VR Therapy for Psychosis Negative Symptoms (V-NeST)

Not Applicable

• Conditions: Psychosis; Schizophrenia
• Interventions: Behavioral: Virtual Reality Therapy (V-NeST); Other: Treatment as Usual

• Registration Number: NCT03995420
• Lead Sponsor: Institute of Psychiatry, London

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-06-20
• Study First Submitted QC: 2019-06-20
• Study First Posted: 2019-06-24
• Study Start: 2019-10-15
• Status Verified: 2019-12
• Last Update Submitted: 2019-12-04
• Last Update Posted: 2019-12-06
• Primary Completion: 2021-03-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Service users currently under the care of NHS psychosis services;
• Aged over 18;
• in a stable clinical condition (as judged by primary clinician)
• with a documented episode of psychosis and/or a diagnosis of schizophrenia.

Exclusion Criteria

• Recent antipsychotic medication change (i.e. in the last 3 weeks);
• Moderate to severe learning disability
• Insufficient English for therapy
• Organic impairment.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Virtual Reality Therapy (V-NeST)	Virtual Reality Therapy (V-NeST)	Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU).
Virtual Reality Therapy (V-NeST)	Treatment as Usual	Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU).
Treatment as Usual	Treatment as Usual	Participants in this arm will receive treatment as usual (TAU) only.

Primary Outcome Measures

Name	Time	Method
the Goal Attainment Scale	12 weeks	Measure assessing to degree of participant's individual goals achievement; Full description of the measure and scoring can be obtained from the reference below: Logan TK. Goal Attainment Scaling - Applications, Theory, and Measurement - Kiresuk,Tj, Smith,a, Cardillo,Je. Contemp Psychol. 1995;40(10):984-5.; Baggio L, Buckley DJ. Detecting change in patient outcomes in a rural ambulatory rehabilitation service: the responsiveness of Goal Attainment Scaling and the Lawton Scale. Aust Health Rev. 2016;40(1):63-8.; Ng BF, Tsang HW. Evaluation of a Goal Attainment Program using the Goal Attainment Scale for Psychiatric In-patients in vocational rehabilitation. Work. 2000;14(3):209-16.

Trial Locations

Locations (1)

Institute of Psychiatry, King's College London; 🇬🇧 London, United Kingdom