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Smartphone-based Mindfulness Training for Chronic Pain

Primary Purpose

Chronic Pain

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Body scan exercise
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Pain focused on measuring Chronic pain, Mobile applications, Mindfulness, Meditation, Telemedicine, Cellular phone, Pain Management, Therapy, computer-assisted

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • Pain from active cancer
  • Pain from active cardiac disease

Sites / Locations

  • University of California, San Francisco

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Waitlist

Active treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
January 13, 2014
Last Updated
October 23, 2014
Sponsor
University of California, San Francisco
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1. Study Identification

Unique Protocol Identification Number
NCT02037152
Brief Title
Smartphone-based Mindfulness Training for Chronic Pain
Official Title
Smartphone-based Mindfulness Training for Chronic Pain: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2014
Overall Recruitment Status
Withdrawn
Why Stopped
Problems with the software intervention, PI finished training and left UCSF.
Study Start Date
January 2014 (undefined)
Primary Completion Date
May 2014 (Anticipated)
Study Completion Date
May 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Pain
Keywords
Chronic pain, Mobile applications, Mindfulness, Meditation, Telemedicine, Cellular phone, Pain Management, Therapy, computer-assisted

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Arm Title
Active treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Body scan exercise
Intervention Description
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.
Primary Outcome Measure Information:
Title
Pain functional interference index
Description
Change in pain functional interference index (part of Brief Pain Inventory questionnaire) during 4 week period
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ida Sim, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94118
Country
United States

12. IPD Sharing Statement

Links:
URL
http://lettingpaingo.ucsf.edu
Description
Click here for more information about this study: Smartphone-based mindfulness training for chronic pain

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Smartphone-based Mindfulness Training for Chronic Pain

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