Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization (REDOCVR_AC)

This clinical trial evaluates the effectiveness of the REDOCVR program, an interdisciplinary, psychoeducational intervention designed to support deprescribing of chronic pain medications in primary care. REDOCVR integrates group-based education, physical activation, and emotional regulation techniques, enhanced by immersive virtual reality (VR) content that reinforces therapeutic learning and engagement. Rather than functioning as a standalone tool, VR serves as a complementary catalyst within a person-centered, clinician-guided framework. This randomized trial adds a structured medication tapering component and runs in parallel with a complementary pilot study (ClinicalTrials.gov Identifier: NCT06361706), which evaluates the base REDOCVR program without supervised deprescribing. Both protocols are active and jointly contribute to an adaptive, scalable model of chronic pain care in primary care settings. Outcomes include medication use, emotional well-being, anxiety and depression, quality of life, and usability of VR.

Study Overview

• Status: Completed
• Conditions: Chronic Pain; Opioid-Related Disorders; Patient Empowerment; Central Sensitisation
• Intervention / Treatment: Behavioral: REDOCVR Psychoeducational Program; Behavioral: Standard Educational Materials

Detailed Description

This study is part of the broader REDOCVR initiative, a scalable chronic pain management program developed and implemented across primary care centers within Badalona Serveis Assistencials (BSA) in Catalonia, Spain. The REDOCVR program was designed in response to the increasing need for non-pharmacological interventions for chronic pain and integrates psychoeducation, physical activation, and emotional regulation techniques. Immersive virtual reality (VR) is incorporated not as a standalone treatment, but as an enhancing tool to increase engagement, support therapeutic learning, and promote self-management.

This randomized controlled trial represents a complementary arm of the REDOCVR implementation strategy. While the original pilot study (ClinicalTrials.gov Identifier: NCT06361706) focuses on feasibility, usability, and acceptability of the base REDOCVR intervention, the current protocol (24/211-ACps) adds a structured, physician-supervised medication tapering component for patients on chronic pain pharmacotherapy. Both protocols are active and interrelated, reflecting a modular, adaptive implementation model across different primary care sites.

Participants are adults with chronic non-cancer pain, referred during routine clinical visits and screened according to standardized eligibility criteria. The intervention group receives the full REDOCVR program, including immersive VR and deprescribing support, while the control group receives standard educational materials and usual care. Primary and secondary outcomes include change in medication use, emotional well-being (WEMWBS-7), anxiety and depression (HADS), central sensitization (CSI), health-related quality of life (EQ-5D-5L), and usability and satisfaction with the VR platform. Data collection occurs at baseline, post-intervention, and follow-up.

The study follows a hybrid type-2 implementation-effectiveness design and is aligned with ethical and regulatory standards, including approval from the CEIm IDIAPJGol. Findings will contribute to the growing evidence base for interdisciplinary, technology-enhanced models of chronic pain care in real-world primary care settings.

• Study Type: Interventional
• Enrollment (Actual): 174
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Barcelona
    • Badalona, Barcelona, Spain, 08912
      • Primary Care Progrès-Raval
    • Badalona, Barcelona, Spain, 08917
      • Primary Care Center Apenins-Montigalà
    • Badalona, Barcelona, Spain
      • Primary Care Center Morera-Pomar
    • Montgat, Barcelona, Spain
      • CAP Montgat- Dr Jardi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults (≥18 years) diagnosed with chronic non-cancer pain persisting for at least 3 months
• Assigned to one of the participating primary care centers
• Presence of central sensitization symptoms, emotional distress, kinesophobia, or inadequate response to prior treatments
• Capacity to provide informed consent and complete questionnaires

Exclusion Criteria:

