Four CBT-E formats for Binge Eating Disorder in adults
Official title: HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
Run by Herlev and Gentofte Hospital · NCT07698132 · Data updated 2026-11-12
This trial tests four different psychotherapy formats to see which best reduces binge-eating episodes in adults with Binge Eating Disorder.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 256 (estimated) |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Ballerup Municipality, Capital Region) |
| Status | Recruiting |
| Started | June 10, 2024 |
| Main results expected | December 2032 |
| Study ends | December 2032 |
| Registry record updated | July 13, 2026 |
| Trial ID | NCT07698132 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with a DSM-5 diagnosis of Binge Eating Disorder who are fluent in Danish and not currently receiving other psychotherapy.
✕Probably not a fit
Individuals with active suicidality, psychosis, severe mood or substance use disorders, or unstable psychotropic medication regimens are excluded and may not benefit from this trial.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a four-arm, assessor-blinded randomized controlled trial comparing three forms of Cognitive Behavioral Therapy-Enhanced (individual, group, and therapist-guided self-help) with a manualized treatment-as-usual control (group-based systemic narrative therapy) for adults with BED. Participants undergo a 21-week treatment period with follow-up assessments to evaluate changes in binge-eating episodes and related outcomes. The study aims to determine which delivery format of CBT-E provides the strongest clinical benefit when compared with an active control. Recruitment targets 256 participants diagnosed with BED, recruited from Danish mental health services and public outreach. Diagnostic confirmation uses the Eating Disorder Examination and Mini-International Neuropsychiatric Interview as part of eligibility assessment.
Why it matters
Potential benefit: If successful, the trial could identify the most effective CBT-E delivery format for reducing binge-eating episodes in BED, guiding clinical practice.
How similar studies have gone: Prior research supports CBT-E for BED, but direct head-to-head comparisons of multiple delivery formats against an active control are limited and this trial adds novel comparative data.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Binge Eating Disorder according to DSM-5 criteria * 18-65 years of age * Fluent Danish speaker Exclusion Criteria: * 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
Where it's running
-
Mental Health Centre Ballerup
Ballerup Municipality, Capital Region, Denmark Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.