Clinical trial NCT03995420: VR Therapy for Psychosis Negative Symptoms (V-NeST)
Official title: Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Psychosis
Schizophrenia
Lead sponsor: Institute of Psychiatry, London
Sponsor class: OTHER
First posted: 2019-06-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: the Goal Attainment Scale
timeFrame: 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Institute of Psychiatry, King's College London
Study officials:
References: