Feasibility of a Mobile Electronic Mindfulness Therapy Service for Chronic Pancreatitis
Condition: Pancreatitis, Chronic
MeSH terms: Pancreatitis; Pancreatitis, Chronic
Study type: Observational

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 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.
    

Intervention name(s): Mobile Mindfulness Therapy
Intervention type(s): Behavioral
Intervention description(s): Subjects will be asked to complete 30 days of mobile mindfulness therapy, for 2-30 minutes daily.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        We will recruit a minimum of 10 and maximum of 40 subjects diagnosed with chronic
        pancreatitis and 5 healthy control subjects with no past or present chronic
        gastrointestinal symptoms lasting greater than 8 weeks, no chronic medical conditions and
        no organic gastrointestinal disease. All patients with suspected/definite chronic
        pancreatitis will be associated with Stanford Hospital and Clinics and the 5 healthy
        controls may or may not be associated with Stanford.