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

NCT06964360 | Recruiting

• 1 other identifier: 24/211-ACps
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 4

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.

Conditions

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

Keywords

Virtual Reality; Deprescribing; Primary Health Care; Psychoeducation; Non-Pharmacological Treatment; Emotional Regulation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change in emotional well-being measured using the 7-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-7)

  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.

  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.

  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)

  Baseline, immediately post-program (8-10 weeks)

Study Arms (2)

REDOCVR Psychoeducational Program

EXPERIMENTAL

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

Control - Standard Education

ACTIVE COMPARATOR

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

Interventions

REDOCVR Psychoeducational Program 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.

Also known as: Virtual Reality-Enhanced Group Intervention

REDOCVR Psychoeducational Program

Standard Educational Materials 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.

Also known as: Self-Directed Chronic Pain Education

Control - Standard Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Badalona Serveis Assistencials: lead

Study Sites (4)

Primary Care Progrès-Raval

Badalona, Barcelona, 08912, Spain

RECRUITING

Primary Care Center Apenins-Montigalà

Badalona, Barcelona, 08917, Spain

RECRUITING

Primary Care Center Morera-Pomar

Badalona, Barcelona, Spain

RECRUITING

CAP Montgat- Dr Jardi

Montgat, Barcelona, Spain

RECRUITING

Related Links

• Related Pilot Study on ClinicalTrials.gov

MeSH Terms

Conditions

Chronic Pain; Opioid-Related Disorders; Patient Participation; Emotional Regulation

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior; Self-Control; Social Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable - participants and providers are aware of group assignment due to the nature of the intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Researcher and Project Manager

Model Details: Two groups: REDOCVR intervention vs. standard education control

Study Record Dates

• First Submitted: May 1, 2025
• First Posted: May 9, 2025
• Study Start: May 6, 2024
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (4)