Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Pancreatitis
- Sponsor
- University of Louisville
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Presence and severity of abdominal pain
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.
Detailed Description
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. After 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.
Investigators
Gary C. Vitale, MD
General Surgeon, Professor of medicine
University of Louisville
Eligibility Criteria
Inclusion Criteria
- •Patient must be18 years of age
- •Diagnosed with chronic pancreatitis
- •Willing and able to comply with the protocol requirements
- •Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study
Exclusion Criteria
- •Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening
Outcomes
Primary Outcomes
Presence and severity of abdominal pain
Time Frame: 1 year
A visual analog scale will be used to measure patients pain pre- and post- intervention
Secondary Outcomes
- Quality of Life(1 year)
- Narcotic Usage(1 year)
- Presence and Severity of Nausea and Reflux(1 year)
- Hospitalizations(1 year)