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

Badalona Serveis Assistencials

Status: Enrolling

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

Treatments: Behavioral: Standard Educational Materials; Behavioral: REDOCVR Psychoeducational Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06964360

24/211-ACps

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

72 participants in 2 patient groups

REDOCVR Psychoeducational Program

Experimental group

Description:

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.

Treatment:

Behavioral: REDOCVR Psychoeducational Program

Control - Standard Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Standard Educational Materials