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Clinical Trials/NCT03995420
NCT03995420
Unknown
Not Applicable

Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis

Institute of Psychiatry, London1 site in 1 country30 target enrollmentOctober 15, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Psychosis
Sponsor
Institute of Psychiatry, London
Enrollment
30
Locations
1
Primary Endpoint
the Goal Attainment Scale
Last Updated
6 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 15, 2019
End Date
April 30, 2021
Last Updated
6 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Institute of Psychiatry, London
Responsible Party
Principal Investigator
Principal Investigator

Matteo Cella

Principal Investigator

Institute of Psychiatry, London

Eligibility Criteria

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.

Outcomes

Primary Outcomes

the Goal Attainment Scale

Time Frame: 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.

Study Sites (1)

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