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

Not Applicable

Completed

• Conditions: Chronic Pancreatitis
• Interventions: Behavioral: Cognitive Behavioral Therapy

• Registration Number: NCT03112759
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2017-04-07
• Study First Submitted QC: 2017-04-07
• Study First Posted: 2017-04-13
• Study Start: 2017-09-09
• Primary Completion: 2020-03-26
• Study Completion: 2020-03-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cognitive Behavioral Therapy	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.

Primary Outcome Measures

Name	Time	Method
Presence and severity of abdominal pain	1 year	A visual analog scale will be used to measure patients pain pre- and post- intervention

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States