Ignite Creation Date:
2025-12-25 @ 2:09 AM
Ignite Modification Date:
2026-03-06 @ 7:20 AM
Study NCT ID:
NCT06964360
Status:
RECRUITING
Last Update Posted:
2025-05-14
First Post:
2025-05-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D009293', 'term': 'Opioid-Related Disorders'}, {'id': 'D010358', 'term': 'Patient Participation'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000079524', 'term': 'Narcotic-Related Disorders'}, {'id': 'D019966', 'term': 'Substance-Related Disorders'}, {'id': 'D064419', 'term': 'Chemically-Induced Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not applicable - participants and providers are aware of group assignment due to the nature of the intervention.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Two groups: REDOCVR intervention vs. standard education control'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 72}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-05-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-09', 'studyFirstSubmitDate': '2025-05-01', 'studyFirstSubmitQcDate': '2025-05-01', 'lastUpdatePostDateStruct': {'date': '2025-05-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in daily dose of chronic pain medications', 'timeFrame': 'Baseline, immediately post-program (8 weeks), 3-month follow-up', 'description': 'Reduction in total daily dosage of prescribed medications used for chronic pain (e.g., opioids, benzodiazepines, NSAIDs), converted into standardized dose equivalents.'}], 'secondaryOutcomes': [{'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)', 'description': 'A 7-item self-report scale assessing positive mental health, including aspects of optimism, relaxation, and interpersonal relationships.\n\nScale Range: 7 to 35 Interpretation: Higher scores indicate better emotional well-being.'}, {'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)', 'description': 'A 14-item self-assessment scale with two subscales: HADS-Anxiety (HADS-A) and HADS-Depression (HADS-D), each containing 7 items.\n\nScale Range: 0 to 21 per subscale\n\nInterpretation:\n\n0-7: Normal 8-10: Borderline abnormal 11-21: Abnormal Higher scores indicate greater levels of anxiety or depression.'}, {'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)', 'description': 'A 25-item self-report questionnaire assessing symptoms related to central sensitization (e.g., widespread pain, sleep disturbance, fatigue).\n\nScale Range: 0 to 100 Interpretation: Higher scores indicate more severe symptoms of central sensitization.\n\nScores ≥ 40 suggest clinically relevant central sensitization.'}, {'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)', 'description': '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.\n\nTwo evaluation methods will be used:\n\nA validated utility index score, derived using a country-specific value set, ranging from less than 0 (worse than death) to 1 (full health).\n\nA 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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Virtual Reality', 'Deprescribing', 'Primary Health Care', 'Psychoeducation', 'Non-Pharmacological Treatment', 'Emotional Regulation'], 'conditions': ['Chronic Pain', 'Central Sensitisation', 'Opioid-Related Disorders', 'Patient Empowerment']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://clinicaltrials.gov/study/NCT06361706', 'label': 'Related Pilot Study on ClinicalTrials.gov'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nParticipants 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults (≥18 years) diagnosed with chronic non-cancer pain persisting for at least 3 months\n* Assigned to one of the participating primary care centers\n* Presence of central sensitization symptoms, emotional distress, kinesophobia, or inadequate response to prior treatments\n* Capacity to provide informed consent and complete questionnaires\n\nExclusion Criteria:\n\n* Acute pain conditions (duration \\<3 months)\n* Severe psychiatric or cognitive impairment\n* Uncontrolled vertigo, epilepsy, or major visual/auditory impairments\n* Conditions contraindicating use of VR equipment\n* Inability to attend scheduled sessions'}, 'identificationModule': {'nctId': 'NCT06964360', 'acronym': 'REDOCVR_AC', 'briefTitle': 'Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization', 'organization': {'class': 'OTHER', 'fullName': 'Badalona Serveis Assistencials'}, 'officialTitle': 'Clinical Trial on Deprescribing Associated With a Psychoeducational Program Using Virtual Reality for Patients With Chronic Pain and Central Sensitization', 'orgStudyIdInfo': {'id': '24/211-ACps'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'REDOCVR Psychoeducational Program', '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.', 'interventionNames': ['Behavioral: REDOCVR Psychoeducational Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control - Standard Education', '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.', 'interventionNames': ['Behavioral: Standard Educational Materials']}], 'interventions': [{'name': 'REDOCVR Psychoeducational Program', 'type': 'BEHAVIORAL', 'otherNames': ['Virtual Reality-Enhanced Group Intervention'], 'description': '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.', 'armGroupLabels': ['REDOCVR Psychoeducational Program']}, {'name': 'Standard Educational Materials', 'type': 'BEHAVIORAL', 'otherNames': ['Self-Directed Chronic Pain Education'], 'description': '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.', 'armGroupLabels': ['Control - Standard Education']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08912', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jose Ferrer Costa, MD', 'role': 'CONTACT', 'email': 'jfcosta@bsa.cat', 'phone': '0034933951779'}, {'name': 'Elena Villabona López, MSc', 'role': 'CONTACT', 'email': 'evlopez@bsa.cat', 'phone': '0034933890695'}, {'name': 'Elena Villabona Lopez, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jose Ferrer Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Melanie Rodriguez Belloso, BSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Primary Care Progrès-Raval', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'zip': '08917', 'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Ferrer Costa, MD', 'role': 'CONTACT', 'email': 'jfcosta@bsa.cat', 'phone': '0034933951779'}, {'name': 'Christian Torrecillas Camacho, BSc', 'role': 'CONTACT', 'email': 'ctcamacho@bsa.cat', 'phone': '0034933951779'}, {'name': 'José Ferrer Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Christian Torrecillas Camacho, BSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Alexandra Fernandez Brusco, BSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Primary Care Center Apenins-Montigalà', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Badalona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Nuria Moran Blanco, MD', 'role': 'CONTACT', 'email': 'nmoran15@bsa.cat', 'phone': '0034934655200'}, {'name': 'Laura Villares Urgell, MSc', 'role': 'CONTACT', 'email': 'lvurgell@bsa.cat', 'phone': '0034934655200'}, {'name': 'Jose Ferrer Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nuria Moran Blanco, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Laura Villare Urgel, MSc', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Pablo Serrano Ballena, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Primary Care Center Morera-Pomar', 'geoPoint': {'lat': 41.45004, 'lon': 2.24741}}, {'city': 'Montgat', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'José Ferrer Costa, MD', 'role': 'CONTACT', 'email': 'jfcosta@bsa.cat', 'phone': '0034933951779'}, {'name': 'Paula Reventós Osuna', 'role': 'CONTACT', 'email': 'prosuna@bsa.cat', 'phone': '0034934694930'}, {'name': 'José Ferrer Costa, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Paula Reventós Osuna', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Cristina Jaime Baena', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'CAP Montgat- Dr Jardi', 'geoPoint': {'lat': 41.46859, 'lon': 2.28001}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': '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.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Badalona Serveis Assistencials', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Researcher and Project Manager', 'investigatorFullName': 'Jose Ferrer Costa', 'investigatorAffiliation': 'Badalona Serveis Assistencials'}}}}