SCI Pain App Intervention Study

NCT04818814 | Terminated

• 1 other identifier: H-47556
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries; Chronic Pain

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• International SCI Pain Basic Data Subset Questionnaire

  Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)

• Chronic Pain Acceptance Questionnaire

  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

  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

  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

  Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)

Other Outcomes (2)

• Patient Health Questionnaire-2 item

  Assessed weekly during the 6-week intervention

• Generalized Anxiety Disorder Questionnaire-2

  Assessed weekly during the 6-week intervention

Study Arms (2)

Mindfulness Meditation (MM) App

EXPERIMENTAL

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

Engagement and Distraction (ED) App

ACTIVE COMPARATOR

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

Interventions

Mindfulness Meditation App BEHAVIORAL

Listening to audio-guided meditation sessions using a mobile app.

Mindfulness Meditation (MM) App

Engagement and Distraction App BEHAVIORAL

Listening to engaging and distracting videos of interest to the participant using a mobile app.

Engagement and Distraction (ED) App

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Baylor College of Medicine: lead
• The University of Texas Health Science Center, Houston: collaborator
• TIRR Memorial Hermann: collaborator

Study Sites (1)

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: March 26, 2021
• Study Start: October 4, 2021
• Primary Completion: February 28, 2022
• Study Completion: February 28, 2022
• Last Updated: April 6, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)