VR Therapy for Psychosis Negative Symptoms (V-NeST)

NCT03995420 | Unknown DMC

• 1 other identifier: 260511
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychosis; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Virtual Reality Therapy (V-NeST)

EXPERIMENTAL

Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU).

Behavioral: Virtual Reality Therapy (V-NeST); Other: Treatment as Usual

Treatment as Usual

OTHER

Participants in this arm will receive treatment as usual (TAU) only.

Other: Treatment as Usual

Interventions

Virtual Reality Therapy (V-NeST) BEHAVIORAL

V-NeST is a 12-session therapy using psychological intervention principles based on Cognitive Remediation and CBT partly based in Virtual Reality.

Virtual Reality Therapy (V-NeST)

Treatment as Usual OTHER

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.

Treatment as Usual; Virtual Reality Therapy (V-NeST)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Institute of Psychiatry, London: lead

Study Sites (1)

Institute of Psychiatry, King's College London

London, SE5 8AF, United Kingdom

RECRUITING

MeSH Terms

Conditions

Psychotic Disorders; Schizophrenia

Interventions

Virtual Reality Exposure Therapy; Therapeutics

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Desensitization, Psychologic; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be blind to treatment allocation (single blind)
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: October 15, 2019
• Primary Completion: March 30, 2021
• Study Completion: April 30, 2021
• Last Updated: December 6, 2019

Record last verified: 2019-12

Locations

GB (1)