The Dialogue Study: A Randomized Clinical Trial Investigating the Effect of a Virtual-reality Based Treatment for Eating Disorders

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The Dialogue Study is a randomized, assessor-blinded parallel-groups superiority clinical trial fulfilling the CONSORT criteria for non-pharmacological treatment. The aim of the trial is to investigate the effect of a new virtual reality based psychotherapy for eating disorders. A total of 96 participants with a diagnosis of anorexia nervosa or bulimia nervosa will be allocated to either Virtual-reality therapy plus treatment as usual or treatment as usual. All participants will be assessed at baseline and 12- and 24 months post baseline. A stratified block-randomisation with concealed randomisation sequence will be conducted. Independent assessors blinded to the treatment will evaluate outcome. Analysis of outcome will be carried out with the intention to treat principles.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• ≥ Age 18 of years

• Ability to give informed consent

• A diagnosis of eating disorder (ICD-10 code: F50.0 - F.50.3)

• Recognizing having an internal eating disorder voice

Locations
Other Locations
Denmark
Copenhagen Research Center for Mental Health - CORE
RECRUITING
Hellerup
Contact Information
Primary
Nina K Hansen, MSc (Psych.)
nina.kappel.hansen@regionh.dk
21699487
Backup
Louise B Glenthøj, DMSc, PhD
nina.kappel.hansen@regionh.dk
21452889
Time Frame
Start Date: 2024-02-26
Estimated Completion Date: 2026-06
Participants
Target number of participants: 96
Treatments
Experimental: Virtual-reality assisted therapy + treatment as usual
Seven sessions
Active_comparator: Treatment as usual (TAU)
Seven sessions
Related Therapeutic Areas
Sponsors
Leads: Mental Health Services in the Capital Region, Denmark

This content was sourced from clinicaltrials.gov