NCT06990646

VR-ACT After Stroke: a Feasibility Study

VR-ACT After Stroke: a Feasibility RCT of a Virtual Reality Delivery of ACT for Pain Management and Mental Health in Patients With Chronic Post-Stroke Pain

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: University of Coimbra · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed 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).

Conditions

• Chronic Pain
• Stroke

Interventions

Type	Name	Description
BEHAVIORAL	VR-ACT	8 MODULES OF 3D VIRTUAL REALITY Modules 1 \& 2: Awareness Regulation Skills Modules 3, 4 \& 5: Acceptance of Pain and Internal Experiences Modules 6, 7 \& 8: Behavior Change and Valued Action
BEHAVIORAL	Sham-VR	8 2D non-immersive distracting video-animations delivered through a VR headset.

Timeline

• Start date: 2025-11-01
• Primary completion: 2026-03-01
• Completion: 2026-07-01
• First posted: 2025-05-25
• Last updated: 2025-05-25