VR Therapy for Psychosis Negative Symptoms (V-NeST)

Institute of Psychiatry, London

Status: Unknown

Conditions: Schizophrenia; Psychosis

Treatments: Behavioral: Virtual Reality Therapy (V-NeST); Other: Treatment as Usual

Study type: Interventional

Funder types: Other

Identifiers

NCT03995420

260511

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Virtual Reality Therapy (V-NeST)

Experimental group

Description:

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

Treatment:

Behavioral: Virtual Reality Therapy (V-NeST)

Other: Treatment as Usual

Treatment as Usual

Other group

Description:

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

Treatment:

Other: Treatment as Usual