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SCI Pain App Intervention Study

Primary Purpose

Spinal Cord Injuries, Chronic Pain

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Mindfulness Meditation App
Engagement and Distraction App
Sponsored by
Baylor College of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Spinal Cord Injuries

Eligibility Criteria

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

Inclusion Criteria:

  1. are at least 18 years of age
  2. have a traumatic SCI of at least 6 months duration
  3. have chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale]
  4. understand spoken and written English sufficiently to understand the goals, procedures, time involved, and the time involved in participation, participate in the intervention and complete study surveys.

Exclusion Criteria:

  1. have a significant visual or hearing impairment that limits their ability to participate in the app/computer-based intervention
  2. lack access to and the ability to use a smart phone or smart tablet (e.g., iPad)
  3. are unable to provide or obtain an email address for communication
  4. practiced any kind of meditation more than once a week in the past 3 months

Sites / Locations

  • TIRR Memorial Hermann

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness Meditation (MM) App

Engagement and Distraction (ED) App

Arm Description

Participants randomized to the MM condition will be asked to download and use the free Mindfulness Coach app (available for iOS and Android platforms) developed by the Veteran Affairs National Center for PTSD. The app offers written information about mindfulness as well as 12 audio-guided meditations each lasting 8-13 minutes. Participants will attend a live videochat orientation to the study with the research coordinator (RC) to receive assistance in downloading and using the app. Participants will be asked to listen to at least one, and ideally two, audio-guided meditation exercises using the app daily for six weeks. The RC will ask participants to complete weekly logs of their MM app use via a Qualtrics survey sent via email.

Participants randomized to the Engagement and Distraction condition will be asked to download and use the free TED Talk app (available for iOS and Android platforms). The app offers many videos of engaging and distracting presentations about technology, entertainment, and design. The research coordinator will work with the participant to create a customized list of Ted Talk videos, each lasting 6-12 minutes, based on participants' personal interests. Participants will be asked to listen to or watch at least one, and ideally two, presentations using the app daily for six weeks. The research coordinator will ask participants to complete weekly logs of their TED Talk app use via a Qualtrics survey sent via email.

Outcomes

Primary Outcome Measures

Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
proportion of assigned home practice completed by participants
Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment
proportion of participants who complete immediate post-intervention follow up assessment
Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment
proportion of participants who complete 6 weeks post-intervention follow up assessment
Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I)
participant reported satisfaction with their assigned condition; scores range from 12-48, with higher scores indicating greater satisfaction

Secondary Outcome Measures

International SCI Pain Basic Data Subset Questionnaire
Self-reported pain intensity and interference on a 0-10 scale with higher scores indicating greater pain intensity and interference
Chronic Pain Acceptance Questionnaire
Self-reported acceptance of pain; scores range from 0-156 with higher scores indicating greater acceptance of pain
Five Facet Mindfulness Questionnaire-Short Form
Self-reported mindfulness; scores range from 24-120 with higher scores indicating greater mindfulness
Patient Health Questionnaire-8 item
Depressive Symptoms; scores range from 0-24 with higher scores indicating greater depression symptoms
Generalized Anxiety Disorder Questionnaire-7
Anxiety Symptoms; scores range from 0-21 with higher scores indicating greater anxiety symptoms
SCI-QOL Positive Affect and Wellbeing Questionnaire
Self-reported Quality of Life; scores range from 10-50 with higher scores indicating greater quality of life

Full Information

First Posted
March 23, 2021
Last Updated
March 28, 2022
Sponsor
Baylor College of Medicine
Collaborators
The University of Texas Health Science Center, Houston, TIRR Memorial Hermann
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1. Study Identification

Unique Protocol Identification Number
NCT04818814
Brief Title
SCI Pain App Intervention Study
Official Title
SCI Pain App Intervention Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Terminated
Why Stopped
Lack of funding
Study Start Date
October 4, 2021 (Actual)
Primary Completion Date
February 28, 2022 (Actual)
Study Completion Date
February 28, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baylor College of Medicine
Collaborators
The University of Texas Health Science Center, Houston, TIRR Memorial Hermann