• Acute pain conditions (duration <3 months)
• Severe psychiatric or cognitive impairment
• Uncontrolled vertigo, epilepsy, or major visual/auditory impairments
• Conditions contraindicating use of VR equipment
• Inability to attend scheduled sessions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control - Standard Education; Participants receive standard written and audiovisual educational materials related to chronic pain self-management. No virtual reality or group intervention is provided. Participants continue with usual care and may receive general support from their primary care physician, but without structured deprescribing guidance.	Behavioral: Standard Educational Materials; Participants receive written and audiovisual materials on chronic pain self-management. Materials are used independently without group sessions or virtual reality. No structured tapering support is provided beyond usual care.; Other Names: Self-Directed Chronic Pain Education
Experimental: REDOCVR Psychoeducational Program; Participants receive the full REDOCVR program, a group-based psychoeducational intervention enhanced with immersive virtual reality (VR). The program includes education on pain neuroscience, emotional regulation techniques, physical activation exercises, and VR-based experiential modules. Family physicians provide structured support for supervised tapering of chronic pain medications. The intervention is delivered over 8 weekly sessions of 90 minutes.	Behavioral: REDOCVR Psychoeducational Program; A clinician-guided, group-based psychoeducational program combining pain neuroscience education, emotional regulation techniques, physical activation, and immersive virtual reality experiences. Delivered in eight weekly 90-minute sessions. Includes structured medication tapering support provided by primary care physicians.; Other Names: Virtual Reality-Enhanced Group Intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in daily dose of chronic pain medications	Reduction in total daily dosage of prescribed medications used for chronic pain (e.g., opioids, benzodiazepines, NSAIDs), converted into standardized dose equivalents.	Baseline, immediately post-program (8 weeks), 3-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in emotional well-being measured using the 7-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-7)	A 7-item self-report scale assessing positive mental health, including aspects of optimism, relaxation, and interpersonal relationships. Scale Range: 7 to 35 Interpretation: Higher scores indicate better emotional well-being.	Baseline, immediately post-program (8-10 weeks)
Change in anxiety and depression levels measured using the Hospital Anxiety and Depression Scale (HADS), assessing both anxiety and depression subscales.	A 14-item self-assessment scale with two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each containing 7 items. Scale Range: 0 to 21 per subscale Interpretation: 0-7: Normal 8-10: Borderline abnormal 11-21: Abnormal Higher scores indicate greater levels of anxiety or depression.	Baseline, immediately post-program (8-10 weeks)
Change in central sensitization symptoms measured using the Central Sensitization Inventory (CSI), a self-report tool for sensitization-related symptoms.	A 25-item self-report questionnaire assessing symptoms related to central sensitization (e.g., widespread pain, sleep disturbance, fatigue). Scale Range: 0 to 100 Interpretation: Higher scores indicate more severe symptoms of central sensitization. Scores ≥ 40 suggest clinically relevant central sensitization.	Baseline, immediately post-program (8-10 weeks)
Change in health-related quality of life measured using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)	Each of the five dimensions (mobility, self-care, usual activities, pain/discomfort, anxiety/depression) is rated on a 5-point scale (1 = no problems to 5 = extreme problems), describing 3,125 possible health states. Two evaluation methods will be used: A validated utility index score, derived using a country-specific value set, ranging from less than 0 (worse than death) to 1 (full health). A raw sum score of the five dimension levels (range: 5 to 25) will be used for exploratory pre-post comparisons, with acknowledgment that this method is non-validated and should be interpreted cautiously.	Baseline, immediately post-program (8-10 weeks)

Collaborators and Investigators

• Sponsor: Badalona Serveis Assistencials

Publications and helpful links

Helpful Links

• Related Pilot Study on ClinicalTrials.gov

Study record dates

Study Major Dates

• Study Start (Actual): May 6, 2024
• Primary Completion (Actual): May 22, 2026
• Study Completion (Actual): May 22, 2026

Study Registration Dates

• First Submitted: May 1, 2025
• First Submitted That Met QC Criteria: May 1, 2025
• First Posted (Actual): May 9, 2025

Study Record Updates

• Last Update Posted (Actual): May 28, 2026
• Last Update Submitted That Met QC Criteria: May 24, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Primary Health Care; Virtual Reality; Psychoeducation; Deprescribing; Emotional Regulation; Non-Pharmacological Treatment
• Additional Relevant MeSH Terms: Narcotic-Related Disorders; Pain; Neurologic Manifestations; Mental Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Pathological Conditions, Signs and Symptoms; Behavior; Signs and Symptoms; Treatment Adherence and Compliance; Health Behavior; Patient Acceptance of Health Care; Social Behavior; Self-Control; Opioid-Related Disorders; Chronic Pain; Patient Participation; Emotional Regulation
• Other Study ID Numbers: 24/211-ACps

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) that underlie the results reported in this trial will be made available upon reasonable request. This includes anonymized data related to medication use, questionnaire responses, and outcome measures. Data will be shared for research purposes, subject to approval by the study investigators and in compliance with EU GDPR and local data protection regulations. Requests should be directed to the corresponding investigator at Badalona Serveis Assistencials.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No