HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder (NCT07698132) | Clinical Trial Compass
RecruitingNot Applicable
HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder
Denmark256 participantsStarted 2024-06-10
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Eating Disorder Examination Questionnaire (EDE-Q)
Timeframe: 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.