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to find out if using an app is a feasible and acceptable treatment for chronic pain in persons with spinal cord injury. Participants will have a 50% chance of being asked to listen to 10 minutes of audio-guided meditations using an app each day for six weeks, and a 50% chance of being asked to listen to 10 minutes of engaging and distracting presentations about topics of interest to the individual (TED Talks) for six weeks. All participants will be asked to complete three online surveys about their emotional and physical health lasting 20-30 minutes (one when the participant first enters the study, one six weeks later, and another six weeks later). Additionally, participants will be asked to complete brief (<5 minute) online surveys once a week during the first six weeks of their participation. Participation in this study is very low risk, and participants may not experience any personal benefit from their participation. Participation in this study is entirely voluntary.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Chronic Pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
11 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness Meditation (MM) App
Arm Type
Experimental
Arm Description
Participants randomized to the MM condition will be asked to download and use the free Mindfulness Coach app (available for iOS and Android platforms) developed by the Veteran Affairs National Center for PTSD. The app offers written information about mindfulness as well as 12 audio-guided meditations each lasting 8-13 minutes. Participants will attend a live videochat orientation to the study with the research coordinator (RC) to receive assistance in downloading and using the app. Participants will be asked to listen to at least one, and ideally two, audio-guided meditation exercises using the app daily for six weeks. The RC will ask participants to complete weekly logs of their MM app use via a Qualtrics survey sent via email.
Arm Title
Engagement and Distraction (ED) App
Arm Type
Active Comparator
Arm Description
Participants randomized to the Engagement and Distraction condition will be asked to download and use the free TED Talk app (available for iOS and Android platforms). The app offers many videos of engaging and distracting presentations about technology, entertainment, and design. The research coordinator will work with the participant to create a customized list of Ted Talk videos, each lasting 6-12 minutes, based on participants' personal interests. Participants will be asked to listen to or watch at least one, and ideally two, presentations using the app daily for six weeks. The research coordinator will ask participants to complete weekly logs of their TED Talk app use via a Qualtrics survey sent via email.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness Meditation App
Intervention Description
Listening to audio-guided meditation sessions using a mobile app.
Intervention Type
Behavioral
Intervention Name(s)
Engagement and Distraction App
Intervention Description
Listening to engaging and distracting videos of interest to the participant using a mobile app.
Primary Outcome Measure Information:
Title
Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
Description
proportion of assigned home practice completed by participants
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline)
Title
Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment
Description
proportion of participants who complete immediate post-intervention follow up assessment
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline)
Title
Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment
Description
proportion of participants who complete 6 weeks post-intervention follow up assessment
Time Frame
6 weeks post-intervention (i.e., 12-weeks post-baseline)
Title
Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I)
Description
participant reported satisfaction with their assigned condition; scores range from 12-48, with higher scores indicating greater satisfaction
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline)
Secondary Outcome Measure Information:
Title
International SCI Pain Basic Data Subset Questionnaire
Description
Self-reported pain intensity and interference on a 0-10 scale with higher scores indicating greater pain intensity and interference
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Title
Chronic Pain Acceptance Questionnaire
Description
Self-reported acceptance of pain; scores range from 0-156 with higher scores indicating greater acceptance of pain
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Title
Five Facet Mindfulness Questionnaire-Short Form
Description
Self-reported mindfulness; scores range from 24-120 with higher scores indicating greater mindfulness
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Title
Patient Health Questionnaire-8 item
Description
Depressive Symptoms; scores range from 0-24 with higher scores indicating greater depression symptoms
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Title
Generalized Anxiety Disorder Questionnaire-7
Description
Anxiety Symptoms; scores range from 0-21 with higher scores indicating greater anxiety symptoms
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Title
SCI-QOL Positive Affect and Wellbeing Questionnaire
Description
Self-reported Quality of Life; scores range from 10-50 with higher scores indicating greater quality of life
Time Frame
Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Other Pre-specified Outcome Measures:
Title
Patient Health Questionnaire-2 item
Description
Depressive Symptoms; scores range from 0-6 with higher scores indicating greater depression symptoms
Time Frame
Assessed weekly during the 6-week intervention
Title
Generalized Anxiety Disorder Questionnaire-2
Description
Anxiety Symptoms; scores range from 0-6 with higher scores indicating greater anxiety symptoms
Time Frame
Assessed weekly during the 6-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: are at least 18 years of age have a traumatic SCI of at least 6 months duration have chronic pain [defined as pain lasting at least 3 months with a pain intensity rating of 4 or higher on a 10-point visual analog scale] understand spoken and written English sufficiently to understand the goals, procedures, time involved, and the time involved in participation, participate in the intervention and complete study surveys. Exclusion Criteria: have a significant visual or hearing impairment that limits their ability to participate in the app/computer-based intervention lack access to and the ability to use a smart phone or smart tablet (e.g., iPad) are unable to provide or obtain an email address for communication practiced any kind of meditation more than once a week in the past 3 months
Facility Information:
Facility Name
TIRR Memorial Hermann
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
There is no plan to make IDP available to other researchers, aside from those directly involved in the project (i.e., listed on the study's IRB protocol at Baylor College of Medicine and the collaborating site, The University of Texas Health Science Center at Houston).

Learn more about this trial

SCI Pain App Intervention Study

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