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

Primary Purpose

Chronic Pancreatitis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chronic Pancreatitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive Behavioral Therapy

No Cognitive Behavioral Therapy

Arm Description

Patients randomly selected for CBT will attend 8 weekly one-on-one therapy sessions. Patients will be prescribed conventional narcotic therapy as needed.

Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life
quality of life with be measured using the SF-12® Patient Questionnaire
Narcotic Usage
Narcotic usage will be monitored at each follow-up.
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
Hospitalizations
Pre- and post- intervention hospitalizations will be recorded

Full Information

First Posted
April 7, 2017
Last Updated
June 17, 2021
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03112759
Brief Title
Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
Official Title
Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
September 9, 2017 (Actual)
Primary Completion Date
March 26, 2020 (Actual)
Study Completion Date
March 26, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pancreatitis

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
9 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive Behavioral Therapy
Arm Type
Experimental
Arm Description
Patients randomly selected for CBT will attend 8 weekly one-on-one therapy sessions. Patients will be prescribed conventional narcotic therapy as needed.
Arm Title
No Cognitive Behavioral Therapy
Arm Type
No Intervention
Arm Description
Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Presence and severity of abdominal pain
Description
A visual analog scale will be used to measure patients pain pre- and post- intervention
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Quality of Life
Description
quality of life with be measured using the SF-12® Patient Questionnaire
Time Frame
1 year
Title
Narcotic Usage
Description
Narcotic usage will be monitored at each follow-up.
Time Frame
1 year
Title
Presence and Severity of Nausea and Reflux
Description
patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment
Time Frame
1 year
Title
Hospitalizations
Description
Pre- and post- intervention hospitalizations will be recorded
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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: 1. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23622135
Citation
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.
Results Reference
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PubMed Identifier
18506917
Citation
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.
Results Reference
background
PubMed Identifier
16937347
Citation
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.
Results Reference
background
PubMed Identifier
15020561
Citation
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.
Results Reference
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Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis

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