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Trial record 34 of 3544 for:    Louisville

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
Sponsor:
Information provided by (Responsible Party):
Gary C. Vitale, MD, University of Louisville

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
Chronic Pancreatitis Behavioral: Cognitive Behavioral Therapy Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 88 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.
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pancreatitis

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.



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Quality of Life [ Time Frame: 1 year ]
    quality of life with be measured using the SF-12® Patient Questionnaire

  2. Narcotic Usage [ Time Frame: 1 year ]
    Narcotic usage will be monitored at each follow-up.

  3. 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

  4. Hospitalizations [ Time Frame: 1 year ]
    Pre- and post- intervention hospitalizations will be recorded



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

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


Contacts
Contact: Gary C Vitale, MD (502) 629-2278 gcvita01@louisville.edu
Contact: Neal Bhutiani, MD (502) 629-6950 neal.bhutiani@louisville.edu

Locations
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact: Gary C Vitale, MD    502-629-2278    gcvita01@louisville.edu   
Contact: Amber N Brown, BA    502-216-3264    anbrow14@louisville.edu   
Principal Investigator: Gary C Vitale, MD         
Sub-Investigator: Joshua Tierney, MD         
Sponsors and Collaborators
University of Louisville

Publications:
Responsible Party: Gary C. Vitale, MD, General Surgeon, Professor of medicine, University of Louisville
ClinicalTrials.gov Identifier: NCT03112759     History of Changes
Other Study ID Numbers: 17.0352
First Posted: April 13, 2017    Key Record Dates
Last Update Posted: September 12, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
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:
Pancreatitis
Pancreatitis, Chronic
Pancreatic Diseases
Digestive System Diseases