VR-ACT After Stroke: a Feasibility Study

University of Coimbra

Status: Not yet enrolling

Conditions: Stroke; Chronic Pain

Treatments: Behavioral: Sham-VR; Behavioral: VR-ACT

Study type: Interventional

Funder types: Other

Identifiers

NCT06990646

2023.13402.PEX (Other Grant/Funding Number)

Details and patient eligibility

About

This exploratory project aims to develop and pilot test, in a parallel group randomized controlled trial (RCT) design, the feasibility, acceptability, and preliminary efficacy of a self-management virtual reality (VR) 8-week program for pain management and mental health in patients with chronic post-stroke pain (CPSP), in two assessment moments (pre- to post-intervention).

Full description

This project has three objectives: O1) to develop and test the feasibility and acceptability of a 8-week VR ACT program (VR-ACT) in a sample of CPSP patients; O2) to pilot test the efficacy of VR-ACT in improving pain, mental health, and adaptive psychological processes and skills, and in reducing the functional connectivity of the Triple Network (DMN, SN, and FPN); O3) To examine the cost-effectiveness of the VR-ACT. The current project will conduct a parallel group design Randomized Controlled Trial (RCT) and will follow a multi-method approach (qualitative and quantitative assessment).

Enrollment: 30 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• medical diagnosis of CPSP;
• age between 18 and 80;
• implicit de facto internet and computer literacy;
• willingness to comply with the study procedures.

Exclusion criteria

• currently with active malignancy; -
• severe cognitive impairment;
• currently undergoing any psychological intervention or VR-delivered pain management program;
• current severe psychiatric symptoms (i.e., psychosis; severe depression; non-suicidal self-injury; suicide attempt in the last month);
• language impairment with severe comprehension deficit;
• history of photosensitive epilepsy or previous experience of severe simulator sickness;
• other neurological conditions (e.g., dementia; Parkinson´s).

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 2 patient groups

VR-ACT

Experimental group

Description:

8 modules of 3D immersive skills training (2 targeting awareness regulation skills; 3 promoting acceptance; 3 focused on behavioral change and commitment to valued action)

Treatment:

Behavioral: VR-ACT

Sham-VR

Sham Comparator group

Description:

8 2D non-immersive distracting video animations delivered through a VR headset

Treatment:

Behavioral: Sham-VR