Clinical Trial: Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Brief Summary:

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.


Detailed Summary:

Patients who meet diagnostic criteria for definite or suspected chronic pancreatitis and have current symptoms over the past month will be considered for study enrollment. Potential patients will be initially pre-screened by a patient chart review.

If not excluded during the pre-screening process, potential subjects will be mailed questionnaires to fill out at home and speak with a member of the research team for an intake interview. At that time, they will be asked to sign a consent form after its review. Subjects will then be given instructions on how to participate in daily mindfulness therapy for one-month via the phone messaging service with a research team member.

The total duration of the study intervention will be four weeks where enrolled patients will be asked to perform daily mindfulness sessions through our electronic mobile mindfulness therapy service.

Patients will be sent a daily automated text message or call reminder to their mobile phone at a pre-determined time, selected by the patient at the intake interview. The text message will prompt patients with a phone number to call to access the Mindfulness Therapy sessions.

When the patient is ready, s/he will call the provided phone number which is an automated answering and voice messaging service, which will prompt the patient to select a mindfulness therapy session of varying durations from 2 to 30 minutes. The session will lead the patients through deep relaxation breathing exercise for the duration the patient selected from the phone menu. Although the investigators will only ask patients to do one mindfulness session a day, patients are free to do as many as they want a day. At the end of their session, patients will leave a voice message with their name
Sponsor: Stanford University

Current Primary Outcome: Feasibility of a Mobile Mindfulness Therapy Application for Chronic Pancreatitis [ Time Frame: 1 month ]

The primary outcome will measure daily compliance rates with the denominator being 30 days and the numerator equal to the number of days out of 30 that the patient used the mobile mindfulness therapy application.


Original Primary Outcome: Same as current

Current Secondary Outcome: The effect of mobile mindfulness therapy on a symptom severity/global assessment of improvement for patients with definite or suspected chronic pancreatitis [ Time Frame: 1 month ]

After consent to participate, the patient will complete a set of quality of life instruments before participating in the mindfulness therapy sessions. After 30 days, the patient will repeat completing the set of quality of life instruments. These include the SF-36, PANQOLI, and specific PROMIS QoL instruments.


Original Secondary Outcome: Same as current

Information By: Stanford University

Dates:
Date Received: August 20, 2014
Date Started: August 2014
Date Completion:
Last Updated: November 16, 2015
Last Verified: November 2015