Binge Eating DisorderHALONCT07698132
HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
A study testing Cognitive Behavioral Therapy Enhanced - Individual, Cognitive Behavioral Therapy Enhanced - Group and Cognitive Behavioral Therapy - Guided Self Help in people with Binge Eating Disorder and Binge Eating Episodes, run by Herlev and Gentofte Hospital at 1 site in Denmark.
Trial summary
The HALO trial is designed as a four-armed, assessor-blinded, fidelity-monitored randomized clinical trial. The goal of this randomized controlled study is to investigate the effectiveness of four different psychotherapy programs and to determine which one is most effective in reducing the number of binge-eating… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Binge Eating Disorder, Binge Eating Episodes, Binge Eating/Loss of Control Eating
- What is being tested?
- Cognitive Behavioral Therapy Enhanced - Individual, Cognitive Behavioral Therapy Enhanced - Group and Cognitive Behavioral Therapy - Guided Self Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteDenmark
- Study dates
- 10 Jun 2024to Dec 2032
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Binge Eating Disorder according to DSM-5 criteria
- 18-65 years of age
- Fluent Danish speaker
Who cannot join
- Concurrent psychotherapeutic treatment
- Use of weight loss medications within the last month (i.e., GLP-1 receptor antagonists)
- Suicidal ideation or suicidality
- Psychosis or psychotic disorders
- Mania or bipolar disorder
- Drug misuse disorder
Show all 9Show fewer
- Alcohol misuse disorder
- Cluster B personality disorders in the severe range (diagnosed)
- Dosage of Antidepressants, Antipsychotics and Stimulants must be stable for at least 6 months
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Mental Health Centre Ballerup
Ballerup Municipality, Capital Region, 2750
Linda Lloyd Hughes, MSc, 0045 21547768, bal-halo.region-hovedstadens-psykiatri@regionh.dk
About this study
The HALO trial is designed as a four-armed, assessor-blinded, fidelity-monitored randomized clinical trial. The goal of this randomized controlled study is to investigate the effectiveness of four different psychotherapy programs and to determine which one is most effective in reducing the number of binge-eating episodes in people with the eating disorder Binge Eating Disorder (BED), by directly comparing three intensities of Cognitive Behavioral Therapy-Enhanced against a manualized treatment as usual.
Participants will be asked to complete a 21-weeks randomized intervention and participate in follow up assesments.
Read the detailed description
The HALO trial is a investigator-initiated, four-arm, partially blinded, randomized controlled superiority trial evaluating the effectiveness of three formats and intensities of Cognitive Behavioral Therapy-Enhanced (CBT-E) compared with manualized treatment as usual (TAU) for adults with Binge Eating Disorder (BED).
BED is associated with substantial psychiatric and physical morbidity, and despite psychotherapy being the recommended first-line treatment, there is limited high-quality evidence directly comparing different CBT-E delivery formats compared with an active control intervention. The trial aims to determine whether individual CBT-E provides superior clinical outcomes compared with group CBT-E, CBT-E guided self-help, and manualized TAU.
A total of 256 participants with a primary diagnosis of BED will be recruited through Danish Mental Health Services and public advertisement. Following informed consent and baseline diagnostic assessments, eligible participants will be randomized in a 1:1:1:1 ratio to one of four treatment arms: (1) individual CBT-E, (2) group CBT-E, (3) therapist-guided CBT-E self-help, or (4) manualized group-based systemic narrative therapy delivered as treatment as usual. All interventions are delivered over a 21-week treatment period.
Diagnostic assessments include the Eating Disorder Examination interview to confirm the diagnosis of BED and the Mini International Neuropsychiatric Interview to assess psychiatric comorbidity and study eligibility. The primary outcome is change in binge eating frequency measured using the Eating Disorder Examination Questionnaire. Secondary outcomes include remission from BED assessed by the Eating Disorder Examination interview, overall eating disorder psychopathology (Eating Disorder Examination Questionnaire), psychological well-being (World Health Organization-Five Well-Being Index), work and social functioning (Work and Social Adjustment Scale), anxiety symptoms (State-Trait Anxiety Inventory), and depressive symptoms (Beck Depression Inventory-II).
