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NCT Number: NCT06990646

VR-ACT After Stroke: a Feasibility Study

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).

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Key information

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

VR-ACT

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

Behavioral

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

Primary outcomes

  1. Pain intensity

    Time frame: From enrollment to the end of treatment at 8 weeks

    • The Numeric Rating Scale (NRS)
  2. Pain Impact

    Time frame: From enrollment to the end of treatment at 8 weeks

    • Pain Disability Index (PDI)
  3. Mental Health

    Time frame: From enrollment to the end of treatment at 8 weeks

    Mental Health:

    • Depression Anxiety and Stress Scale (DASS-21)
  4. 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

  1. Mindful Awareness

    Time frame: From enrollment to the end of treatment at 8 weeks

    Mindful Awareness:

    • Mindful Attention Awareness Scale (MAAS)
  2. Emotional Regulation

    Time frame: From enrollment to the end of treatment at 8 weeks

    Emotional Regulation:

    • Difficulties in Emotion Regulation Scale - Short Form (DERS-SF)
  3. Psychological Flexibility

    Time frame: From enrollment to the end of treatment at 8 weeks

    Psychological Flexibility:

    • Comprehensive Assessment of Acceptance and Commitment Therapy Processes (CompACT)

Study contacts

Contact information is provided by the study sponsor or research team.

Sérgio A Carvalho, PhD

CONTACT

[email protected]

+351 239 851 450

Sponsors and collaborators

Lead sponsor

University of Coimbra

Other

Collaborators

  • Unidade Local de Saúde de Coimbra, EPE

Registry information

Official study 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

Acronym: VR-ACT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
May 25, 2025
Registry last updated
May 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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