Clinical trial NCT04818814: SCI Pain App Intervention Study
Official title: SCI Pain App Intervention Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Spinal Cord Injuries
Chronic Pain
Lead sponsor: Baylor College of Medicine
Sponsor class: OTHER
Collaborators: name: The University of Texas Health Science Center, Houston
name: TIRR Memorial Hermann
First posted: 2021-03-26
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline)
measure: Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline)
measure: Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment
timeFrame: 6 weeks post-intervention (i.e., 12-weeks post-baseline)
measure: Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I)
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline)
Secondary outcomes:
measure: International SCI Pain Basic Data Subset Questionnaire
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
measure: Chronic Pain Acceptance Questionnaire
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
measure: Five Facet Mindfulness Questionnaire-Short Form
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
measure: Patient Health Questionnaire-8 item
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
measure: Generalized Anxiety Disorder Questionnaire-7
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
measure: SCI-QOL Positive Affect and Wellbeing Questionnaire
timeFrame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Other outcomes:
measure: Patient Health Questionnaire-2 item
timeFrame: Assessed weekly during the 6-week intervention
measure: Generalized Anxiety Disorder Questionnaire-2
timeFrame: Assessed weekly during the 6-week intervention
Locations:
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
References: