Chronic Pain, Stroke
Conditions
Keywords
chronic post-stroke pain, contextual-behavioral approaches, virtual reality, acceptance and commitment therapy
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).
Interventions
BEHAVIORALVR-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
BEHAVIORALSham-VR
8 2D non-immersive distracting video-animations delivered through a VR headset.
Sponsors
Unidade Local de Saúde de Coimbra, EPE
University of Coimbra
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Contacts
Primary ContactSérgio A Carvalho, PhD
Outcome results
None listed