Ignite Creation Date:
2025-12-26 @ 5:24 PM
Ignite Modification Date:
2025-12-26 @ 5:24 PM
Study NCT ID:
NCT06698406
Status:
RECRUITING
Last Update Posted:
2024-11-25
First Post:
2024-11-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Transcultural Validation of the French Version of the " Patients' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-21', 'studyFirstSubmitDate': '2024-11-18', 'studyFirstSubmitQcDate': '2024-11-18', 'lastUpdatePostDateStruct': {'date': '2024-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-11-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'incremental validity of the new ABDC scale', 'timeFrame': '1 day', 'description': 'Incremental validity is the degree to which a new scale increases the ability to predict an outcome beyond existing parameters and scales. In our case pain self-efficacy, measured by the "pain self-efficacy questionnaire" \\[8\\], which exists in a validated French version \\[9\\], is the outcome to be predicted.\n\nHierarchical regression analysis will have four models including in hierarchical order 8 explanatory variables: demographical variables (gender, age, level of education), depressive symptoms and anxiety, pain catastrophizing, pain acceptance, and finally the ABDC scale'}], 'secondaryOutcomes': [{'measure': 'Reliability of the ABDC scale', 'timeFrame': '1 day', 'description': "Reliability will be evaluated as internal consistency, measured by Cronbach's alpha and corrected item-total-correlations."}, {'measure': 'Convergent validity', 'timeFrame': '1 day', 'description': 'Convergent validity will be evaluated by the correlation between the ABDC scale sum score and the "Survey of Pain Attitudes SOPA" scale \\[10\\], a self-administered questionnaire with 57 statements evaluating 7 categories of beliefs and attitudes about pain.'}, {'measure': 'Discriminant validity', 'timeFrame': '1 day', 'description': "correlations with the following scales which measure constructs which are important determinants of chronic pain severity, but independent of the endorsement of the biopsychosocial model by a patient: Brief Pain Inventory (BPI) The Brief Pain Inventory (BPI) \\[11\\] is a tool used to assess pain in patients. It was developed to measure both the intensity of pain and its impact on the patient's daily life. We will evaluate correlations with both the BPI-pain severity and the BPI-pain interference subscores.\n\nGeneralized anxiety disorder questionnaire GAD-7 The GAD-7 \\[12\\] is a questionnaire used to assess generalized anxiety disorder. It consists of seven questions that evaluate different symptoms associated with anxiety, such as nervousness, restlessness, and difficulty controlling worry.\n\nDepressive symptoms: patient heath questionnaire PHQ-9 The PHQ-9 \\[13\\] is a screening tool for depression. It includes nine quest"}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pain, chronic', 'patient education', 'self efficacy', 'bio-psycho-social model'], 'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'We will validate the French version of the "Patients\' Endorsement of a Biopsychosocial model of chronic pain (PEB) scale" by comparing it to the "pain self-efficacy" questionnaire', 'detailedDescription': 'The primary objective is to validate the French version of the PEB scale, called "Echelle d\'Adhésion du modèle Bio-psycho-social par des patients avec Douleur Chronique ABDC".\n\nThe hypothesis is that the ABDC scale is a valid measurement tool to measure and operationalize beliefs about the biopsychosocial nature of pain in adults with chronic pain.\n\nConsenting patients will receive paper copies of the study questionnaire including the questionnaires named in the secondary outcomes section, except those which are already included in the standard evaluation questionnaire of the pain consultation (BPI, GAD-7, PHQ-9). Patients will return the questionnaire either at a the same or a follow-up consultation, or send in the questionnaire by post in a prepaid envelope.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "patients treated by the ambulatory chronic pain clinic (consultation d'antalgie) of the HUG", 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\- Patients with chronic pain (defined by ICD-11 as pain persisting or recurring longer than 3 months) having a chronic pain consultation at the HUG\n* French-speaking and able to understand the study information\n* ≥18 years of age\n\nExclusion Criteria:\n\n* \\- Inability to understand the consent form and the questionnaire, e.g. due to lan-guage problems, psychological disorders, dementia, etc. of the participant\n* Enrolment of the investigator, his/her family members, employees and other de-pendent persons'}, 'identificationModule': {'nctId': 'NCT06698406', 'briefTitle': 'Transcultural Validation of the French Version of the " Patients\' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Transcultural Validation of the French Version of the " Patients\' Endorsement of a Biopsychosocial Model of Chronic Pain " Scale', 'orgStudyIdInfo': {'id': 'ABDC validation'}}, 'contactsLocationsModule': {'locations': [{'zip': '1205', 'city': 'Geneva', 'status': 'RECRUITING', 'country': 'Switzerland', 'contacts': [{'name': 'Virginie Comte', 'role': 'CONTACT', 'email': 'virginie.comte@hug.ch', 'phone': '0795538452'}], 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Benno Rehberg-Klug', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical professor', 'investigatorFullName': 'Benno Rehberg-Klug', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}