Clinical trial NCT05556057: Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury
Official title: Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
name: Sam Houston State University
name: TIRR Memorial Hermann
First posted: 2022-09-27
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility as assessed by the proportion of eligible people who provide consent
timeFrame: end of study at 3 years
measure: 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
timeFrame: post-intervention (6 weeks post-enrollment)
measure: Feasibility as assessed by the number of participants that complete all visits
timeFrame: end of study (12 weeks post enrollment)
measure: Acceptability as assessed by the patient-reported program evaluation questionnaire scale
timeFrame: post-intervention (6 weeks post-enrollment)
Secondary outcomes:
measure: Feasibility of collecting patient reported outcomes of pain as assessed by the International SCI pain basic data subset (version 2)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting patient reported outcomes of pain-related distress as assessed by the Chronic Pain Acceptance Questionnaire (CPAQ-R8)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting patient reported outcomes of brief pain as assessed by the Brief Pain Catastrophizing Scale (Brief PCS)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting patient reported outcomes of anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting patient reported outcomes of depression as assessed by the Patient Health Questionnaire (PHQ-8)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: feasibility of collecting patient reported outcomes of mindfulness, as assessed by the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting patient reported outcomes of quality of life as assessed by the SCI-quality of life (QOL): Positive Affect and Well Being-Short Form (PAWB-SF)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting perceived stress as assessed by the Perceived Stress Scale (PSS-4)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting fatigue as assessed by the PROMIS Fatigue- Short Form 4a
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of collecting psychological inflexibility/experiential avoidance as assessed by the acceptance and Action Questionnaire (AAQ-2)
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
measure: Feasibility of sleep disturbance as assessed by the Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance- Short Form 4a
timeFrame: Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Other outcomes:
Locations:
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: Houston
country: United States
facility: TIRR Memorial Hermann
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Radha Korupolu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Sam Houston State University
name: Chelsea Ratcliff, PhD
role: PRINCIPAL_INVESTIGATOR
References: