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Chronic PainREDOCVR_ACNCT06964360

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

A study testing REDOCVR Psychoeducational Program and Standard Educational Materials in people with Chronic Pain and Central Sensitisation, run by Badalona Serveis Assistencials at 4 sites in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
REDOCVR Psychoeducational Program and Standard Educational Materials
Could I receive a placebo?
No, everyone receives an active treatment
How many people
174 participants
Where
4 sitesSpain
Study dates
6 May 2024to 22 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

4 sites in 1 country.

Spain4 sites

  • Primary Care Progrès-Raval

    Badalona, Barcelona, 08912

  • Primary Care Center Apenins-Montigalà

    Badalona, Barcelona, 08917

  • Primary Care Center Morera-Pomar

    Badalona, Barcelona

  • CAP Montgat- Dr Jardi

    Montgat, Barcelona

Other trials in Spain

About this study

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.

Read the 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.

Being tested
REDOCVR Psychoeducational Program, Standard Educational Materials
Keywords
Virtual Reality, Deprescribing, Primary Health Care, Psychoeducation, Non-Pharmacological Treatment, Emotional Regulation
Medical subject headings
Chronic Pain, Opioid-Related Disorders, Patient Participation, Emotional Regulation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REDOCVR Psychoeducational ProgramBehavioural

    Also called Virtual Reality-Enhanced Group Intervention

    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.

  • Standard Educational MaterialsBehavioural

    Also called Self-Directed Chronic Pain Education

    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.

Study groups in NCT06964360
Study groupRoleWhat they receive
REDOCVR Psychoeducational ProgramExperimentalParticipants 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.
Receives: Behavioral: REDOCVR Psychoeducational Program
Control - Standard EducationActive comparatorParticipants 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.
Receives: Behavioral: Standard Educational Materials

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline, immediately post-program (8 weeks), 3-month follow-up

Secondary outcomes (4)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2025
  2. Study start6 May 2024
  3. Primary completion22 May 2026
  4. Study completion22 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
Two groups: REDOCVR intervention vs. standard education control
Masking
None (open label)
Enrolment
174 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06964360
Sponsor's protocol ID
24/211-ACps
Acronym
REDOCVR_AC
Status last verified
May 2026
First submitted
1 May 2025
Last updated
28 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: 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.

Questions about this trial

What is this clinical trial studying?

A study testing REDOCVR Psychoeducational Program and Standard Educational Materials in people with Chronic Pain and Central Sensitisation, run by Badalona Serveis Assistencials at 4 sites in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in daily dose of chronic pain medications (time frame: Baseline, immediately post-program (8 weeks), 3-month follow-up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06964360.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2026.

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