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

NCT ID: NCT06964360

Last Updated: 2025-05-14

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-06
• Study Completion Date: 2026-03-31

Brief Summary

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.

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.

Conditions

Chronic Pain; Central Sensitisation; Opioid-Related Disorders; Patient Empowerment

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

REDOCVR Psychoeducational Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: ACTIVE_COMPARATOR

Standard Educational Materials

Intervention Type: BEHAVIORAL

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Virtual Reality-Enhanced Group Intervention; Self-Directed Chronic Pain Education

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Badalona Serveis Assistencials

OTHER

Sponsor Role: lead

Responsible Party

Jose Ferrer Costa

Medical Researcher and Project Manager

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Primary Care Progrès-Raval

Badalona, Barcelona, Spain

Site Status: RECRUITING

Primary Care Center Apenins-Montigalà

Badalona, Barcelona, Spain

Site Status: RECRUITING

Primary Care Center Morera-Pomar

Badalona, Barcelona, Spain

Site Status: RECRUITING

CAP Montgat- Dr Jardi

Montgat, Barcelona, Spain

Site Status: RECRUITING

Countries

Spain

Facility Contacts

Jose Ferrer Costa, MD

Role: primary

jfcosta@bsa.cat

0034933951779

Elena Villabona López, MSc

Role: backup

evlopez@bsa.cat

0034933890695

José Ferrer Costa, MD

Role: primary

jfcosta@bsa.cat

0034933951779

Christian Torrecillas Camacho, BSc

Role: backup

ctcamacho@bsa.cat

0034933951779

Nuria Moran Blanco, MD

Role: primary

nmoran15@bsa.cat

0034934655200

Laura Villares Urgell, MSc

Role: backup

lvurgell@bsa.cat

0034934655200

José Ferrer Costa, MD

Role: primary

jfcosta@bsa.cat

0034933951779

Paula Reventós Osuna

Role: backup

prosuna@bsa.cat

0034934694930

Related Links

https://clinicaltrials.gov/study/NCT06361706

Related Pilot Study on ClinicalTrials.gov

Other Identifiers

24/211-ACps

Identifier Type: -

Identifier Source: org_study_id