HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
HALO
1 other identifier
interventional
256
1 country
1
Brief 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 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 10, 2024
CompletedFirst Submitted
Initial submission to the registry
July 7, 2026
CompletedFirst Posted
Study publicly available on registry
July 13, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2032
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2032
July 13, 2026
July 1, 2026
8.5 years
July 7, 2026
July 7, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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)
At baseline and 4-8 weeks after end of therapy
World Health Organization Well-Being Index (WHO-5)
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)
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)
Baseline, at end of treatment at 20/21 weeks and at 6 months follow up.
The Beck Depression Inventory (BDI-II)
Baseline, at end of treatment at 20/21 weeks and at 6 months follow up.
Study Arms (4)
Cognitive Behavioural Therapy Enhanced - Individual
ACTIVE COMPARATORCognitive Behavioural Therapy Enhanced - Group
ACTIVE COMPARATORCognitive Behavioural Therapy Enhanced - Guided Self Help
ACTIVE COMPARATORManualized Treatment As Usual
ACTIVE COMPARATORInterventions
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 (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-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 (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.
Eligibility Criteria
You may qualify if:
- Binge Eating Disorder according to DSM-5 criteria
- years of age
- Fluent Danish speaker
You may not qualify if:
- 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
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev and Gentofte Hospitallead
- Jascha Fondencollaborator
- BETA-HEALTH Foundationcollaborator
- Region Capital Denmarkcollaborator
- University of Copenhagencollaborator
- Mental Health Centre Ballerupcollaborator
Study Sites (1)
Mental Health Centre Ballerup
Ballerup Municipality, Capital Region, 2750, Denmark
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Head of Research, Professor of Psychiatry
Study Record Dates
First Submitted
July 7, 2026
First Posted
July 13, 2026
Study Start
June 10, 2024
Primary Completion (Estimated)
December 1, 2032
Study Completion (Estimated)
December 1, 2032
Last Updated
July 13, 2026
Record last verified: 2026-07