Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06345040
Status:
RECRUITING
Last Update Posted:
2024-04-03
First Post:
2024-03-14
Brief Title:
The Dialogue Study A Virtual-reality Based Treatment for Eating Disorders
Sponsor:
Mental Health Services in the Capital Region Denmark
Organization:
Mental Health Services in the Capital Region Denmark
Study Overview
Official Title:
The Dialogue Study A Randomized Clinical Trial Investigating the Effect of a Virtual-reality Based Treatment for Eating Disorders
Status:
RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Eating disorders can be defined as pathological eating habits and a tendency to overestimate weight and body shape It affects at least 7 of the global population and has profound physical and psychological costs for the affected individual comprising a high risk of relapse and death Additionally eating disorders are associated with a significant economic burden in terms of health care costs and lower employment rates
There is considerable interest in the development of novel psychological interventions for eating disorders which are more effective and which target characteristics that could potentially serve as maintaining factors in eating disorder pathology The majority 94 of patients with an eating disorder report experiencing a dominant critical internal voice commenting on weight and self-worth often referred to as the eating disorder voice
Within psychotic disorders a virtual reality-based therapy termed avatar therapy has proven highly effective in reducing the power of the psychotic voice and consequently alleviating the associated distress Building on this evidence we have developed a modified version of the avatar treatment protocol targeting patients with an eating disorder
The objective of the Dialogue Study is to identify whether this virtual reality-based therapy can reduce symptoms improve quality of life and be cost-effective in treating patients with an eating disorder Two feasibility studies have found the intervention to be feasible and acceptable for individuals with an eating disorder Evidence on the efficacy of the intervention now needs to be tested in a large methodological rigorous trial If the results of the randomized clinical trial are positive it may motivate scalability and potential implementation in the clinics treating adults with an eating disorder
There is considerable interest in the development of novel psychological interventions for eating disorders which are more effective and which target characteristics that could potentially serve as maintaining factors in eating disorder pathology The majority 94 of patients with an eating disorder report experiencing a dominant critical internal voice commenting on weight and self-worth often referred to as the eating disorder voice
Within psychotic disorders a virtual reality-based therapy termed avatar therapy has proven highly effective in reducing the power of the psychotic voice and consequently alleviating the associated distress Building on this evidence we have developed a modified version of the avatar treatment protocol targeting patients with an eating disorder
The objective of the Dialogue Study is to identify whether this virtual reality-based therapy can reduce symptoms improve quality of life and be cost-effective in treating patients with an eating disorder Two feasibility studies have found the intervention to be feasible and acceptable for individuals with an eating disorder Evidence on the efficacy of the intervention now needs to be tested in a large methodological rigorous trial If the results of the randomized clinical trial are positive it may motivate scalability and potential implementation in the clinics treating adults with an eating disorder
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None