SCI Pain App Intervention Study

Baylor College of Medicine

Status: Terminated

Conditions: Spinal Cord Injuries; Chronic Pain

Treatments: Behavioral: Engagement and Distraction App; Behavioral: Mindfulness Meditation App

Study type: Interventional

Funder types: Other

Identifiers

NCT04818814

H-47556

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Mindfulness Meditation (MM) App

Experimental group

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.

Treatment:

Behavioral: Mindfulness Meditation App

Engagement and Distraction (ED) App

Active Comparator group

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.

Treatment:

Behavioral: Engagement and Distraction App