Improving Social Functioning in People With Substance Use and Mental Health Disorders Using VR (ROPVR)

Sykehuset Innlandet HF

Status: Enrolling

Conditions: Mental Disorder; Substance Use Disorders

Treatments: Other: VR training

Study type: Interventional

Funder types: Other

Identifiers

NCT06677515

326773VR_WP3

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

Virtual reality (VR) training

Experimental group

Description:

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.

Treatment:

Other: VR training

Treatment as usual

No Intervention group

Description:

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.