Effects of a Mobile App-Based Mindfulness Intervention in Persons With Spinal Cord Injury and Chronic Pain

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMayo Clinic

About this trial

The purpose of this study is to evaluate the efficacy of a 6-week app-guided MM intervention compared to a 6-week app-guided health education AC condition on pain intensity, pain interference, depression, and anxiety.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Traumatic SCI of at least 6 months duration

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 provide informed consent, participate in the intervention and complete study surveys

Disqualifiers

Lack of daily internet access

Inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions about the study

Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations

Use of any meditation more than once a week in the last 3 months

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness meditation (MM) Intervention

    Other intervention

    Participants will be asked to download the Mindfulness Coach app that provides simple instructions and brief meditation exercises.This is a a gradual training program of 14 levels which will be completed in the first 2-3 weeks. Each level provides short readings about mindfulness and one or two guided meditations (a silent "seated practice" for increasing lengths of time plus typically an additional 8-13-minute meditation). As participants progress through the levels, they earn "badges" displayed in the app, and an image of a tree on the home screen grows as each successive level is completed.For the remaining weeks of the intervention, participants will select at least one (and ideally two) guided meditation per day from the complete list of available meditations.Participants will track their progress through weekly logs.

  • Health Education Active Control Intervention

    Other intervention

    Participants will be asked to download and use the free TED Talk app, which will have 50 TED talk videos related to health that range from 3-20 minutes. Participants will be asked to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week and complete weekly logs of the TED Talk app use.

Treatment groups

282 Participants
are divided into 2 treatment groups
Group A: Mindfulness meditation (MM)Experimental treatment 1 intervention
Group B: Active Control (AC)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in Pain intensity in people with spinal cord injury (PwSCI) as assessed by Numeric Rating Scale (NRS).

Pain will be measured on Numeric Rating Scale (NRS) from 0(no pain) to 10(pain as bad as you can imagine)

Time frame
baseline , post-intervention (6 weeks after baseline)

Secondary outcomes

1

Change in pain interference as assessed by the Spinal Cord Injury - Quality of Life (SCI-QOL) Pain Interference scale

This is a 10 item questionnaire, each item is typically scored on a 5-point Likert scale from 1 (Not at all) to 5 (Very much), for a maximum raw score of 50, higher scores reflect greater pain interference.

Time frame
baseline , post-intervention (6 weeks after baseline)
2

Change in depression as assessed by the Patient Health Questionnaire (PHQ-9)

This is a 8 item questionnaire , each measured on a 4 point scale from 0(not at all) to 3(nearly every day), for a score range of 0-27, higher score indicating worse outcome

Time frame
baseline , post-intervention (6 weeks after baseline)
3

Change in anxiety as assessed by the Generalized Anxiety Disorder (GAD-7)

This is an 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day), for a maximum score of 21, a higher score indicating more anxiety

Time frame
baseline , post-intervention (6 weeks after baseline)

Other outcomes

Sponsors and contacts

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