HALO-TRIAL: High, Medium And LOw Intensity Psychotherapy for Binge Eating Disorder

Condition(s) studied

Investigational drug(s) / intervention(s)

Cognitive Behavioral Therapy Enhanced - Individual: 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: 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: 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: 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.

Study 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

Primary outcome measure(s)

• Eating Disorder Examination Questionnaire (EDE-Q) — 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 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.

Trial sites (1)

More Herlev and Gentofte Hospital trials in Denmark

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