SCI Pain App Intervention Study

Chronic Pain Clinical Trial

Official title:

SCI Pain App Intervention Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT04818814
• Other study ID #: H-47556
• Status: Terminated
• Phase: N/A
• Start date: October 4, 2021
• Est. completion date: February 28, 2022

Study information

• Verified date: March 2022
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 11
• Est. completion date: February 28, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Spinal Cord Injuries

Intervention

Behavioral:
• Mindfulness Meditation App
Listening to audio-guided meditation sessions using a mobile app.
• Engagement and Distraction App
Listening to engaging and distracting videos of interest to the participant using a mobile app.

Locations

Country	Name	City	State
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (3)

Lead Sponsor	Collaborator
Baylor College of Medicine	The University of Texas Health Science Center, Houston, TIRR Memorial Hermann

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Primary	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)
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)