In addition, a broad range of exploratory psychological, clinical, and psychosocial measures will be collected to investigate potential mechanisms of treatment response, predictors of outcome, and moderators and mediators of treatment effects (list of exploratory outcomes is available upon request). These exploratory measures are used only for hypothesis-generating and are not part of the primary efficacy analyses. Post-treatment diagnostic interviews are conducted by blinded outcome assessors. Due to the nature of the psychotherapeutic interventions, participants and therapists cannot be blinded to treatment allocation. Outcome assessors, statisticians, investigators responsible for data analysis, and the trial leadership remain blinded until completion of the primary analyses.
To ensure intervention fidelity, therapists receive standardized training and ongoing method-specific supervision throughout the trial. Treatment sessions are video-recorded, and a random sample (10%) will be independently assessed for adherence to the treatment manuals. Assessors receive regular supervision, and inter-rater reliability is monitored throughout the study.
Participant safety is monitored throughout the trial. Serious adverse events and clinically significant deterioration are documented according to predefined procedures. Participants identified as having severe depression or elevated suicide risk are managed according to standardized clinical safety procedures. All participants provide written informed consent prior to study participation.
Study data are collected and managed using the secure electronic data capture system REDCap, which complies with applicable data protection regulations. Data quality is ensured through standardized assessment procedures, predefined data collection protocols, electronic range and consistency checks, and regular monitoring of study procedures.
The primary analysis will follow the intention-to-treat principle, including all randomized participants according to their allocated treatment group regardless of treatment adherence. Continuous outcomes will be analyzed using mixed-effects regression models for repeated measures, while dichotomous outcomes will be analyzed using logistic regression models. Secondary outcome analyses will account for multiple testing where appropriate. Missing outcome data will be handled using likelihood-based mixed models under the missing-at-random assumption, with multiple imputation used for secondary analyses and missing baseline covariates. If substantial evidence suggests that data are Missing Not At Random, sensitivity analyses will be undertaken. A supplementary per-protocol analysis may be conducted if dropout exceeds assumptions used in the sample size calculation.
The planned sample size of 256 participants (64 per treatment arm) was based on a priori power calculations assuming a small-to-moderate treatment effect (Cohen's f = 0.20), a two-sided significance level of 0.05, and approximately 85% statistical power in the primary mixed-model repeated measures analysis, while accounting for an anticipated attrition rate of up to 30%. This sample size is expected to provide adequate power to detect clinically meaningful differences between treatment groups. With a planned sample size of 256 participants, the HALO trial is expected to be the largest randomized clinical trial of psychotherapy for BED conducted to date and will provide robust evidence regarding the comparative effectiveness of different CBT-E treatment formats and manualized treatment as usual.
- Conditions
- Binge Eating Disorder, Binge Eating Episodes, Binge Eating/Loss of Control Eating, Binge Eating Disorders, Binge Eating, Binge Eating Behaviour
- Being tested
- Cognitive Behavioral Therapy Enhanced - Individual, Cognitive Behavioral Therapy Enhanced - Group, Cognitive Behavioral Therapy - Guided Self Help, Systemic Narrative Therapy - Group
- Keywords
- Binge Eating Disorder, Eating Disorders, Cognitive Behavioral Therapy, Psychotherapy, Randomized Controlled Trial, Evidence-based Psychiatry
- Medical subject headings
- Binge-Eating Disorder, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy Enhanced - IndividualBehavioural
Cognitive Behavioral Therapy Enhanced (CBT-E) (individual) is delivered in 20, 50-minute sessions over 20 weeks, following four stages. Stage 1 (sessions 0-7) consists of twice-weekly sessions to establish treatment momentum, self-monitoring, and regular eating. Stages 2 (sessions 8-9) and 3 (sessions 10-17) are delivered weekly. Stage 2 focuses on reviewing progress and planning the remainder of treatment. In Stage 3, the therapist tailors treatment to the individual by selecting one or more modules addressing (1) body image, (2) dietary restraint, and (3) events, moods, and eating, while also covering setbacks and unhelpful mindsets. Stage 4 (sessions 18-20) is delivered fortnightly and focuses on ending therapy, maintaining progress, and relapse prevention. Each session follows a consistent structure, beginning with in-session weighing, followed by a review of self-monitoring records and homework, agenda setting, and work on the session's goals.
