Smartphone-based Mindfulness Training for Chronic Pain

NCT ID: NCT02037152

Last Updated: 2014-10-27

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2014-05-31

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.

Conditions

Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Waitlist

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Active treatment

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.

Group Type: EXPERIMENTAL

Body scan exercise

Intervention Type: BEHAVIORAL

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.

Interventions

Body scan exercise

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of California, San Francisco

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ida Sim, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

University of California, San Francisco

San Francisco, California, United States

Countries

United States

Other Identifiers

13-10820

Identifier Type: OTHER

Identifier Source: secondary_id

SBMT-CP-1

Identifier Type: -

Identifier Source: org_study_id