VR-ACT After Stroke: a Feasibility Study

N/ANot Yet RecruitingNCT06990646

University of Coimbra30 enrolled

Overview

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).

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Chronic Pain Stroke

Interventions

VR-ACTBEHAVIORAL

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-VRBEHAVIORAL

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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).