Cognitive Behavioral Therapy Enhanced - GroupBehavioural
Cognitive Behavioral Therapy Enhanced (group) is group therapy delivered in groups with eight participants and two therapists. The groups are closed, meaning the same eight participants start and finish at the same time. The course consists of one individual session before the group starts, and thereafter 20 weeks of weekly two-hour group sessions. A group manual has been developed by our research group (available upon request), based on 'Cognitive Behavior Therapy Enhanced for Eating Disorders' and 'Overcoming Binge Eating' .
Cognitive Behavioral Therapy - Guided Self HelpBehavioural
Cognitive Behavioral Therapy (guided self-help) is a therapist-assisted online treatment based on the principles of CBT-E (see above). Participants access the program from home and receive concurrent brief individual support sessions aimed at developing treatment goals, monitoring progress, and encouraging adherence to the program. The treatment begins with a one-hour face-to-face session with a therapist in week 1, followed by eight brief telephone sessions over the course of treatment: weekly calls during the first four weeks (weeks 2, 3, 4), then fortnightly calls for four weeks (weeks 6 and 8), and finally calls every third week until the end of therapy (weeks 11, 14, and 17). The treatment concludes with a one-hour face-to-face session with a therapist in week 20 focused on reviewing progress, maintaining gains, and relapse prevention. The online program was developed by Digital Psychiatry and adapted by our research group to adhere more closely to CBT-E principles.
Systemic Narrative Therapy - GroupBehavioural
Systemic Narrative Therapy (group) is the standard outpatient treatment for eating disorders within Mental Health Services of the Capital Region of Denmark. The intervention integrates principles of systemic and narrative psychotherapy and is delivered in groups of approximately eight participants by two therapists. Treatment consists of weekly 3.5-hour sessions over approximately 21 weeks, including individual weighing, a shared meal, and structured group psychotherapy. Therapeutic techniques include reflecting teams, collaborative exploration, and externalizing conversations to help participants separate themselves from the eating disorder and develop alternative narratives. The intervention also includes routine weight monitoring and dietary self-monitoring as part of standard clinical care.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioural Therapy Enhanced - Individual | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy Enhanced - Individual |
| Cognitive Behavioural Therapy Enhanced - Group | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy Enhanced - Group |
| Cognitive Behavioural Therapy Enhanced - Guided Self Help | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Therapy - Guided Self Help |
| Manualized Treatment As Usual | Active comparator | Not described Receives: Behavioral: Systemic Narrative Therapy - Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination Questionnaire (EDE-Q)
The primary outcome will be binge eating frequency which is measured by the EDE-Q. To meet the abstinence criteria in the current study there should be no binge eating episodes associated with the sense of loss of control in the past month. The EDE-Q is a 28-item questionnaire designed to assess severity of features associated with eating disorders. The EDE- Q has demonstrated good internal consistency, convergent and construct validity and test-retest reliability.
Measured: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.
Secondary outcomes (5)
Eating Disorder Examination Interview (EDE-17)
Eating Disorder Examination Interview (EDE-17) is a clinical semi-structured interview used to assess ED diagnoses and symptomatology. The 17th version of the EDE was used. Research shows adequate test-retest reliability for all four subscales of the EDE, and preliminary support has been found for the internal consistency. The interview is considered the gold standard ED assessment tool.
Measured: At baseline and 4-8 weeks after end of therapy
World Health Organization Well-Being Index (WHO-5)
The WHO-5 is a 5-item self-report measure assessing subjective well-being. Items are rated on a 6-point Likert scale. The measure has demonstrated satisfactory reliability, as well as convergent and factorial validity.
Measured: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.
The Work and Social Adjustment Scale (WSAS)
The WSAS assesses the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure, and personal or family relationships. This instrument is a 5-item scale. Each of the items is rated on a nine-point Likert scale, from 'Not at all' (0) to 'Severely impaired' (8). The measure shows good validity and reliability.
Measured: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.
State-Trait Anxiety Inventory (STAI)
The STAI is a 40-item self-report measure rated on a 4-point Likert scale that assesses two dimensions of anxiety: state anxiety and trait anxiety. In the present study, only the state anxiety subscale (20 items) was administered. Previous research has demonstrated satisfactory reliability and validity of the STAI across both research and clinical settings, supporting its use as a measure of anxiety symptoms.
