Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
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|ClinicalTrials.gov Identifier: NCT03112759|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : September 12, 2017
|Condition or disease||Intervention/treatment||Phase|
|Chronic Pancreatitis||Behavioral: Cognitive Behavioral Therapy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||88 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||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.|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis|
|Actual Study Start Date :||September 9, 2017|
|Estimated Primary Completion Date :||April 2018|
|Estimated Study Completion Date :||July 2018|
Experimental: Cognitive Behavioral Therapy
Patients randomly selected for CBT will attend 8 weekly one-on-one therapy sessions. Patients will be prescribed conventional narcotic therapy as needed.
Behavioral: Cognitive Behavioral Therapy
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
No Intervention: No Cognitive Behavioral Therapy
Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone.
- 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
- Quality of Life [ Time Frame: 1 year ]quality of life with be measured using the SF-12® Patient Questionnaire
- Narcotic Usage [ Time Frame: 1 year ]Narcotic usage will be monitored at each follow-up.
- Presence and Severity of Nausea and Reflux [ Time Frame: 1 year ]patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment
- Hospitalizations [ Time Frame: 1 year ]Pre- and post- intervention hospitalizations will be recorded
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03112759
|Contact: Gary C Vitale, MD||(502) firstname.lastname@example.org|
|Contact: Neal Bhutiani, MD||(502) email@example.com|
|United States, Kentucky|
|University of Louisville||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Gary C Vitale, MD 502-629-2278 firstname.lastname@example.org|
|Contact: Amber N Brown, BA 502-216-3264 email@example.com|
|Principal Investigator: Gary C Vitale, MD|
|Sub-Investigator: Joshua Tierney, MD|