VR-ACT After Stroke: a Feasibility Study

Not Applicable

Not yet recruiting

• Conditions: Chronic Pain; Stroke

• Registration Number: NCT06990646
• Lead Sponsor: University of Coimbra

Brief 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).

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-09
• Study First Submitted QC: 2025-05-21
• Last Update Submitted: 2025-05-21
• Study First Posted: 2025-05-25
• Last Update Posted: 2025-05-25
• Study Start: 2025-11
• Primary Completion: 2026-03
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	From enrollment to the end of treatment at 8 weeks	- The Numeric Rating Scale (NRS)
Pain Impact	From enrollment to the end of treatment at 8 weeks	- Pain Disability Index (PDI)
Mental Health	From enrollment to the end of treatment at 8 weeks	Mental Health: - Depression Anxiety and Stress Scale (DASS-21)
Psychological and Physical Quality of Life	From enrollment to the end of treatment at 8 weeks	- World Health Organization Quality of Life - Bref (WHOQOL- Bref)

Secondary Outcome Measures

Name	Time	Method
Mindful Awareness	From enrollment to the end of treatment at 8 weeks	Mindful Awareness: - Mindful Attention Awareness Scale (MAAS)
Emotional Regulation	From enrollment to the end of treatment at 8 weeks	Emotional Regulation: - Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
Psychological Flexibility	From enrollment to the end of treatment at 8 weeks	Psychological Flexibility: - Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)