NCT03112759

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 7, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 13, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 9, 2017

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 26, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2020

Completed
Last Updated

June 18, 2021

Status Verified

June 1, 2021

Enrollment Period

2.5 years

First QC Date

April 7, 2017

Last Update Submit

June 17, 2021

Conditions

Chronic Pancreatitis

Outcome Measures

Primary Outcomes (1)

  • Presence and severity of abdominal pain

    A visual analog scale will be used to measure patients pain pre- and post- intervention

    1 year

Secondary Outcomes (4)

  • Quality of Life

    1 year

  • Narcotic Usage

    1 year

  • Presence and Severity of Nausea and Reflux

    1 year

  • Hospitalizations

    1 year

Study Arms (2)

Cognitive Behavioral Therapy

EXPERIMENTAL

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

No Cognitive Behavioral Therapy

NO INTERVENTION

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

Interventions

Cognitive Behavioral TherapyBEHAVIORAL

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

Cognitive Behavioral Therapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Related Publications (4)

  • Yadav D, Lowenfels AB. The epidemiology of pancreatitis and pancreatic cancer. Gastroenterology. 2013 Jun;144(6):1252-61. doi: 10.1053/j.gastro.2013.01.068.

    PMID: 23622135BACKGROUND

  • Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. doi: 10.3748/wjg.14.3137.

    PMID: 18506917BACKGROUND

  • Heapy AA, Stroud MW, Higgins DM, Sellinger JJ. Tailoring cognitive-behavioral therapy for chronic pain: a case example. J Clin Psychol. 2006 Nov;62(11):1345-54. doi: 10.1002/jclp.20314.

    PMID: 16937347BACKGROUND

  • Erdek MA, Pronovost PJ. Improving assessment and treatment of pain in the critically ill. Int J Qual Health Care. 2004 Feb;16(1):59-64. doi: 10.1093/intqhc/mzh010.

    PMID: 15020561BACKGROUND

MeSH Terms

Conditions

Pancreatitis, Chronic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

PancreatitisPancreatic DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgeon, Professor of medicine

Study Record Dates

First Submitted

April 7, 2017

First Posted

April 13, 2017

Study Start

September 9, 2017

Primary Completion

March 26, 2020

Study Completion

March 26, 2020

Last Updated

June 18, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)