Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis

This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.

Study Overview

• Status: Completed
• Conditions: Chronic Pancreatitis
• Intervention / Treatment: Behavioral: Cognitive Behavioral Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Patient must be18 years of age
2. Diagnosed with chronic pancreatitis
3. Willing and able to comply with the protocol requirements
4. Able to comprehend and have signed the Informed Consent Form (ICF) to participate in the study

Exclusion Criteria:

1. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence and severity of abdominal pain	A visual analog scale will be used to measure patients pain pre- and post- intervention	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	quality of life with be measured using the SF-12® Patient Questionnaire	1 year
Narcotic Usage	Narcotic usage will be monitored at each follow-up.	1 year
Presence and Severity of Nausea and Reflux	patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment	1 year
Hospitalizations	Pre- and post- intervention hospitalizations will be recorded	1 year

Collaborators and Investigators

• Sponsor: University of Louisville

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2017
• Primary Completion (Actual): March 26, 2020
• Study Completion (Actual): March 26, 2020

Study Registration Dates

• First Submitted: April 7, 2017
• First Submitted That Met QC Criteria: April 7, 2017
• First Posted (Actual): April 13, 2017

Study Record Updates

• Last Update Posted (Actual): June 18, 2021
• Last Update Submitted That Met QC Criteria: June 17, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pancreatic Diseases; Pancreatitis; Pancreatitis, Chronic
• Other Study ID Numbers: 17.0352

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No