VR Therapy for Psychosis Negative Symptoms (V-NeST)

Schizophrenia Clinical Trial

— V-NeST  

Official title:

Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03995420
• Other study ID #: 260511
• Status: Recruiting
• Phase: N/A
• Start date: October 15, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: December 2019
• Source: Institute of Psychiatry, London
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: April 30, 2021
• Est. primary completion date: March 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Psychosis
• Psychotic Disorders
• Schizophrenia

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Institute of Psychiatry, King's College London	London

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Psychiatry, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the Goal Attainment Scale	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.	12 weeks