Spinal Cord InjuriesNCT04818814
SCI Pain App Intervention Study
A study testing Mindfulness Meditation App and Engagement and Distraction App in people with Spinal Cord Injuries and Chronic Pain, run by Baylor College of Medicine at 1 site in United States.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries, Chronic Pain
- What is being tested?
- Mindfulness Meditation App and Engagement and Distraction App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2021to 28 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
- Being tested
- Mindfulness Meditation App, Engagement and Distraction App
- Medical subject headings
- Spinal Cord Injuries, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness Meditation AppBehavioural
Listening to audio-guided meditation sessions using a mobile app.
Engagement and Distraction AppBehavioural
Listening to engaging and distracting videos of interest to the participant using a mobile app.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Engagement and Distraction App |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
proportion of assigned home practice completed by participants
Measured: 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
Measured: 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
Measured: 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
Measured: Immediately post-intervention (i.e., 6-weeks post-baseline)
Secondary outcomes (6)
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
Measured: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Chronic Pain Acceptance Questionnaire
Self-reported acceptance of pain; scores range from 0-156 with higher scores indicating greater acceptance of pain
Measured: 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
Self-reported mindfulness; scores range from 24-120 with higher scores indicating greater mindfulness
Measured: 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
Depressive Symptoms; scores range from 0-24 with higher scores indicating greater depression symptoms
Measured: 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
Anxiety Symptoms; scores range from 0-21 with higher scores indicating greater anxiety symptoms
Measured: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
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
Measured: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start4 Oct 2021
- Primary completion28 Feb 2022
- Study completion28 Feb 2022
Why it stopped: Lack of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- More trials run by Baylor College of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baylor College of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, TIRR Memorial Hermann
- Responsible party
- Principal investigator, Susan Robinson Whelen, Baylor College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04818814
- Sponsor's protocol ID
- H-47556
- Status last verified
- Mar 2022
- First submitted
- 23 Mar 2021
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IDP available to other researchers, aside from those directly involved in the project (i.e., listed on the study's IRB protocol at Baylor College of Medicine and the collaborating site, The University of Texas Health Science Center at Houston).
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SCI Pain App Intervention Study
- ClinicalTrials.gov ID
- NCT04818814
- Acronym / sponsor ID
- H-47556
- Conditions
- Spinal Cord Injuries, Chronic Pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of funding
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Baylor College of MedicineUniversity, hospital or other
- Collaborators
- The University of Texas Health Science Center, Houston, TIRR Memorial Hermann
- Study start
- 4 Oct 2021 (actual)
- Primary completion
- 28 Feb 2022 (actual)
- Study completion
- 28 Feb 2022 (actual)
- First posted
- 26 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Meditation (MM) App | Experimental | Behavioral: Mindfulness Meditation AppParticipants 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. |
| Engagement and Distraction (ED) App | Active comparator | Behavioral: Engagement and Distraction AppParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness Meditation AppListening to audio-guided meditation sessions using a mobile app. | Behavioural | Mindfulness Meditation (MM) App |
| Engagement and Distraction AppListening to engaging and distracting videos of interest to the participant using a mobile app. | Behavioural | Engagement and Distraction (ED) App |
Primary outcome
Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed
Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline)
proportion of assigned home practice completed by participants
Feasibility of Immediate Post-Intervention Follow-Up Assessment as assessed by the proportion of participants who complete immediate post-intervention follow up assessment
Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline)
proportion of participants who complete immediate post-intervention follow up assessment
Feasibility of 6-Week Follow-Up Assessment as assessed by the proportion of participants who complete 6 weeks post-intervention follow up assessment
Time frame: 6 weeks post-intervention (i.e., 12-weeks post-baseline)
proportion of participants who complete 6 weeks post-intervention follow up assessment
Participant Satisfaction as assessed by a satisfaction questionnaire adapted from the Client Satisfaction Questionnaire for Internet-based Interventions (CSQ-I)
Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline)
participant reported satisfaction with their assigned condition; scores range from 12-48, with higher scores indicating greater satisfaction
6 secondary outcomes
International SCI Pain Basic Data Subset Questionnaire
Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Chronic Pain Acceptance Questionnaire
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
SCI-QOL Positive Affect and Wellbeing Questionnaire
Time frame: Immediately post-intervention (i.e., 6-weeks post-baseline) and 6 weeks post-intervention (i.e., 12-weeks post-baseline)
Results and safety
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
- Individual participant dataSharing planned: No. There is no plan to make IDP available to other researchers, aside from those directly involved in the project (i.e., listed on the study's IRB protocol at Baylor College of Medicine and the collaborating site, The University of Texas Health Science Center at Houston).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness Meditation App and Engagement and Distraction App in people with Spinal Cord Injuries and Chronic Pain, run by Baylor College of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Lack of funding). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Daily Practice as assessed by the proportion of assigned home practice completed (time frame: Immediately post-intervention (i.e., 6-weeks post-baseline)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2022.