Clinical trial NCT06964360: Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization
Official title: Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Chronic Pain
Central Sensitisation
Opioid-Related Disorders
Patient Empowerment
Keywords: Virtual Reality
Deprescribing
Primary Health Care
Psychoeducation
Non-Pharmacological Treatment
Emotional Regulation
Lead sponsor: Badalona Serveis Assistencials
Sponsor class: OTHER
First posted: 2025-05-09
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups: REDOCVR intervention vs. standard education control
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change in daily dose of chronic pain medications
timeFrame: Baseline, immediately post-program (8 weeks), 3-month follow-up
Secondary outcomes:
measure: Change in emotional well-being measured using the 7-item Warwick-Edinburgh Mental Wellbeing Scale (WEMWBS-7)
timeFrame: Baseline, immediately post-program (8-10 weeks)
measure: Change in anxiety and depression levels measured using the Hospital Anxiety and Depression Scale (HADS), assessing both anxiety and depression subscales.
timeFrame: Baseline, immediately post-program (8-10 weeks)
measure: Change in central sensitization symptoms measured using the Central Sensitization Inventory (CSI), a self-report tool for sensitization-related symptoms.
timeFrame: Baseline, immediately post-program (8-10 weeks)
measure: Change in health-related quality of life measured using the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)
timeFrame: Baseline, immediately post-program (8-10 weeks)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Primary Care Progrès-Raval
state: Barcelona
city: Badalona
country: Spain
facility: Primary Care Center Apenins-Montigalà
state: Barcelona
city: Badalona
country: Spain
facility: Primary Care Center Morera-Pomar
state: Barcelona
city: Montgat
country: Spain
facility: CAP Montgat- Dr Jardi
state: Barcelona
Study officials:
References: