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Completed

NCT Number: NCT03112759

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening

Treatment and study plan

Cognitive behavioral therapy

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Apr 13, 2017
Registry last updated
Jun 18, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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