THRIVE:Virtual Reality treatment for building confidence around people
Research type
Research Study
Full title
The THRIVE study: A randomized controlled trial comparing Virtual Reality Confidence Building with VR Mental Relaxation for people with fears about others.
IRAS ID
239628
Contact name
Daniel Freeman
Contact email
Sponsor organisation
University of Oxford
Duration of Study in the UK
2 years, 2 months, 29 days
Research summary
Persecutory delusions (strong unfounded fears that others intend harm) occur in over 70% of patients with schizophrenia. They are highly distressing and associated with significant cost to the NHS. Many patients do not adequately respond to current treatments or have access to effective psychological interventions.
The applicant has developed a theoretical model of persecutory delusions; they are viewed as threat beliefs. Therefore, the treatment goal is for patients to enter feared situations, drop distress-maintaining safety behaviours, and relearn safety. Patients often find this too difficult. A solution is virtual reality (VR); this is easier than real situations, however, responses are comparable and learning transfers into everyday life. The research team’s previous pilot work showed a one-session VR treatment produced large improvements in persecutory delusions. This treatment needs to be further developed into a more affordable, portable, and efficacious version (VR Confidence Building; VRCB) and then tested with a larger sample of patients.
The key question is: Does VRCB lead to greater reduction in delusional conviction, and improvements in activity levels, quality of life, and suicidal ideation, compared to the control condition (VR mental relaxation; VRMR)?
To test this, patients with persecutory delusions will be randomly allocated to receive either four sessions of VRCB or VRMR. Assessments, by raters blind to allocation, will be conducted at 0, 2, 4 (post-treatment), 8, 16, and 24 weeks. We will conduct an interim analysis after 30 patients; if this shows the treatment is worth pursuing, we will continue the trial, testing 90 patients in total. Medication prescription will continue as usual.
The trial is funded by the Medical Research Council Developmental Pathway Funding Scheme.
The trial aims to assess treatment efficacy. However, as VRCB comes under medical devices regulations, a Notice of No Objection will be sought for using this treatment in the trial.
REC name
South Central - Oxford B Research Ethics Committee
REC reference
18/SC/0316
Date of REC Opinion
11 Jul 2018
REC opinion
Further Information Favourable Opinion