PsychosisV-NeSTNCT03995420
VR Therapy for Psychosis Negative Symptoms (V-NeST)
A study testing Virtual Reality Therapy (V-NeST) and Treatment as Usual in people with Psychosis and Schizophrenia, run by Institute of Psychiatry, London at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychosis, Schizophrenia
- What is being tested?
- Virtual Reality Therapy (V-NeST) and Treatment as Usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 15 Oct 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Recent antipsychotic medication change (i.e. in the last 3 weeks);
- Moderate to severe learning disability
- Insufficient English for therapy
- Organic impairment.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Institute of Psychiatry, King's College London
London, SE5 8AF
Matteo Cella, PhD, (+44) 02-7 484 5001, matteo.cella@kcl.ac.uk
About this study
Official title: Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis
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).
Read more
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
- Being tested
- Virtual Reality Therapy (V-NeST), Treatment as Usual
- Medical subject headings
- Psychotic Disorders, Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Reality Therapy (V-NeST)Behavioural
V-NeST is a 12-session therapy using psychological intervention principles based on Cognitive Remediation and CBT partly based in Virtual Reality.
Treatment as UsualOther
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 group | Role | What they receive |
|---|---|---|
| Virtual Reality Therapy (V-NeST) | Experimental | Participants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU). Receives: 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. Receives: Other: Treatment as Usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2019
- Study start15 Oct 2019
- Primary completion30 Mar 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PsychosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institute of Psychiatry, London
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Matteo Cella, Institute of Psychiatry, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03995420
- Sponsor's protocol ID
- 260511
- Acronym
- V-NeST
- Status last verified
- Dec 2019
- First submitted
- 20 Jun 2019
- Last updated
- 6 Dec 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Still needs to be approved by the sponsor and funder
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis
- ClinicalTrials.gov ID
- NCT03995420
- Acronym / sponsor ID
- V-NeST / 260511
- Conditions
- Psychosis, Schizophrenia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Institute of Psychiatry, LondonUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- 30 Mar 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 24 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Virtual Reality Therapy (V-NeST) | Experimental | Behavioral: Virtual Reality Therapy (V-NeST), Other: Treatment as UsualParticipants in this arm will receive Virtual Reality Therapy (V-NeST) plus treatment as usual (TAU). |
| Treatment as Usual | Other | Other: Treatment as UsualParticipants in this arm will receive treatment as usual (TAU) only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- Recent antipsychotic medication change (i.e. in the last 3 weeks);
- Moderate to severe learning disability
- Insufficient English for therapy
- Organic impairment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Virtual Reality Therapy (V-NeST) |
| Treatment as Usualmulti-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. | Other | Treatment as Usual, Virtual Reality Therapy (V-NeST) |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2019.
- Individual participant dataSharing planned: Undecided. Still needs to be approved by the sponsor and funder
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Institute of Psychiatry, King's College London
London, United Kingdom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Reality Therapy (V-NeST) and Treatment as Usual in people with Psychosis and Schizophrenia, run by Institute of Psychiatry, London at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the Goal Attainment Scale (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2019.