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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- University of Coimbra
- Enrollment
- 30
- Primary Endpoint
- Pain intensity
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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).
Arms & Interventions
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)
Intervention: VR-ACT (Behavioral)
Sham-VR
8 2D non-immersive distracting video animations delivered through a VR headset
Intervention: Sham-VR (Behavioral)
Outcomes
Primary Outcomes
Pain intensity
Time Frame: From enrollment to the end of treatment at 8 weeks
- The Numeric Rating Scale (NRS)
Pain Impact
Time Frame: From enrollment to the end of treatment at 8 weeks
- Pain Disability Index (PDI)
Mental Health
Time Frame: 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
Time Frame: From enrollment to the end of treatment at 8 weeks
- World Health Organization Quality of Life - Bref (WHOQOL- Bref)
Secondary Outcomes
- Mindful Awareness(From enrollment to the end of treatment at 8 weeks)
- Emotional Regulation(From enrollment to the end of treatment at 8 weeks)
- Psychological Flexibility(From enrollment to the end of treatment at 8 weeks)
Investigators
Sérgio Andrade Carvalho
Doctor
University of Coimbra