NCT07698132 HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
| NCT ID | NCT07698132 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Herlev and Gentofte Hospital |
| Condition | Binge Eating Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 256 participants |
| Start Date | 2024-06-10 |
| Primary Completion | 2032-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 256 participants in total. It began in 2024-06-10 with a primary completion date of 2032-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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
Frequently Asked Questions
Who can join the NCT07698132 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Binge Eating Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07698132 currently recruiting?
Yes, NCT07698132 is actively recruiting participants. Visit ClinicalTrials.gov or contact Herlev and Gentofte Hospital to inquire about joining.
Where is the NCT07698132 trial being conducted?
This trial is being conducted at Ballerup Municipality, Denmark.
Who is sponsoring the NCT07698132 clinical trial?
NCT07698132 is sponsored by Herlev and Gentofte Hospital. The trial plans to enroll 256 participants.