VR-ACT After Stroke: a Feasibility Study

NCT ID: NCT06990646

Last Updated: 2025-05-25

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2026-07-31

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).

Conditions

Chronic Pain; Stroke

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

VR-ACT

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)

Group Type: EXPERIMENTAL

VR-ACT

Intervention Type: BEHAVIORAL

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

Sham-VR

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

Group Type: SHAM_COMPARATOR

Sham-VR

Intervention Type: BEHAVIORAL

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

Interventions

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

Intervention Type: BEHAVIORAL

Sham-VR

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Unidade Local de Saúde de Coimbra, EPE

OTHER

Sponsor Role: collaborator

University of Coimbra

OTHER

Sponsor Role: lead

Responsible Party

Sérgio Andrade Carvalho

Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Sérgio A Carvalho, PhD

Role: CONTACT

sergiocarvalho@fpce.uc.pt

+351 239 851 450

Other Identifiers

2023.13402.PEX

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2023.13402.PEX

Identifier Type: -

Identifier Source: org_study_id