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

Not Applicable

Completed

Conditions: Spinal Cord Injuries

Registration Number: NCT05556057

Lead Sponsor: The University of Texas Health Science Center, Houston

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

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 65

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	post-intervention (6 weeks post-enrollment)	Number of participants that complete all visits defined as participants who completed all study assessments, including baseline visits and immediate post-intervention assessments.
Acceptability Rate as Assessed by the Number of Participants Who Scored 20 or Greater on the Modified Client Satisfaction Questionnaire-8	post-intervention (6 weeks post-enrollment)	The Client Satisfaction Questionnaire-8 measures satisfaction and the total score ranges from 8 to 32. The greater the score the higher satisfaction.

Secondary Outcome Measures

Name	Time	Method
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)	This survey contains 11 questions and each one is measured from 0(no pain) to 10(chronic pain),with a maximum score of 110, a higher number indicating more pain
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)	This is a 20 item questionnaire, each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance
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)	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	This measures three aspects of catastrophic cognitions about pain-rumination, magnification, and helplessness. This is a 13 item questionnaire. Each question has five response options ranging from 0 (not at all) to 4 (all the time) scale, with a maximum score of 52
Feasibility of Collecting Patient Reported Outcomes of Anxiety as Assessed by the Number of Participants Who Completed the General Anxiety Disorder-7 (GAD-7) Questionnaire	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	This is an 7 item questionnaire, each is scored from 0(not at all) to 3(nearly every day), a higher score indicating more anxiety
Feasibility of Collecting Patient Reported Outcomes of Depression as Assessed by the Number of Participants Who Completed the Patient Health Questionnaire (PHQ-8)	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	This is an 8 item questionnaire.Each question is scored from 0 to 1 day = "not at all," 2 to 6 days = "several days," 7 to 11 days = "more than half the days," and 12 to 14 days = "nearly every day". Total score is determined by adding together the scores of each of the four items. Scores are rated as normal (0-2), mild (3-5), moderate (6-8), and severe (9-12).
Feasibility of Collecting Patient Reported Outcomes of Mindfulness as Assessed by the Number of Participants Who Completed the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	This is a 15 item questionnaire, each is scored from 1(never or very rarely true) to 5(very often or always true) for a maximum score of 120, higher score indicating more mindfulness
Feasibility of Collecting Patient Reported Outcomes of Quality of Life as Assessed by the Number of Participants Who Completed the SCI-quality of Life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	This is a 10 item scale each scored from (1)never to (5)always, with a maximum score of 50 a higher number indicating a better outcome
Feasibility of Collecting Perceived Stress as Assessed by the Number of Participants Who Completed the Perceived Stress Scale (PSS-4)	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	The Perceived Stress Scale (PSS-4) is a four-item scale, each item is scored from 0(never) to 4(very often). The total score ranges from 0 to 16, a higher score indicating more stress
Feasibility of Collecting Fatigue as Assessed by the Number of Participants Who Completed the PROMIS Fatigue- Short Form 4a	post-intervention (6 weeks post-enrollment), end of study (12 weeks post enrollment)	Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.
Feasibility of Collecting Psychological Inflexibility/Experiential Avoidance as Assessed by the Number of Participants Who Completed the Acceptance and Action Questionnaire (AAQ-2)	end of study (12 weeks post enrollment)	This contains 7 items and answers are given on a 7-point scale ranging from 1 (never true) to 7 (always true). High scores on the AAQ-2 are reflective of greater experiential avoidance and immobility, while low scores reflect greater acceptance and action.
Feasibility of Collecting Sleep Disturbance as Assessed by the Number of Participants Who Completed the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a	end of study (12 weeks post enrollment)	This is a 4 item questionnaire and each question has five response options ranging in value from five (very poor) to one (very good) for a maximum score of 16, higher number indicating worse outcome.

Trial Locations

Locations (2): The University of Texas Health Science Center at Houston
🇺🇸
Houston, Texas, United States
TIRR Memorial Hermann
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Houston, Texas, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States