Clinical trial NCT06990646: VR-ACT After Stroke: a Feasibility Study
Official title: 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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chronic Pain
Stroke
Keywords: chronic post-stroke pain
contextual-behavioral approaches
virtual reality
acceptance and commitment therapy
Lead sponsor: University of Coimbra
Sponsor class: OTHER
Collaborators: name: Centro Hospitalar e Universitário de Coimbra, E.P.E.
First posted: 2025-05-25
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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).

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).

Primary outcomes:
measure: Pain intensity
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Pain Impact
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Mental Health
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Psychological and Physical Quality of Life
timeFrame: From enrollment to the end of treatment at 8 weeks
Secondary outcomes:
measure: Mindful Awareness
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Emotional Regulation
timeFrame: From enrollment to the end of treatment at 8 weeks
measure: Psychological Flexibility
timeFrame: From enrollment to the end of treatment at 8 weeks
Other outcomes:
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