Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Completed

Conditions studied: Pancreatitis, Chronic

In brief

The research objective of this pilot study is to test the feasibility of a mobile electronic mindfulness therapy service for patients with definite or suspected chronic pancreatitis. A secondary aim will be to determine the effect of the intervention on a symptom severity/global assessment of improvement for patients with chronic pancreatitis. The investigators hypothesize that a one-month period of daily mindfulness therapy delivered via a phone messaging service will reduce symptoms.

Key facts

Study ID

NCT02224898

Run by

Stanford University

People needed

18

Starts

2014-08-01

Expected to finish

2015-10-01

Last updated by the study team

2015-11-17

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• For the study group: Patients with diagnosis of chronic pancreatitis with at least two of the following features: clinical course consistent with chronic pancreatitis, calcification in the pancreas on US/CT/EUS, ERCP showing ductal abnormalities (Cambridge Classification), exocrine insufficiency, histology showing irregular fibrosis, acinar cell loss, islet cell loss, and inflammatory cell infiltrates, or other features suggestive of chronic pancreatitis (such as pancreatic pseudocyst). The study group will also include patients with suspected chronic pancreatitis based on history of documented pancreatitis with lingering symptoms or signs of early chronic pancreatitis on imaging.
• For the control group: no history of chronic GI symptoms lasting greater than 8 weeks, no gastrointestinal disease or condition diagnosis, and not be currently experiencing gastrointestinal symptoms.
• Age 18 to 80
• Willing to give informed consent
• Able to complete entire study
• Ability to speak and read English
• Regular menstrual cycles or menopause for at least 6 months
• Owns a mobile phone with texting capabilities
• Unlimited minutes and text messaging dataplan for mobile phone
• Physically and mentally capable of using a mobile phone
• Phone access

You may not qualify if…

• Red flags of concern: anemia, blood in stools, unexplained weight loss, unexplained fevers
• Pregnant or nursing woman, or planning on becoming pregnant within next year
• Travel plans outside of the county over the study duration or a month prior
• Change in medications one month prior or during study
• Change in chronic pancreatitis management strategies one month prior or during study such as dietary changes, exercise, counseling and behavioral therapies.
• Current co-morbid condition that might account for GI symptoms
• Current infectious diseases: HIV, Hepatitis A, B or C, other
• Psychiatric Conditions: moderate to severe depression (ECT, unable to work, disrupts ADL's), moderate to severe anxiety (unable to work, disrupts ADL's), bipolar disorder, schizophrenia, or history of psychosis, suicidal ideation or attempt, substance abuse (alcohol and/or drugs in past year), dissociative disorder, dementia related disorder
• Immunologic Diseases: systemic lupus, moderate to severe arthritis, scleroderma, other
• Gastrointestinal Disorders: inflammatory bowel diseases (ulcerative colitis, Crohn's), celiac disease,personal history of colon cancer or polyps, other unless condition associated with chronic pancreatitis.
• Cardiovascular disorder, clinically significant in past 12 months
• Pain disorder, clinically significant (back pain, fibromyalgia)
• Recent surgery, during 6 months prior to study enrollment or during study period (except minor surgeries such as wisdom teeth extraction, cataract surgery, corrective lens surgery, and/or minor skin surgeries)
• Major stressor(s) in life 3 months prior to study or anticipated over the next month

Where it is running

• Stanford Hospital and Clinics — Palo Alto, California, United States

Full record on ClinicalTrials.gov

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