Schizophrenia Clinical Trial
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).
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.
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