Ignite Creation Date:
2025-12-24 @ 3:05 PM
Ignite Modification Date:
2026-03-28 @ 5:24 AM
Study NCT ID:
NCT03112759
Status:
COMPLETED
Last Update Posted:
2021-06-18
First Post:
2017-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D050500', 'term': 'Pancreatitis, Chronic'}], 'ancestors': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients will be randomized into one of two arms: treatment with cognitive behavioral therapy and narcotics as needed or treatment with conventional narcotic analgesics alone. Patients undergoing CBT intervention will participate in eight weekly therapy sessions.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-09-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-06', 'completionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-06-17', 'studyFirstSubmitDate': '2017-04-07', 'studyFirstSubmitQcDate': '2017-04-07', 'lastUpdatePostDateStruct': {'date': '2021-06-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence and severity of abdominal pain', 'timeFrame': '1 year', 'description': 'A visual analog scale will be used to measure patients pain pre- and post- intervention'}], 'secondaryOutcomes': [{'measure': 'Quality of Life', 'timeFrame': '1 year', 'description': 'quality of life with be measured using the SF-12® Patient Questionnaire'}, {'measure': 'Narcotic Usage', 'timeFrame': '1 year', 'description': 'Narcotic usage will be monitored at each follow-up.'}, {'measure': 'Presence and Severity of Nausea and Reflux', 'timeFrame': '1 year', 'description': 'patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment'}, {'measure': 'Hospitalizations', 'timeFrame': '1 year', 'description': 'Pre- and post- intervention hospitalizations will be recorded'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '23622135', 'type': 'BACKGROUND', 'citation': 'Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.'}, {'pmid': '18506917', 'type': 'BACKGROUND', 'citation': 'Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. doi: 10.3748/wjg.14.3137.'}, {'pmid': '16937347', 'type': 'BACKGROUND', 'citation': 'Heapy AA, Stroud MW, Higgins DM, Sellinger JJ. Tailoring cognitive-behavioral therapy for chronic pain: a case example. J Clin Psychol. 2006 Nov;62(11):1345-54. doi: 10.1002/jclp.20314.'}, {'pmid': '15020561', 'type': 'BACKGROUND', 'citation': 'Erdek MA, Pronovost PJ. Improving assessment and treatment of pain in the critically ill. Int J Qual Health Care. 2004 Feb;16(1):59-64. doi: 10.1093/intqhc/mzh010.'}]}, 'descriptionModule': {'briefSummary': 'This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.', 'detailedDescription': 'All patients with chronic pancreatitis will be considered for participation in this study. Patients selected for participation will be evaluated 4 weeks prior to the first one-on-one therapy session. A baseline pain score will be assessed using the visual analog pain scale. Narcotic dosage and frequency as well as anti-emetic usage will be evaluated at this time. A pre-treatment quality of life score will be recorded using the SF-12® Patient Questionnaire. Patients will also be queried about the presence of nausea and reflux.\n\nAfter the pre-intervention evaluations are complete, patients will be randomized into one of two arms: treatment with cognitive behavioral therapy and narcotics as needed or treatment with conventional narcotic analgesics alone. Patients undergoing CBT intervention will participate in eight weekly therapy sessions. Follow-up assessments will be conducted six months and nine months after the last therapy session is completed. The patients will be evaluated based on pain score, narcotic dosage and frequency, anti-emetic usage, quality of life assessment, and pain related hospitalizations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patient must be18 years of age\n2. Diagnosed with chronic pancreatitis\n3. Willing and able to comply with the protocol requirements\n4. Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study\n\nExclusion Criteria:\n\n1\\. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening'}, 'identificationModule': {'nctId': 'NCT03112759', 'briefTitle': 'Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'University of Louisville'}, 'officialTitle': 'Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis', 'orgStudyIdInfo': {'id': '17.0352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavioral Therapy', 'description': 'Patients randomly selected for CBT will attend 8 weekly one-on-one therapy sessions. Patients will be prescribed conventional narcotic therapy as needed.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy']}, {'type': 'NO_INTERVENTION', 'label': 'No Cognitive Behavioral Therapy', 'description': 'Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone.'}], 'interventions': [{'name': 'Cognitive Behavioral Therapy', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral therapy (CBT) uses pain coping skills as a method of managing symptoms associated with chronic pain.Cognitive behavioral therapy teaches patients to identify and modify negative thoughts and behaviors that increase pain intensity, distress, and pain-related disability', 'armGroupLabels': ['Cognitive Behavioral Therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40202', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Louisville', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Louisville', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'General Surgeon, Professor of medicine', 'investigatorFullName': 'Gary C. Vitale, MD', 'investigatorAffiliation': 'University of Louisville'}}}}