norway
facility: University Hospital of North Norway
city: Trondheim
country: Norway
facility: St. Olav Hospital
Study officials:
affiliation: Oslo University Hospital
name: Øyvind Rø, MD
role: PRINCIPAL_INVESTIGATOR
References: