Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2025-12-25 @ 7:22 PM
Study NCT ID:
NCT06599632
Status:
COMPLETED
Last Update Posted:
2025-12-04
First Post:
2024-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Traumatic Spinal Cord Injury
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013119', 'term': 'Spinal Cord Injuries'}], 'ancestors': [{'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020196', 'term': 'Trauma, Nervous System'}, {'id': 'D014947', 'term': 'Wounds and Injuries'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A replicated multiple baselines single-case experimental design with three baseline phases. Baseline randomization into three tiers.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 6}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2025-10-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-03', 'studyFirstSubmitDate': '2024-09-13', 'studyFirstSubmitQcDate': '2024-09-13', 'lastUpdatePostDateStruct': {'date': '2025-12-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Value-based living', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on Engaged Living Scale. Scored on a scale from 0 to 10. Higher scores means greater levels of value-based living.'}, {'measure': 'Pain interference', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Three single items focused specifically on general activities, relations with other people, and sleep. Based on Brief Pain Inventory. All three are scored on a scale from 0 to 10. Higher scores means greater levels of pain interference.'}, {'measure': 'Value-based living', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Engaged Living Scale. 16 item scale. Scored on a scale from 1 to 5. Higher total scores indicate greater levels of value-based living.'}, {'measure': 'Pain interference', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Brief Pain Inventory. 7 item scale. Scored on a scale from 0 to 10. Higher total scores indicate greater pain interference.'}], 'secondaryOutcomes': [{'measure': 'Pain catastrophizing', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on Daily Pain Catastrophizing Scale). Scored on a scale from 0 to 10. Higher scores means greater levels of pain catastrophizing.'}, {'measure': 'Positive affect', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of positive affect.'}, {'measure': 'Negative affect', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of negative affect.'}, {'measure': 'Stress', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of stress.'}, {'measure': 'Fatigue', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on previous diary studies. Scored on a scale from 0 to 10. Higher scores means greater levels of fatigue.'}, {'measure': 'Pain-related acceptance', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on Chronic Pain Acceptance Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of acceptance.'}, {'measure': 'Pain-related self-efficacy', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on Pain Self-efficacy Questionnaire. Scored on a scale from 0 to 10. Higher scores means greater levels of self-efficacy'}, {'measure': 'Pain severity', 'timeFrame': 'Daily throughout baseline phase (1-3 weeks) and treatment phase (10 weeks).', 'description': 'Single item measure based on Brief Pain Inventory. Scored on a scale from 0 to 10. Higher scores means greater levels of pain severity.'}, {'measure': 'Pain Disability', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Pain Disability Index. 7 items scored on a scale from 0 to 10. Higher total scores indicate greater disability'}, {'measure': 'Depression', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Patient Health Questionnaire (PHQ-9). 9 item scale. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of depression.'}, {'measure': 'Anxiety', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Generalized Anxiety Disorder (GAD-7). 7 items. Scored on a scale from 0 to 3. Higher total scores indicate greater levels of anxiety.'}, {'measure': 'Stress', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Perceived Stress Scale. 10 items. Scored on a 5-point scale. Higher total scores indicate greater levels of stress.'}, {'measure': 'Health-related quality of life', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'EuroQoL-5D-5L. 5 items scored on a 5-point scale and one item scored on a 0 to 100 scale. Higher scores on the first 5 items indicate reduced quality of life and higher scores on the last item indicates greater quality of life.'}, {'measure': 'Pain-related acceptance', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Chronic Pain Acceptance Questionnaire (CPAQ-8). 8 items scored on a scale from 0 to 6. Higher total scores indicate greater levels of acceptance.'}, {'measure': 'Pain-related self-efficacy', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Pain Self-Efficacy Questionnaire. 2 items scored on a scale from 0 to 6. Higher scores indicate greater self-efficacy.'}, {'measure': 'Sleep quality', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Karolinska Sleep Questionnaire. 4 items scores on a scale from 0 to 5. Higher total scores indicates poorer quality of sleep.'