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临床试验/NCT03995420
NCT03995420Unknown不适用

Virtual Reality Supported Therapy for the Negative Symptoms of Psychosis

Institute of Psychiatry, London2 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2019年10月15日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
2
主要终点
the Goal Attainment Scale

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

Assessors will be blind to treatment allocation (single blind)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • Recent antipsychotic medication change (i.e. in the last 3 weeks);
  • Moderate to severe learning disability
  • Insufficient English for therapy
  • Organic impairment.

结局指标

主要结局

the Goal Attainment Scale

时间窗: 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.

次要结局

未报告次要终点

研究者

发起方
Institute of Psychiatry, London
申办方类型
Other
责任方
Principal Investigator
主要研究者

Matteo Cella

Principal Investigator

Institute of Psychiatry, London

研究点 (2)

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VR Therapy for Psychosis Negative Symptoms (V-NeST) | 临床试验