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

Feeding and Eating Disorders Clinical Trial

— CogFam  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06256380
• Other study ID #: CogFamNorway
• Status: Recruiting
• Phase: N/A
• Start date: March 7, 2024
• Est. completion date: December 31, 2033

Study information

• Verified date: March 2024
• Source: Oslo University Hospital
• Contact: Anne Louise Wennerberg, Master
• Phone: +4723016230
• Email: UXWEAC[@]ous-hf.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: December 31, 2033
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Feeding and Eating Disorders

Intervention

Behavioral:
• Enhanced Cognitive-behavior therapy for adolescents with an eating disorder
Psychotherapy
• Family-based therapy for adolescents with an eating disorder
Psychotherapy

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen
Norway	Oslo University Hospital	Oslo
Norway	University Hospital of North Norway	Tromsø
Norway	St. Olav Hospital	Trondheim

Sponsors (8)

Lead Sponsor	Collaborator
Oslo University Hospital	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, Villa Garda Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Primary	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.
Secondary	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.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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