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

University of Louisville (UOFL)

Status: Completed

Conditions: Chronic Pancreatitis

Treatments: Behavioral: Cognitive Behavioral Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT03112759

17.0352

Details and patient eligibility

About

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

Full 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.

Enrollment: 9 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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9 participants in 2 patient groups

Cognitive Behavioral Therapy

Experimental group

Description:

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

Treatment:

Behavioral: Cognitive Behavioral Therapy

No Cognitive Behavioral Therapy

No Intervention group

Description:

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