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出境医 / 临床实验 / VR Therapy for Psychosis Negative Symptoms (V-NeST) (V-NeST)

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

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.


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

Study Design
Layout table for study information
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
Arms and Interventions
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.
Outcome Measures
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.



Eligibility Criteria
Layout table for eligibility information
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.
Contacts and Locations

Locations
Layout table for location information
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
Tracking Information
First Submitted Date  ICMJE June 20, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date December 6, 2019
Actual Study Start Date  ICMJE October 15, 2019
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 21, 2019) 		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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019) 		the Goal Attainment Scale [ Time Frame: 12 weeks ]
Measure assessing to degree of participant's individual goals achievement
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE VR Therapy for Psychosis Negative Symptoms (V-NeST)
Official Title  ICMJE Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Psychosis
  • Schizophrenia
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • Experimental: Virtual Reality Therapy (V-NeST)
    Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU).
    Interventions:
    • Behavioral: Virtual Reality Therapy (V-NeST)
    • Other: Treatment as Usual
  • Treatment as Usual
    Participants in this arm will receive treatment as usual (TAU) only.
    Intervention: Other: Treatment as Usual
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 20, 2019) 		30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2021
Estimated Primary Completion Date March 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Listed Location Countries  ICMJE United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995420
Other Study ID Numbers  ICMJE 260511
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: Still needs to be approved by the sponsor and funder
Responsible Party Matteo Cella, Institute of Psychiatry, London
Study Sponsor  ICMJE Institute of Psychiatry, London
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Institute of Psychiatry, London
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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