Ignite Creation Date:
2024-05-06 @ 8:06 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06256380
Status:
RECRUITING
Last Update Posted:
2024-03-21
First Post:
2023-12-21
Brief Title:
Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder
Sponsor:
Oslo University Hospital
Organization:
Oslo University Hospital
Study Overview
Official Title:
Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder a Non-inferiority Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CogFam
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
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None