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临床试验/NCT06677515
NCT06677515招募中不适用

Improving Social Functioning in People With Substance Use and Mental Health Disorders Using Virtual Reality (ROPVR): Study Protocol for a Multi-centre, Pragmatic Randomized Controlled Trial

Sykehuset Innlandet HF2 个研究点 分布在 1 个国家目标入组 102 人开始时间: 2025年5月8日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
102
试验地点
2
主要终点
Health and disability

研究概览

简要总结

ROPVR, a multi-centre, pragmatic randomized controlled trial (RCT) aims to evaluate a VR-technology which has been developed within an exploratory study and a development study, which facilitates social functioning among persons with a substance use and mental health disorder. Investigators will test a VR-program versus treatment as usual among patients enrolled into a long-term addiction-treatment facility. The RCT aims to evaluate the effectiveness of VR training compared to treatment as usual in improving resilience, quality of life, practical and social functioning and social participation (from baseline to 6 months), and to evaluate the cost-effectiveness of VR training versus treatment as usual.

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

入选标准

  • adults aged 18 years or older receiving in-patient SUD treatment in specialized addiction treatment units in South-East Norway. This may include persons serving prison sentences during in-patient treatment according to the Execution of Sentences Act in Norway
  • having the capability to read, understand and sign the Norwegian informed consent form
  • willing and able to attend VR training two times a week for 5 weeks

排除标准

  • significant visual, auditory, or balance impairment or other diseases affecting safety during VR sessions (e.g., epilepsy)
  • current clinically significant severe mental health disorder (e.g., acute episode of psychosis or current active suicidal plans). Persons with psychotic disorders or other severe mental illness are not excluded if their condition is stable.
  • severe travel sickness as a proxy for simulation sickness

研究组 & 干预措施

Virtual reality (VR) training

Experimental

Participants randomized to the intervention arm will attend VR sessions twice a week in 5 weeks, or 10 sessions in total. They will be placed into different virtual environments with increasing complexity, where they will be confronted with normal everyday situations in city environments.

In the first session, participants will receive instructions on using the head mounted display and navigating the scenarios. In three scenarios, participants are only observers, while in the remaining they can choose between several response options. These responses will be displayed on the screen, and participants can select their preferred response by pointing their finger to the chosen response alternative. The response alternatives are also provided verbally.

干预措施: VR training (Other)

Treatment as usual

No Intervention

Treatment of substance use disorders (SUD) is delivered by personnel with medical, psychological, and social expertise, meeting specialist-level healthcare standards. SUD treatment clinics offer patient-centred, interdisciplinary, holistic treatment focusing on physical, mental and social problems. Treatment often consists of both individual and group therapies and include activities (e.g., physical exercise, social activities) in the clinic as well as in external settings. Since treatment approaches and facilities may vary across clinics, patients' preferences or choice of clinic are emphasized. According to national guidelines, persons with SUD and co-occurring severe mental illness (i.e., schizophrenia or severe bipolar disorder) can receive treatment in SUD treatment clinics as long as their mental condition is stable. Otherwise, persons with SUD and severe mental illness receive treatment for both conditions within mental health services.

结局指标

主要结局

Health and disability

时间窗: From enrolement into the study until ca. 6 month

The primary outcome measure is disability measured with the 36-item WHO Disability Assessment Schedule (WHODAS 2.0) total score at 6 months post-intervention. WHODAS 2.0 measures health and disability in adults and captures the level of functioning in 6 domains: cognition, mobility, self-care, getting along, life activities and participation. The scores assigned to each of the items - "none" (1), "mild" (2) "moderate" (3), "severe" (4) and "extreme" (5) - are summed. Scores from each of the items are simply added up without recoding or collapsing of response categories; thus, there is no weighting of individual items. Higher sum score indicates more problems. WHODAS is based on the conceptual framework of the International Classification of Functioning. WHODAS is trans diagnostic, culturally sensitive and covers all diseases, including physical, mental and substance use disorders. It is is suitable for measuring the clinical effectiveness of interventions.

次要结局

  • Practical and social functioning(From enrolement into the study until ca. 6 month)
  • Social participation(From enrolement into the study until ca. 6 month)
  • Resilience(From enrolement into the study until ca. 6 month)
  • Cost-effectiveness(From enrolement into the study until ca. 12 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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