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.
Binge Eating Disorder according to DSM-5 criteria
18-65 years of age
Fluent Danish speaker
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
Parallel
Cognitive Behavioral Therapy Enhanced - Individual
BehavioralCognitive 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
BehavioralCognitive 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
BehavioralCognitive 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
BehavioralSystemic 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.
Eating Disorder Examination Questionnaire (EDE-Q)
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.
Eating Disorder Examination Interview (EDE-17)
Eating Disorder Examination Interview (EDE-17) is a clinical semi-structured interview used to assess ED diagnoses and symptomatology. The 17th version of the EDE was used. Research shows adequate test-retest reliability for all four subscales of the EDE, and preliminary support has been found for the internal consistency. The interview is considered the gold standard ED assessment tool.
World Health Organization Well-Being Index (WHO-5)
The WHO-5 is a 5-item self-report measure assessing subjective well-being. Items are rated on a 6-point Likert scale. The measure has demonstrated satisfactory reliability, as well as convergent and factorial validity.
The Work and Social Adjustment Scale (WSAS)
The WSAS assesses the impact of a person's mental health difficulties on their ability to function in terms of work, home management, social leisure, private leisure, and personal or family relationships. This instrument is a 5-item scale. Each of the items is rated on a nine-point Likert scale, from 'Not at all' (0) to 'Severely impaired' (8). The measure shows good validity and reliability.
State-Trait Anxiety Inventory (STAI)
The STAI is a 40-item self-report measure rated on a 4-point Likert scale that assesses two dimensions of anxiety: state anxiety and trait anxiety. In the present study, only the state anxiety subscale (20 items) was administered. Previous research has demonstrated satisfactory reliability and validity of the STAI across both research and clinical settings, supporting its use as a measure of anxiety symptoms.
Click on the lead sponsor to view all of their trials.
Herlev and Gentofte Hospital
Lead sponsor
Jascha Fonden
Collaborator
BETA-HEALTH Foundation
Collaborator
Mental Health Centre Ballerup
Collaborator
Region Capital Denmark
Collaborator
University of Copenhagen
Collaborator
