ENGAGE Pilot Study: Alleviating Negative Symptoms in Schizophrenia Using a Virtual Reality-based Intervention Targeting Social Reward Learning
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:
- Is Virtual Reality-based therapy a feasible and acceptable treatment for negative symptoms in SSD?
- 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
Participants randomized to this arm will not receive any treatment beyond the standard care offered by the usual health care providers.
VR-based psychotherapy
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)