Measured: Baseline, at end of treatment at 20/21 weeks and at 6 months follow up.
The Beck Depression Inventory (BDI-II)
The BDI-II is a 21-item self-report measure assessing the severity of depressive symptoms. The instrument was revised in 1996 to align more closely with DSM-IV criteria for depression. Previous research has demonstrated good internal consistency, convergent and discriminant validity, and test-retest reliability, supporting its use as a measure of depressive symptoms.
Measured: Baseline, at end of treatment at 20/21 weeks and at 6 months follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start10 Jun 2024
- Primary completionDec 2032 (estimated)
- Study completionDec 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herlev and Gentofte Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Jascha Fonden, BETA-HEALTH Foundation, Mental Health Centre Ballerup, Region Capital Denmark, University of Copenhagen
- Responsible party
- Principal investigator, Nadia Micali, MD, PhD, Herlev and Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698132
- Sponsor's protocol ID
- H-24002290
- Acronym
- HALO
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT07698132
- Acronym / sponsor ID
- HALO / H-24002290
- Conditions
- Binge Eating Disorder, Binge Eating Episodes, Binge Eating/Loss of Control Eating, Binge Eating Disorders, Binge Eating, Binge Eating Behaviour
- Keywords
- Binge Eating Disorder, Eating Disorders, Cognitive Behavioral Therapy, Psychotherapy, Randomized Controlled Trial, Evidence-based Psychiatry
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Herlev and Gentofte HospitalUniversity, hospital or other
- Collaborators
- Jascha Fonden, BETA-HEALTH Foundation, Mental Health Centre Ballerup, Region Capital Denmark, University of Copenhagen
- Study start
- 10 Jun 2024 (actual)
- Primary completion
- Dec 2032 (estimated)
- Study completion
- Dec 2032 (estimated)
- First posted
- 13 Jul 2026 (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 HALO trial is designed as a four-armed, assessor-blinded, fidelity-monitored randomized clinical trial. The goal of this randomized controlled study is to investigate the effectiveness of four different psychotherapy programs and to determine which one is most effective in reducing the number of binge-eating episodes in people with the eating disorder Binge Eating Disorder (BED), by directly comparing three intensities of Cognitive Behavioral Therapy-Enhanced against a manualized treatment as usual.
Participants will be asked to complete a 21-weeks randomized intervention and participate in follow up assesments.
Detailed description
The HALO trial is a investigator-initiated, four-arm, partially blinded, randomized controlled superiority trial evaluating the effectiveness of three formats and intensities of Cognitive Behavioral Therapy-Enhanced (CBT-E) compared with manualized treatment as usual (TAU) for adults with Binge Eating Disorder (BED).
BED is associated with substantial psychiatric and physical morbidity, and despite psychotherapy being the recommended first-line treatment, there is limited high-quality evidence directly comparing different CBT-E delivery formats compared with an active control intervention. The trial aims to determine whether individual CBT-E provides superior clinical outcomes compared with group CBT-E, CBT-E guided self-help, and manualized TAU.
A total of 256 participants with a primary diagnosis of BED will be recruited through Danish Mental Health Services and public advertisement. Following informed consent and baseline diagnostic assessments, eligible participants will be randomized in a 1:1:1:1 ratio to one of four treatment arms: (1) individual CBT-E, (2) group CBT-E, (3) therapist-guided CBT-E self-help, or (4) manualized group-based systemic narrative therapy delivered as treatment as usual. All interventions are delivered over a 21-week treatment period.
Diagnostic assessments include the Eating Disorder Examination interview to confirm the diagnosis of BED and the Mini International Neuropsychiatric Interview to assess psychiatric comorbidity and study eligibility. The primary outcome is change in binge eating frequency measured using the Eating Disorder Examination Questionnaire. Secondary outcomes include remission from BED assessed by the Eating Disorder Examination interview, overall eating disorder psychopathology (Eating Disorder Examination Questionnaire), psychological well-being (World Health Organization-Five Well-Being Index), work and social functioning (Work and Social Adjustment Scale), anxiety symptoms (State-Trait Anxiety Inventory), and depressive symptoms (Beck Depression Inventory-II).
