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VR Therapy for Psychosis Negative Symptoms (V-NeST) (V-NeST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995420
Recruitment Status : Recruiting
First Posted : June 24, 2019
Last Update Posted : December 6, 2019
Sponsor:
Information provided by (Responsible Party):
Matteo Cella, 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.


Condition or disease Intervention/treatment Phase
Psychosis Schizophrenia Behavioral: Virtual Reality Therapy (V-NeST) Other: Treatment as Usual Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized Controlled Trial
Masking: Single (Outcomes Assessor)
Masking Description: Assessors will be blind to treatment allocation (single blind)
Primary Purpose: Treatment
Official Title: Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis
Actual Study Start Date : October 15, 2019
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : April 30, 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. 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.




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995420


Locations
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United Kingdom
Institute of Psychiatry, King's College London Recruiting
London, United Kingdom, SE5 8AF
Contact: Matteo Cella, PhD    (+44) 02-7 484 5001    matteo.cella@kcl.ac.uk   
Sponsors and Collaborators
Institute of Psychiatry, London
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Responsible Party: Matteo Cella, Principal Investigator, Institute of Psychiatry, London
ClinicalTrials.gov Identifier: NCT03995420    
Other Study ID Numbers: 260511
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Still needs to be approved by the sponsor and funder

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Schizophrenia
Psychotic Disorders
Mental Disorders
Schizophrenia Spectrum and Other Psychotic Disorders