Feeding and Eating DisordersCogFamNCT06256380
Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder
A study testing Enhanced Cognitive-behavior therapy for adolescents with an eating disorder and Family-based therapy for adolescents with an eating disorder in people with Feeding and Eating Disorders, run by Oslo University Hospital at 5 sites in Norway.
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. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Feeding and Eating Disorders
- What is being tested?
- Enhanced Cognitive-behavior therapy for adolescents with an eating disorder and Family-based therapy for adolescents with an eating disorder
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 5 sitesNorway
- Study dates
- 7 Mar 2024to 31 Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Norway5 sites, 5 recruiting
- Recruiting
Haukeland University Hospital
Bergen, 5009
Liv Kleve, +0055975000, liv.kleve@helse-bergen.no
- Recruiting
Vestre Viken Health Trust
Drammen, 30004
Hilde Widing, Psychologist, 47 32 80 30 00, hilde.widing@vestreviken.no
- Recruiting
Oslo University Hospital
Oslo, 0424
Øyvind Rø, +47233016230, oyvind.Ro@ous-hf.no
- Recruiting
University Hospital of North Norway
Tromsø, 9019
Vibeke Stalsberg, +4777626000, Vibeke.Stalsberg@unn.no
- Recruiting
St. Olav Hospital
Trondheim, 7030
Kari Skulstad Gårvik, +4772573000, Kari.Skulstad.Gardvik@stolav.no
About this study
Official title: Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial
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.
Read the 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.
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.
- Conditions
- Feeding and Eating Disorders
- Being tested
- Enhanced Cognitive-behavior therapy for adolescents with an eating disorder, Family-based therapy for adolescents with an eating disorder
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced Cognitive-behavior therapy for adolescents with an eating disorderBehavioural
Psychotherapy
Family-based therapy for adolescents with an eating disorderBehavioural
Psychotherapy
| Study group | Role | What they receive |
|---|---|---|
| Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E) | Experimental | 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. Receives: Behavioral: Enhanced Cognitive-behavior therapy for adolescents with an eating disorder |
| Family-based treatment for adolescents with an eating disorder (FBT) | Active comparator | 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. Receives: Behavioral: Family-based therapy for adolescents with an eating disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, immediately after the intervention.
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2024
- Study start7 Mar 2024
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Feeding and Eating DisordersStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University of Oslo, Villa Garda Hospital, University of California, San Francisco, St. Olavs Hospital, University Hospital of North Norway, Haukeland University Hospital, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Øyvind Rø MD, Oslo University Hospital
- Investigators
- Øyvind Rø, MD, Principal investigator, Oslo University HospitalIngrid Funderud, PhD, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06256380
- Sponsor's protocol ID
- CogFamNorway
- Acronym
- CogFam
- Status last verified
- Dec 2025
- First submitted
- 21 Dec 2023
- Last updated
- 24 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Enhanced Cognitive-behavior Therapy and Family-based Treatment for Adolescents With an Eating Disorder: a Non-inferiority Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06256380
- Acronym / sponsor ID
- CogFam / CogFamNorway
- Conditions
- Feeding and Eating Disorders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- South-Eastern Norway Regional Health Authority, University of Oslo, Villa Garda Hospital, University of California, San Francisco, St. Olavs Hospital, University Hospital of North Norway, Haukeland University Hospital, Vestre Viken Hospital Trust
- Study start
- 7 Mar 2024 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2033 (estimated)
- First posted
- 13 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E) | Experimental | Behavioral: Enhanced Cognitive-behavior therapy for adolescents with an eating disorderCBT-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) | Active comparator | Behavioral: Family-based therapy for adolescents with an eating disorderFBT 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. |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced Cognitive-behavior therapy for adolescents with an eating disorderPsychotherapy | Behavioural | Enhanced cognitive-behavior therapy for adolescents with an eating disorder (CBT-E) |
| Family-based therapy for adolescents with an eating disorderPsychotherapy | Behavioural | Family-based treatment for adolescents with an eating disorder (FBT) |
Primary outcome
Change in eating disorder psychopathology
Time frame: 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.
7 secondary outcomes
Change in eating disorder psychopathology
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).
Time frame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
Change in depression
Time frame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
Change in anxiety
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
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
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
Time frame: Baseline, immediately after the intervention, 6 months after the end of treatment, 12 months after the end of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Øyvind Rø, MD principal investigator
Oslo University Hospital
Ingrid Funderud, PhD principal investigator
Oslo University Hospital
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced Cognitive-behavior therapy for adolescents with an eating disorder and Family-based therapy for adolescents with an eating disorder in people with Feeding and Eating Disorders, run by Oslo University Hospital at 5 sites in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ingrid Funderud, PhD (+4723016230, ifunderu@ous-hf.no), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in eating disorder psychopathology (time frame: Baseline, immediately after the intervention.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Dec 2025.