Smartphone-based Mindfulness Training for Chronic Pain

Not Applicable

Withdrawn

• Conditions: Chronic Pain
• Interventions: Behavioral: Body scan exercise

• Registration Number: NCT02037152
• Lead Sponsor: University of California, San Francisco

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.

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-01-13
• Study First Submitted QC: 2014-01-13
• Study First Posted: 2014-01-15
• Primary Completion: 2014-05
• Study Completion: 2014-05
• Status Verified: 2014-10
• Last Update Submitted: 2014-10-23
• Last Update Posted: 2014-10-27

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• English speaking
• Pain duration at least 3 months
• Access to smartphone

Read More

Exclusion Criteria

• Pain from active cancer
• Pain from active cardiac disease

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active treatment	Body scan exercise	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.

Primary Outcome Measures

Name	Time	Method
Pain functional interference index	4 weeks	Change in pain functional interference index (part of Brief Pain Inventory questionnaire) during 4 week period

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States