Smartphone-based Mindfulness Training for Chronic Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test a smartphone-based mindfulness training program for chronic pain. Research participants use a 20 minute app-guided audio program six days per week. The study hypothesis is that training in this technique over a period of four weeks will reduce pain interference with daily life activities. This study does not require any travel or in-person contact with research staff-- all elements of the study are completed on the participant's smartphone.

Detailed Description
-----------------
This is a randomized, waitlist controlled trial. Smartphone users who download the research app complete an electronic informed consent before the app content is made available. Subjects meeting inclusion criteria are then prompted to complete baseline questionnaires. Submission of questionaires triggers randomization to one of two groups-- active treatment or waitlist. Subjects have equal chance of entering either group. The active treatment group is instructed to use the app-guided body scan exercise daily for six days per week. The waitlist group is instructed that the research intervention will be made available to them in four weeks time. On a weekly basis, all subjects complete a Brief Pain Inventory scale. At the end of four weeks, subjects again complete a Brief Pain Inventory as well as the questionnaires measuring secondary outcomes. Upon completion of the control condition, waitlist subjects are invited to begin using the body scan exercise as described above. From this point forward, subjects receive the same protocol as the active treatment group. This study involves no face-to-face contact between participants and study investigators/staff.

Official Title
-----------------
Smartphone-based Mindfulness Training for Chronic Pain: A Randomized Controlled Trial

Conditions
-----------------
Chronic Pain

Intervention / Treatment
-----------------
* Behavioral: Body scan exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Pain duration at least 3 months Access to smartphone Exclusion Criteria: Pain from active cancer Pain from active cardiac disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Waitlist<br>Participants randomized to this arm are instructed that they will have access to the study intervention after four weeks. Waitlist group participants are prompted to answer weekly questionnaires. | |
| Experimental: Active treatment<br>The active treatment group will be instructed to use the app-guided body scan exercise daily for six days per week over a period of four weeks. The body scan includes 20 minutes of guided audio-- the pre-recorded voice of a narrator instructs the user to systematically direct attention to various parts of the body. Before and after each use of the body scan, users complete a single-item scale measuring pain intensity/distress. Users are prompted to complete all other questionnaires at weekly or four-week intervals. The app includes access to a graphical display showing changes in average pain level. Subjects also have access to a section of frequently asked questions about the practice. | Behavioral: Body scan exercise<br>* The body scan includes 20 minutes of guided audio-- the pre-recorded voice of a narrator instructs the user to systematically direct attention to various parts of the body. The audio content is adapted from the body scan exercises traditionally taught in evidence-based mindfulness interventions.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain functional interference index | Change in pain functional interference index (part of Brief Pain Inventory questionnaire) during 4 week period | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic pain, Mobile applications, Mindfulness, Meditation, Telemedicine, Cellular phone, Pain Management, Therapy, computer-assisted