Smartphone-based Mindfulness Training for Chronic Pain

Chronic Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02037152
• Other study ID #: SBMT-CP-1
• Secondary ID: 13-10820
• Status: Withdrawn
• Phase: N/A
• First received: January 13, 2014
• Last updated: October 23, 2014
• Start date: January 2014
• Est. completion date: May 2014

Study information

• Verified date: October 2014
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2014
• Est. primary completion date: May 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English speaking

• Pain duration at least 3 months

• Access to smartphone

Exclusion Criteria:

• Pain from active cancer

• Pain from active cardiac disease

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Pain

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain functional interference index	Change in pain functional interference index (part of Brief Pain Inventory questionnaire) during 4 week period	4 weeks	No

External Links

•   Click here for more information about this study: Smartphone-based mindfulness training for chronic pain