VR Therapy for Psychosis Negative Symptoms (V-NeST) (V-NeST)
Primary Purpose
Psychosis, Schizophrenia
Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Virtual Reality Therapy (V-NeST)
Treatment as Usual
Sponsored by
About this trial
This is an interventional treatment trial for Psychosis
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.
Sites / Locations
- Institute of Psychiatry, King's College LondonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Virtual Reality Therapy (V-NeST)
Treatment as Usual
Arm Description
Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU).
Participants in this arm will receive treatment as usual (TAU) only.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT03995420
First Posted
June 20, 2019
Last Updated
December 4, 2019
Sponsor
Institute of Psychiatry, London
1. Study Identification
Unique Protocol Identification Number
NCT03995420
Brief Title
VR Therapy for Psychosis Negative Symptoms (V-NeST)
Acronym
V-NeST
Official Title
Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
October 15, 2019 (Actual)
Primary Completion Date
March 30, 2021 (Anticipated)
Study Completion Date
April 30, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Institute of Psychiatry, London
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psychosis, Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized Controlled Trial
Masking
Outcomes Assessor
Masking Description
Assessors will be blind to treatment allocation (single blind)
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality Therapy (V-NeST)
Arm Type
Experimental
Arm Description
Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU).
Arm Title
Treatment as Usual
Arm Type
Other
Arm Description
Participants in this arm will receive treatment as usual (TAU) only.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Reality Therapy (V-NeST)
Intervention Description
V-NeST is a 12-session therapy using psychological intervention principles based on Cognitive Remediation and CBT partly based in Virtual Reality.
Intervention Type
Other
Intervention Name(s)
Treatment as Usual
Intervention Description
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.
Primary Outcome Measure Information:
Title
the Goal Attainment Scale
Description
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.
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Institute of Psychiatry, King's College London
City
London
ZIP/Postal Code
SE5 8AF
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Matteo Cella, PhD
Phone
(+44) 02-7 484 5001
Email
matteo.cella@kcl.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Still needs to be approved by the sponsor and funder
Learn more about this trial
VR Therapy for Psychosis Negative Symptoms (V-NeST)
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