Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury

NCT05556057 | Completed Results

• 2 other identifiers: HSC-MS-22-00351R34AT011530-01A1
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Spinal Cord Injuries

Outcome Measures

Primary Outcomes (5)

• Feasibility as Assessed by the Proportion of Eligible People Who Provide Consent

  end of study at 3 years

• Feasibility as Assessed by the Number of Participants Who Complete the Minimum Recommended Minutes (i.e., 60 Minutes/Per Week) of Using the MM or HE App During the 6 Weeks Intervention

  post-intervention (6 weeks post-enrollment)

• Feasibility as Assessed by the Number of Participants That Complete All Visits

  Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits, immediate post-intervention assessments, and 12-week follow-up assessments.

  end of study (12 weeks post enrollment)

• Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8

  The Client Satisfaction Questionnaire-8 measures satisfaction and the total score ranges from 8 to 32. The greater the score the higher satisfaction.

  post-intervention (6 weeks post-enrollment)

• Feasibility as Assessed by the Number of Participants That Complete All Visits

  Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits and immediate post-intervention assessments.

  post-intervention (6 weeks post-enrollment)

Secondary Outcomes (24)

• Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)

  Baseline

• Feasibility of Collecting Patient Reported Outcomes of Pain as Assessed by the Number of Participants Who Completed the International SCI Pain Basic Data Subset (Version 2)

  post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

• Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)

  baseline

• Feasibility of Collecting Patient Reported Outcomes of Pain-related Distress as Assessed by the Number of Participants Who Completed the Chronic Pain Acceptance Questionnaire (CPAQ-R8)

  post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)

• Feasibility of Collecting Patient Reported Outcomes of Brief Pain as Assessed by the Number of Participants Who Completed the Brief Pain Catastrophizing Scale (Brief PCS)

  Baseline

Study Arms (2)

mindfulness meditation(MM)

EXPERIMENTAL

Other: mindfulness meditation(MM)

Health Education

ACTIVE COMPARATOR

Other: Health Education (active control)

Interventions

mindfulness meditation(MM) OTHER

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

mindfulness meditation(MM)

Health Education (active control) OTHER

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

Health Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Inability to operate the app download or study related survey using a smartphone.

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator
• Sam Houston State University: collaborator
• TIRR Memorial Hermann: collaborator

Study Sites (2)

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

TIRR Memorial Hermann

Houston, Texas, 77030, United States

Location

Related Publications (1)

• Ratcliff CG, Lohiya S, Robinson-Whelen S, Taylor H, Ahn A, Korupolu R. Mindfulness buffers the association of pain with depression and anxiety among people with spinal cord injury: A cross-sectional study. Rehabil Psychol. 2024 Nov 11:10.1037/rep0000593. doi: 10.1037/rep0000593. Online ahead of print.

  PMID: 39531687 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Radha Korupolu, MD
• Organization: The University of Texas Health Science Center at Houston

Radha.Korupolu@uth.tmc.edu

713-797-5233

Study Officials

• Radha Korupolu, MD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

• Chelsea Ratcliff, PhD

  Sam Houston State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 22, 2022
• First Posted: September 27, 2022
• Study Start: December 6, 2022
• Primary Completion: July 16, 2024
• Study Completion: July 16, 2024
• Last Updated: August 14, 2025
• Results First Posted: August 14, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)