University of Louisville
Louisville, Kentucky, 40202, United States
NCT Number: NCT03112759
This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Louisville, Kentucky, 40202, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Time frame: 1 year
A visual analog scale will be used to measure patients pain pre- and post- intervention
Time frame: 1 year
quality of life with be measured using the SF-12® Patient Questionnaire
Time frame: 1 year
Narcotic usage will be monitored at each follow-up.
Time frame: 1 year
patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment
Time frame: 1 year
Pre- and post- intervention hospitalizations will be recorded
University of Louisville
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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