Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder
- Conditions
- Feeding and Eating Disorders
- Interventions
- Behavioral: Enhanced Cognitive-behavior therapy for adolescents with an eating disorderBehavioral: Family-based therapy for adolescents with an eating disorder
- Registration Number
- NCT06256380
- Lead Sponsor
- Oslo University Hospital
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E) Enhanced Cognitive-behavior therapy for adolescents with an eating disorder 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) Family-based therapy for adolescents with an eating disorder 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.
- Primary Outcome Measures
Name Time Method Change in eating disorder psychopathology 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 Outcome Measures
Name Time Method Change in quality of life 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.
Change in eating disorder psychopathology 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.
Change in self-esteem 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.
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). 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.
Change in depression 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.
Change in impairment due to eating difficulties 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).
Change in anxiety 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.
Trial Locations
- Locations (5)
Vestre Viken Health Trust
🇳🇴Drammen, Norway
Haukeland University Hospital
🇳🇴Bergen, Norway
Oslo University Hospital
🇳🇴Oslo, Norway
University Hospital of North Norway
🇳🇴Tromsø, Norway
St. Olav Hospital
🇳🇴Trondheim, Norway