跳至主要内容
临床试验/NCT06993831
NCT06993831已完成不适用

ENGAGE Pilot Study: Alleviating Negative Symptoms in Schizophrenia Using a Virtual Reality-based Intervention Targeting Social Reward Learning

Mental Health Services in the Capital Region, Denmark1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年12月9日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Feasibility and acceptability as assessed by recruitment rate

研究概览

简要总结

The primary goal of this pilot study is to examine the feasibility and acceptability of a new Virtual Reality-based intervention against negative symptoms in schizophrenia spectrum disorders (SSD).

The main questions it aims to answer are:

  1. Is Virtual Reality-based therapy a feasible and acceptable treatment for negative symptoms in SSD?
  2. Are there indications that the treatment is effective in reducing negative symptoms, improving daily functioning, and enhancing quality of life?

Researchers will compare the new Virtual Reality-based treatment to standard psychiatric care to evaluate therapy effectiveness.

Participants will be allocated to receive either 10 sessions of Virtual Reality-based therapy or Treatment as usual. All participants will undergo a thorough assessment at baseline and at follow-up after 12 weeks.

详细描述

Negative symptoms (NS) are core features of schizophrenia and strongly correlated with vocational and social outcomes, quality of life, and have a higher impact on later outcome than positive symptoms (PS) such as hallucinations and delusions. While there are good medical treatment options for PS, no robust and replicated evidence exists for effective NS treatments. Consistent evidence suggests that abnormalities of the brain reward system are central in the pathogenesis of NS, i.e., the domains of anhedonia and avolition. Preliminary evidence indicates changes in reward learning following therapy is related to a reduction in NS.

Virtual reality (VR) is a promising technologically advanced mental health research tool with high ecological validity. VR allows individuals to immerse themselves in realistic environments and interact with virtual objects, providing a safe and controlled space to address symptoms and improve functioning. Initial evidence (N=4) supports that VR-based interventions significantly reduce NS and improve psychosocial functioning with a medium to large effect size. Given the suggested central role of reward processing disturbances in the pathogenesis of NS, there is an obvious need to investigate the effect of a VR-based intervention targeting reward processing in ameliorating NS.

Both NS and motivational abnormalities reflect complex processes at a system level likely corresponding to functional brain activity within and between several regions and circuits. Supplementing the clinical assessments in the study with magnetic resonance imaging (MRI) data may clarify whether the intervention directly targeting reward processing has an effect on the biological processes/networks involved.

In sum, this study will explore the prospects of using an innovative, VR-based treatment to treat NS and reward processing deficits in schizophrenia aimed at producing real-life benefits for the patients. If found successful, this pilot study could lay the foundation for a larger randomized clinical trial examining the intervention's effectiveness. Prospectively, these results can pave the way for a much sought-after treatment option for NS.

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)

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •ICD-10 diagnosis of a schizophrenia-spectrum disorder (F2x)
  • •Negative symptom score of ≥3 on the SANS items avolition or anhedonia

排除标准

  • •Diagnosis of organic brain disease
  • •Intellectual disability (IQ < 70)
  • •Current diagnosis of drug dependency
  • •Command of spoken Danish or English inadequate for engaging in therapy
  • •Refusing to be informed on incidental findings on the MRI scans

研究组 & 干预措施

Treatment as Usual

No Intervention

Participants randomized to this arm will not receive any treatment beyond the standard care offered by the usual health care providers.

VR-based psychotherapy

Experimental

Participants randomized to this arm will receive 10 sessions of the VR-based intervention targeting negative symptoms in schizophrenia in addition to any possible treatment offered by other health care providers.

干预措施: Virtual Reality-based psychotherapy (Behavioral)

结局指标

主要结局

Feasibility and acceptability as assessed by recruitment rate

时间窗: Recruitment rate is monitored throughout the study period (15 months)

Percentage of target sample (30 participants) recruited after 15 months from study start

Feasibility and acceptibility as assessed by retention rate

时间窗: Retention rates are monitored throughout the study period (15 months)

Percentage of included participants in the experimental group who retent to treatment at cessation of therapy (10 sessions)

Feasibility and acceptability as assessed by level of satisfaction in the experimental group

时间窗: At 12 weeks follow-up

Percentage of participants in the experimental group reporting a satisfaction rating of more than 7 on a 10-point Likert scale with higher scoring indicating a higher level of satisfaction with therapy.

次要结局

  • Severity of negative symptoms as assessed by the Brief Negative Symptoms Scale (BNSS)(Baseline and at 12 weeks follow-up)
  • Severity of negative symptoms as assessed by the Scale for the Assessment of Negative Symptoms (SANS)(Baseline and at 12 weeks follow-up)
  • Severity of negative symptoms as assessed by the Self-evaluation of Negative Symptoms (SNS)(Baseline and at 12 weeks follow-up)
  • Social and daily functioning as assessed by the Personal and Social Performance Scale (PSP)(Baseline and at 12 weeks follow-up)
  • Social functioning as assessed by the Social Functioning Scale (SFS)(Baseline and at 12 weeks follow-up)

研究者

发起方
Mental Health Services in the Capital Region, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验