In addition, a broad range of exploratory psychological, clinical, and psychosocial measures will be collected to investigate potential mechanisms of treatment response, predictors of outcome, and moderators and mediators of treatment effects (list of exploratory outcomes is available upon request). These exploratory measures are used only for hypothesis-generating and are not part of the primary efficacy analyses. Post-treatment diagnostic interviews are conducted by blinded outcome assessors. Due to the nature of the psychotherapeutic interventions, participants and therapists cannot be blinded to treatment allocation. Outcome assessors, statisticians, investigators responsible for data analysis, and the trial leadership remain blinded until completion of the primary analyses.
To ensure intervention fidelity, therapists receive standardized training and ongoing method-specific supervision throughout the trial. Treatment sessions are video-recorded, and a random sample (10%) will be independently assessed for adherence to the treatment manuals. Assessors receive regular supervision, and inter-rater reliability is monitored throughout the study.
Participant safety is monitored throughout the trial. Serious adverse events and clinically significant deterioration are documented according to predefined procedures. Participants identified as having severe depression or elevated suicide risk are managed according to standardized clinical safety procedures. All participants provide written informed consent prior to study participation.
Study data are collected and managed using the secure electronic data capture system REDCap, which complies with applicable data protection regulations. Data quality is ensured through standardized assessment procedures, predefined data collection protocols, electronic range and consistency checks, and regular monitoring of study procedures.
The primary analysis will follow the intention-to-treat principle, including all randomized participants according to their allocated treatment group regardless of treatment adherence. Continuous outcomes will be analyzed using mixed-effects regression models for repeated measures, while dichotomous outcomes will be analyzed using logistic regression models. Secondary outcome analyses will account for multiple testing where appropriate. Missing outcome data will be handled using likelihood-based mixed models under the missing-at-random assumption, with multiple imputation used for secondary analyses and missing baseline covariates. If substantial evidence suggests that data are Missing Not At Random, sensitivity analyses will be undertaken. A supplementary per-protocol analysis may be conducted if dropout exceeds assumptions used in the sample size calculation.
The planned sample size of 256 participants (64 per treatment arm) was based on a priori power calculations assuming a small-to-moderate treatment effect (Cohen's f = 0.20), a two-sided significance level of 0.05, and approximately 85% statistical power in the primary mixed-model repeated measures analysis, while accounting for an anticipated attrition rate of up to 30%. This sample size is expected to provide adequate power to detect clinically meaningful differences between treatment groups. With a planned sample size of 256 participants, the HALO trial is expected to be the largest randomized clinical trial of psychotherapy for BED conducted to date and will provide robust evidence regarding the comparative effectiveness of different CBT-E treatment formats and manualized treatment as usual.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioural Therapy Enhanced - Individual | Active comparator | Behavioral: Cognitive Behavioral Therapy Enhanced - Individual |
| Cognitive Behavioural Therapy Enhanced - Group | Active comparator | Behavioral: Cognitive Behavioral Therapy Enhanced - Group |
| Cognitive Behavioural Therapy Enhanced - Guided Self Help | Active comparator | Behavioral: Cognitive Behavioral Therapy - Guided Self Help |
| Manualized Treatment As Usual | Active comparator | Behavioral: Systemic Narrative Therapy - Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Binge Eating Disorder according to DSM-5 criteria
- 18-65 years of age
- Fluent Danish speaker
Key exclusion criteria (9 listed)
- Concurrent psychotherapeutic treatment
- Use of weight loss medications within the last month (i.e., GLP-1 receptor antagonists)
- Suicidal ideation or suicidality
- Psychosis or psychotic disorders
- Mania or bipolar disorder
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 |
|---|---|---|
| Cognitive Behavioral Therapy Enhanced - IndividualCognitive Behavioral Therapy Enhanced (CBT-E) (individual) is delivered in 20, 50-minute sessions over 20 weeks, following four stages. Stage 1 (sessions 0-7) consists of twice-weekly sessions to establish treatment momentum, self-monitoring, and regular eating. Stages 2 (sessions 8-9) and 3 (sessions 10-17) are delivered weekly. Stage 2 focuses on reviewing progress and planning the remainder of treatment. In Stage 3, the therapist tailors treatment to the individual by selecting one or more modules addressing (1) body image, (2) dietary restraint, and (3) events, moods, and eating, while also covering setbacks and unhelpful mindsets. Stage 4 (sessions 18-20) is delivered fortnightly and focuses on ending therapy, maintaining progress, and relapse prevention. Each session follows a consistent structure, beginning with in-session weighing, followed by a review of self-monitoring records and homework, agenda setting, and work on the session's goals. | Behavioural | Cognitive Behavioural Therapy Enhanced - Individual |
