Chronic PancreatitisNCT03112759
Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
A study testing Cognitive Behavioral Therapy in people with Chronic Pancreatitis, run by University of Louisville at 1 site in United States.
Trial summary
This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pancreatitis
- What is being tested?
- Cognitive Behavioral Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2017to 26 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 1. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Louisville
Louisville, Kentucky, 40202
About this study
This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.
Read the 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.
- Conditions
- Chronic Pancreatitis
- Being tested
- Cognitive Behavioral Therapy
- Medical subject headings
- Pancreatitis, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral TherapyBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Cognitive Behavioral Therapy |
| No Cognitive Behavioral Therapy | No intervention | Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence and severity of abdominal pain
A visual analog scale will be used to measure patients pain pre- and post- intervention
Measured: 1 year
Secondary outcomes (4)
Quality of Life
quality of life with be measured using the SF-12® Patient Questionnaire
Measured: 1 year
Narcotic Usage
Narcotic usage will be monitored at each follow-up.
Measured: 1 year
Presence and Severity of Nausea and Reflux
patients will be queried about the presence and severity of nausea and reflux at each follow-up appointment
Measured: 1 year
Hospitalizations
Pre- and post- intervention hospitalizations will be recorded
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2017
- Study start9 Sep 2017
- Primary completion26 Mar 2020
- Study completion26 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies of the same condition, open and under way.
- More trials run by University of LouisvilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Louisville
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gary C. Vitale, MD, University of Louisville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03112759
- Sponsor's protocol ID
- 17.0352
- Status last verified
- Jun 2021
- First submitted
- 7 Apr 2017
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23622135Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. doi: 10.3748/wjg.14.3137.
PubMed 18506917Heapy 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.
PubMed 16937347Erdek 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.
PubMed 15020561
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Utility of Cognitive Behavioral Therapy for Pain Control in Patients With Chronic Pancreatitis
- ClinicalTrials.gov ID
- NCT03112759
- Acronym / sponsor ID
- 17.0352
- Conditions
- Chronic Pancreatitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- University of LouisvilleUniversity, hospital or other
- Study start
- 9 Sep 2017 (actual)
- Primary completion
- 26 Mar 2020 (actual)
- Study completion
- 26 Mar 2020 (actual)
- First posted
- 13 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will assess cognitive behavioral therapy as an adjunct to conventional symptom control for patients with chronic pancreatitis.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy | Experimental | Behavioral: Cognitive Behavioral TherapyPatients randomly selected for CBT will attend 8 weekly one-on-one therapy sessions. Patients will be prescribed conventional narcotic therapy as needed. |
| No Cognitive Behavioral Therapy | No intervention | –Patients randomly selected for no CBT will be treated with conventional narcotic therapy alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 1. Participating in another clinical trial for the treatment of chronic pancreatitis at the time of screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral TherapyCognitive 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 | Behavioural | Cognitive Behavioral Therapy |
Primary outcome
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
4 secondary outcomes
Quality of Life
Time frame: 1 year
Narcotic Usage
Time frame: 1 year
Presence and Severity of Nausea and Reflux
Time frame: 1 year
Hospitalizations
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Background: PubMed 23622135Yadav 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.
- Background: PubMed 18506917Gachago C, Draganov PV. Pain management in chronic pancreatitis. World J Gastroenterol. 2008 May 28;14(20):3137-48. doi: 10.3748/wjg.14.3137.
- Background: PubMed 16937347Heapy 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.
- Background: PubMed 15020561Erdek 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy in people with Chronic Pancreatitis, run by University of Louisville at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence and severity of abdominal pain (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03112759, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.