Clinical trial Recruiting at 1 site Interventional Ages 18 to 65

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 typeInterventional
Ages18 Years to 65 Years
SexAll
Enrollment256 (estimated)
SponsorHerlev and Gentofte Hospital
Academic / other
Locations1 site (Ballerup Municipality, Capital Region)
StatusRecruiting
StartedJune 10, 2024
Main results expectedDecember 2032
Study endsDecember 2032
Registry record updatedJuly 13, 2026
Trial IDNCT07698132 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

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.