| Cognitive Behavioral Therapy Enhanced - GroupCognitive Behavioral Therapy Enhanced (group) is group therapy delivered in groups with eight participants and two therapists. The groups are closed, meaning the same eight participants start and finish at the same time. The course consists of one individual session before the group starts, and thereafter 20 weeks of weekly two-hour group sessions. A group manual has been developed by our research group (available upon request), based on 'Cognitive Behavior Therapy Enhanced for Eating Disorders' and 'Overcoming Binge Eating' . | Behavioural | Cognitive Behavioural Therapy Enhanced - Group |
| Cognitive Behavioral Therapy - Guided Self HelpCognitive Behavioral Therapy (guided self-help) is a therapist-assisted online treatment based on the principles of CBT-E (see above). Participants access the program from home and receive concurrent brief individual support sessions aimed at developing treatment goals, monitoring progress, and encouraging adherence to the program. The treatment begins with a one-hour face-to-face session with a therapist in week 1, followed by eight brief telephone sessions over the course of treatment: weekly calls during the first four weeks (weeks 2, 3, 4), then fortnightly calls for four weeks (weeks 6 and 8), and finally calls every third week until the end of therapy (weeks 11, 14, and 17). The treatment concludes with a one-hour face-to-face session with a therapist in week 20 focused on reviewing progress, maintaining gains, and relapse prevention. The online program was developed by Digital Psychiatry and adapted by our research group to adhere more closely to CBT-E principles. | Behavioural | Cognitive Behavioural Therapy Enhanced - Guided Self Help |
| Systemic Narrative Therapy - GroupSystemic Narrative Therapy (group) is the standard outpatient treatment for eating disorders within Mental Health Services of the Capital Region of Denmark. The intervention integrates principles of systemic and narrative psychotherapy and is delivered in groups of approximately eight participants by two therapists. Treatment consists of weekly 3.5-hour sessions over approximately 21 weeks, including individual weighing, a shared meal, and structured group psychotherapy. Therapeutic techniques include reflecting teams, collaborative exploration, and externalizing conversations to help participants separate themselves from the eating disorder and develop alternative narratives. The intervention also includes routine weight monitoring and dietary self-monitoring as part of standard clinical care. | Behavioural | Manualized Treatment As Usual |
Primary outcome
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.
The primary outcome will be binge eating frequency which is measured by the EDE-Q. To meet the abstinence criteria in the current study there should be no binge eating episodes associated with the sense of loss of control in the past month. The EDE-Q is a 28-item questionnaire designed to assess severity of features associated with eating disorders. The EDE- Q has demonstrated good internal consistency, convergent and construct validity and test-retest reliability.
5 secondary outcomes
Eating Disorder Examination Interview (EDE-17)
Time frame: At baseline and 4-8 weeks after end of therapy
World Health Organization Well-Being Index (WHO-5)
Time frame: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.
The Work and Social Adjustment Scale (WSAS)
Time frame: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.
State-Trait Anxiety Inventory (STAI)
Time frame: Baseline, at end of treatment at 20/21 weeks and at 6 months follow up.
The Beck Depression Inventory (BDI-II)
Time frame: Baseline, at end of treatment at 20/21 weeks and at 6 months follow up.
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 13 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Mental Health Centre Ballerup
Ballerup Municipality, Denmark
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy Enhanced - Individual, Cognitive Behavioral Therapy Enhanced - Group and Cognitive Behavioral Therapy - Guided Self Help in people with Binge Eating Disorder and Binge Eating Episodes, run by Herlev and Gentofte Hospital at 1 site in Denmark.
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 3 inclusion and 9 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 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination Questionnaire (EDE-Q) (time frame: Baseline, at end of treatment at 20/21 weeks, at 6 months follow up, at 1 year follow up, at 2 year follow up, at 3 year follow up, at 4 year follow up, at 5 year follow up.). 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 13 Jul 2026.