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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):

April 7, 2017
April 13, 2017
September 12, 2017
September 9, 2017
April 2018   (Final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT03112759 on ClinicalTrials.gov Archive Site
  • Quality of Life [ Time Frame: 1 year ]
    quality of life with be measured using the SF-12® Patient Questionnaire
  • Narcotic Usage [ Time Frame: 1 year ]
    Narcotic usage will be monitored at each follow-up.
  • 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
  • Hospitalizations [ Time Frame: 1 year ]
    Pre- and post- intervention hospitalizations will be recorded
Same as current
Not Provided
Not Provided
 
Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
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.

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.

Interventional
Not Provided
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
Chronic Pancreatitis
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
  • 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.
    Intervention: Behavioral: Cognitive Behavioral Therapy
  • No Intervention: No Cognitive Behavioral Therapy
    Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
88
July 2018
April 2018   (Final data collection date for primary outcome measure)

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

Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact: Gary C Vitale, MD (502) 629-2278 gcvita01@louisville.edu
Contact: Neal Bhutiani, MD (502) 629-6950 neal.bhutiani@louisville.edu
United States
 
 
NCT03112759
17.0352
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Gary C. Vitale, MD, University of Louisville
University of Louisville
Not Provided
Not Provided
University of Louisville
September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP