SCI Pain App Intervention Study

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.

Study Overview

• Status: Terminated
• Conditions: Chronic Pain; Spinal Cord Injuries
• Intervention / Treatment: Behavioral: Mindfulness Meditation App; Behavioral: Engagement and Distraction App

• Study Type: Interventional
• Enrollment (Actual): 11
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77030
      • TIRR Memorial Hermann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness Meditation (MM) App; 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.	Behavioral: Mindfulness Meditation App; Listening to audio-guided meditation sessions using a mobile app.
Active Comparator: Engagement and Distraction (ED) App; 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.	Behavioral: Engagement and Distraction App; Listening to engaging and distracting videos of interest to the participant using a mobile app.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed	proportion of assigned home practice completed by participants	Immediately post-intervention (i.e., 6-weeks post-baseline)
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	Immediately post-intervention (i.e., 6-weeks post-baseline)
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	6 weeks post-intervention (i.e., 12-weeks post-baseline)
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	Immediately post-intervention (i.e., 6-weeks post-baseline)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Chronic Pain Acceptance Questionnaire	Self-reported acceptance of pain; scores range from 0-156 with higher scores indicating greater acceptance of pain	Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Five Facet Mindfulness Questionnaire-Short Form	Self-reported mindfulness; scores range from 24-120 with higher scores indicating greater mindfulness	Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Patient Health Questionnaire-8 item	Depressive Symptoms; scores range from 0-24 with higher scores indicating greater depression symptoms	Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Generalized Anxiety Disorder Questionnaire-7	Anxiety Symptoms; scores range from 0-21 with higher scores indicating greater anxiety symptoms	Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
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	Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Health Questionnaire-2 item	Depressive Symptoms; scores range from 0-6 with higher scores indicating greater depression symptoms	Assessed weekly during the 6-week intervention
Generalized Anxiety Disorder Questionnaire-2	Anxiety Symptoms; scores range from 0-6 with higher scores indicating greater anxiety symptoms	Assessed weekly during the 6-week intervention

Collaborators and Investigators

• Sponsor: Baylor College of Medicine
• Collaborators: The University of Texas Health Science Center, Houston; TIRR Memorial Hermann

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2021
• Primary Completion (Actual): February 28, 2022
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: March 23, 2021
• First Submitted That Met QC Criteria: March 25, 2021
• First Posted (Actual): March 26, 2021

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Wounds and Injuries; Trauma, Nervous System; Spinal Cord Diseases; Chronic Pain; Spinal Cord Injuries
• Other Study ID Numbers: H-47556

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD 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).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No