}, {'measure': 'Pain severity', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Four 0-10 numeric rating scale (NRS) for worst, mildest, average, and current pain. Scored on a scale from 0 to 10. Higher scores indicate greater levels of pain severity'}, {'measure': 'Self-perceived improvement', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Global Rating of Change. 1 item scored on a scale from 1 to 15. Higher scores indicate greater level of self-perceived improvement.'}, {'measure': 'Satisfaction with treatment', 'timeFrame': 'Pre-treatment, post-treatment (i.e., within one week from the day of last treatment), 3 months follow-up after treatment completion', 'description': 'Self-developed NRS-item from 0 = not at all satisfied to 10 = completely satisfied.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Spinal Cord Injury (SCI)']}, 'referencesModule': {'references': [{'pmid': '41287070', 'type': 'DERIVED', 'citation': 'Aaby AO, Andersen TE, Ravn SL. Interdisciplinary value-based cognitive behavioral treatment for people with persistent pain after posttraumatic spinal cord injury (project VALIANT): protocol for an intervention study using multiple baselines single-case experimental design. BMC Psychol. 2025 Nov 24;13(1):1294. doi: 10.1186/s40359-025-03637-5.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to address the critical need for effective interventions by developing and testing an interdisciplinary values-based cognitive behavioral therapy (V-CBT) program for individuals with spinal cord injury. The main question it aims to answer are:\n\n* What is the treatment effect of the interdisciplinary values-based cognitive behavioral therapy (V-CBT) program on individuals with spinal cord injury?\n* What are the temporal relationships between primary and secondary outcome measures in the context of the V-CBT program?\n\nParticipants will undergo a replicated multiple baselines single-case experimental design (SCED). Nine participants who meet specific eligibility criteria will be block-randomized to a 1, 2, or 3-week baseline phase, serving as their own controls. The intervention involves an interdisciplinary team delivering a manualized adapted V-CBT program over ten sessions, focusing on psychological and physical rehabilitation. Participants will be required to attend these sessions either in person at Specialized Hospital for Polio and Accident Victims or virtually via secure videoconferencing as part of the treatment protocol. Data collection includes daily online self-reports and comprehensive measurements at pre-treatment, post- treatment, and a three-month follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be 18 years or older\n* speak and read Danish\n* aquired spinal cord injury\n* paraplegia or tetraplegia (either complete or incomplete)\n* daily pain\n* therapy-ready and motivated for this treatment type\n* willing to engage in homework\n* willing to respond to daily questionnaires\n* able to attend weekly sessions without payment\n\nExclusion Criteria:\n\n* any red flags during physiotherapeutic examination\n* acute or sub-acute stage\n* current pressure ulcers\n* known and unstable psychiatric disorder\n* syringomyelia\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT06599632', 'acronym': 'VALIANT', 'briefTitle': 'Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Traumatic Spinal Cord Injury', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'Interdisciplinary Value-based Cognitive Behavioral Treatment for People With Spinal Cord Injury After Road Traffic Accidents: Protocol for a Multiple Baselines Single-case Experimental Design.', 'orgStudyIdInfo': {'id': '2110041(SCI)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Baseline phase', 'description': 'There are three baseline phases of 1, 2, or 3 weeks to which participants are block-randomized followed by a 10-week intervention phase. Hence, participants are their own case-controls.', 'interventionNames': ['Behavioral: Values-based Cognitive Behavioral Therapy (V-CBT)']}], 'interventions': [{'name': 'Values-based Cognitive Behavioral Therapy (V-CBT)', 'type': 'BEHAVIORAL', 'description': 'The intervention offers a 10-session treatment for spinal cord injury (SCI). The manualized adapted version of value-based cognitive behavioral treatment (V-CBT) is conducted by interdisciplinary teams of psychologists and physiotherapists. The program, based on V-CBT principles, focuses on psychoeducation, fostering self-efficacy, and setting value-based goals in the initial three sessions. The subsequent seven sessions involve physiotherapists trained in V-CBT, addressing psychological, physical, social, and practical barriers hindering engagement in participants lives. Each session combines psychologically informed themes and supervised exercises, aiming to enhance engagement in values-based activities.', 'armGroupLabels': ['Baseline phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2610', 'city': 'Rødovre Municipality', 'country': 'Denmark', 'facility': 'Specialized Hospital for Polio and Accident Victims', 'geoPoint': {'lat': 55.68062, 'lon': 12.45373}}], 'overallOfficials': [{'name': 'Tonny E Andersen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}, {'name': 'Sophie L Ravn, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Southern Denmark'}, {'name': 'Anders O Aaby, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Guest researcher', 'investigatorFullName': 'Anders Orup Aaby', 'investigatorAffiliation': 'University of Southern Denmark'}}}}