NCT03995420

VR Therapy for Psychosis Negative Symptoms (V-NeST)

Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Institute of Psychiatry, London · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Background: Negative symptoms are typically observed in people with schizophrenia and indicate a loss or reduction of a normal function (e.g. reduced motivation and affect display). Despite being important predictors of people's recovery the development of interventions for negative symptoms received only very limited attention. There are currently no evidenced based therapies for these symptoms. Aims: To test the feasibility and acceptability of a novel virtual reality assisted therapy, called Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis (V-NeST). Methods: This is a single (rater) blind randomised study with two conditions; V-NeST plus treatment-as-usual (TAU) vs. TAU alone. The study will recruit people with psychosis from NHS community care teams (in England). Assessments will be at baseline and 3-month post-randomisation. A nested qualitative study to identify the key themes associated with the acceptability of the overall study and intervention will be conducted. The study will assess key feasibility parameters such as: consent and availability for screening; eligibility; availability for assessment, randomisation and treatment retention. Acceptability will be assessed by considering: therapy session attendance and drop-out; in-depth feedback from service users interviews; acceptability of the research procedures and measures. Participants will be assessed with measures of functioning levels and, negative symptoms . Analyses will evaluate the feasibility and analyses of clinical outcomes will be focused on descriptive statistics and confidence intervals for treatment effects. Population variances of the main outcomes will be estimated for future power calculations. A semi-structured interview will explore participants' experience of being recruited to the study, receiving V-NeST and identify barriers (and potential solutions) to treatment engagement.

Conditions

• Psychosis
• Schizophrenia

Interventions

Type	Name	Description
BEHAVIORAL	Virtual Reality Therapy (V-NeST)	V-NeST is a 12-session therapy using psychological intervention principles based on Cognitive Remediation and CBT partly based in Virtual Reality.
OTHER	Treatment as Usual	multi-modal treatment consisting of different therapies defined by the treating team. These will include regular contact with a care coordinator and medication management by a psychiatrist.

Timeline

• Start date: 2019-10-15
• Primary completion: 2021-03-30
• Completion: 2021-04-30
• First posted: 2019-06-24
• Last updated: 2019-12-06

Locations

1 site across 1 country: United Kingdom