SCI Pain App Intervention Study

Baylor College of Medicine11 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries Chronic Pain

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed

proportion of assigned home practice completed by participants

Time frame: 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

Time frame: 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

Time frame: 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

Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline)

Secondary Outcomes

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