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

Sponsor
University of Louisville (Other)
Overall Status
Completed
CT.gov ID
NCT03112759
Collaborator
(none)
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Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Behavioral Therapy
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
9 participants
Allocation:
Randomized
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.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 :
Sep 9, 2017
Actual Primary Completion Date :
Mar 26, 2020
Actual Study Completion Date :
Mar 26, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Quality of Life [1 year]

    quality of life with be measured using the SF-12® Patient Questionnaire

  2. Narcotic Usage [1 year]

    Narcotic usage will be monitored at each follow-up.

  3. 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

  4. Hospitalizations [1 year]

    Pre- and post- intervention hospitalizations will be recorded

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Louisville Louisville Kentucky United States 40202

Sponsors and Collaborators

  • University of Louisville

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Gary C. Vitale, MD, General Surgeon, Professor of medicine, University of Louisville
ClinicalTrials.gov Identifier:
NCT03112759
Other Study ID Numbers:
  • 17.0352
First Posted:
Apr 13, 2017
Last Update Posted:
Jun 18, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 18, 2021