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Purpose

The purpose of this study is to evaluate the feasibility and acceptability of a 6-week app-guided Mindfulness meditation training (MM) intervention and health education (active control) condition in people with spinal cord injury (SCI) who have chronic pain and to examine the feasibility of data collection procedures

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • 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

Exclusion Criteria

  • Lack of daily access to the internet using a smart phone or smart tablet - Cognitive impairment (determined by their inability to demonstrate comprehension of informed consent by correctly answering 4 out of 5 questions pertaining to the study) - Significant visual/hearing impairment that does not allow use of the MM app's audiovisual presentations or health education presentations on Ted-talk - Use of any kind of meditation more than once a week in the last 3 months - Inability to provide or obtain an email address for communication with study staff

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Other
Masking
Single (Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
mindfulness meditation(MM)
  • Other: mindfulness meditation(MM)
    Participants will be provided with a unique invitation code that will allow them to download and use the free research version of the Mindfulness Coach app that is designed to deliver mindfulness training developed by the Veteran Affairs' National Center for PTSD.The app is tailored to users who may be skeptical about meditation practices by providing simple instructions and brief meditation exercises. The app offers written information about mindfulness as well as 12 audio-guided meditations each lasting 8-13 minutes, with an average length of 10 minutes
Active Comparator
Health Education
  • Other: Health Education (active control)
    Participants will be asked to download and use the free TED Talk app.Each participant's account will include a list of over 80 TED Talks related to the six broad categories of sleep, nutrition, mood, relationships, chronic pain, and health behaviors. These talks range from 4 to 18 minutes and were reviewed/selected by the investigator team. The research coordinator(RC) will instruct them to watch or listen to these videos for ≥ 10 minutes daily for 6 days per week. The RC will ask participants to complete weekly logs of their TED Talk app use

Recruiting Locations

The University of Texas Health Science Center at Houston
Houston, Texas 77030
Contact:
Shrasti Lohiya, MBBS
713-797-7920
scipainstudy@uth.tmc.edu

TIRR Memorial Hermann
Houston, Texas 77030
Contact:
Shrasti Lohiya, MBBS
713-797-7120
scipainstudy@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Radha Korupolu, MD
713-797-5233
Radha.Korupolu@uth.tmc.edu

Detailed Description

Our multidisciplinary, interinstitutional team of investigators proposes to randomize 60 SCI patients experiencing chronic pain to practice audio-guided MM for ≥ 10 minutes daily for 6 weeks using the free app "Mindfulness Coach" developed by the Department of Veteran Affairs, or to listen or view health education presentations (active control) ≥ 10 minutes daily for 6 weeks on the free TED app (active control). Primary outcomes are the feasibility and acceptability of proposed interventions in people with SCI and chronic pain. Secondary outcomes include the feasibility of collecting patient-reported outcomes of pain, anxiety, depression, mindfulness, quality of life, stress, fatigue and sleep disturbance.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.