Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis

Pancreatitis, Chronic Clinical Trial

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

Status Completed

Clinical Trial 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.

Clinical Trial Description

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 and current location such as home or work. The investigators will track the mindfulness sessions the individual patient participated in by obtaining their recorded voice messages in an inbox that correlates with the duration of the mindfulness session that the patient participated in. The voice messaging system will also provide information of the time the voice message was left, or time of completion of the patient's mindfulness session. If the patient prematurely terminated his/her session, got disconnected from his/her session or forgot to leave a message, the patient may call the same provided phone number to leave a message with his/her name, date of unrecorded session along with its duration and location of participation such as home or work.

At the end of the study at four weeks, patients will be asked to complete an exit interview. The patient will be asked to fill out questionnaires during this interview. The patient will also be asked to participate in an informal exit interview with one of the research team members. Patients will be asked of any new medications were added during the duration of the study. They will also be asked regarding any changes in chronic pancreatitis strategies and any new stressors. ;

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pancreatitis
• Pancreatitis, Chronic

• NCT number: NCT02224898
• Study type: Observational
• Source: Stanford University
• Status: Completed
• Phase: N/A
• Start date: August 2014
• Completion date: October 2015