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

Spinal Cord Injuries Clinical Trial

Official title:

Feasibility of Mindfulness Meditation Training and Home Practice in Persons With Spinal Cord Injury: A Pilot Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05556057
• Other study ID #: HSC-MS-22-0035
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2022
• Est. completion date: October 30, 2024

Study information

• Verified date: January 2023
• Source: The University of Texas Health Science Center, Houston
• Contact: Radha Korupolu, MD
• Phone: 713-797-5233
• Email: Radha.Korupolu[@]uth.tmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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 information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 30, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Spinal Cord Injuries
• Wounds and Injuries

Intervention

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
• 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

Locations

Country	Name	City	State
United States	The University of Texas Health Science Center at Houston	Houston	Texas
United States	TIRR Memorial Hermann	Houston	Texas

Sponsors (4)

Lead Sponsor	Collaborator
The University of Texas Health Science Center, Houston	National Center for Complementary and Integrative Health (NCCIH), Sam Houston State University, TIRR Memorial Hermann

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility as assessed by the proportion of eligible people who provide consent		end of study at 3 years
Primary	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)
Primary	Feasibility as assessed by the number of participants that complete all visits	Visits include baseline, immediate post-intervention and 6-week follow-up assessments.	end of study (12 weeks post enrollment)
Primary	Acceptability as assessed by the patient-reported program evaluation questionnaire scale	This questionnaire has 12 questions each is scored form 1(no, definitely not) to 4(yes definitely), a higher score indicating more acceptability. The questionnaire also has 5 open ended questions where the subject can enter any recommendations to improve the app.	post-intervention (6 weeks post-enrollment)
Secondary	Feasibility of collecting patient reported outcomes of pain as assessed by the International SCI pain basic data subset (version 2)	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	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting patient reported outcomes of pain-related distress as assessed by the Chronic Pain Acceptance Questionnaire (CPAQ-R8)	This is a 20 item questionnaire,each is scored from 0(never true) to 6(always true), a higher number indicating higher acceptance	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting patient reported outcomes of brief pain as assessed by the Brief Pain Catastrophizing Scale (Brief PCS)	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	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting patient reported outcomes of anxiety as assessed by the General Anxiety Disorder-7 (GAD-7) questionnaire	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	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting patient reported outcomes of depression as assessed by the Patient Health Questionnaire (PHQ-8)	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).	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	feasibility of collecting patient reported outcomes of mindfulness, as assessed by the Five Facet Mindfulness Questionnaire-15 (FFMQ-15)	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	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	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)	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	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting perceived stress as assessed by the Perceived Stress Scale (PSS-4)	A four-item scale , each is scored from 0(never) to 4(very often) for a maximum score of 16 a higher score indicating more stress	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting fatigue as assessed by the PROMIS Fatigue- Short Form 4a	Each question has five response options ranging in value from five (very poor) to one (very good), a higher number indicating more fatigue.XX	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)
Secondary	Feasibility of collecting psychological inflexibility/experiential avoidance as assessed by the acceptance and Action Questionnaire (AAQ-2)	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.	Baseline, post-intervention (6 weeks post-enrollment), and end of study (12 weeks post enrollment)