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

Primary Purpose

Spinal Cord Injuries

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

mindfulness meditation(MM)

Health Education (active control)

About this trial

This is an interventional other trial for Spinal Cord Injuries

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

The University of Texas Health Science Center at HoustonRecruiting
TIRR Memorial HermannRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

mindfulness meditation(MM)

Health Education

Arm Description

Outcomes

Primary Outcome Measures

Feasibility as assessed by the proportion of eligible people who provide consent

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

Feasibility as assessed by the number of participants that complete all visits

Visits include baseline, immediate post-intervention and 6-week follow-up assessments.

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.

Secondary Outcome Measures

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

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

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

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

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).

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

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

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

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

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.

Full Information

NCT ID

NCT05556057

First Posted

September 22, 2022

Last Updated

January 20, 2023

Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Sam Houston State University, TIRR Memorial Hermann

1. Study Identification

Unique Protocol Identification Number

NCT05556057

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

December 6, 2022 (Actual)

Primary Completion Date

July 15, 2024 (Anticipated)

Study Completion Date

October 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

The University of Texas Health Science Center, Houston

Collaborators

National Center for Complementary and Integrative Health (NCCIH), Sam Houston State University, TIRR Memorial Hermann

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Spinal Cord Injuries

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

mindfulness meditation(MM)

Arm Type

Experimental

Arm Title

Health Education

Arm Type

Active Comparator

Intervention Type

Other

Intervention Name(s)

mindfulness meditation(MM)

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Health Education (active control)

Intervention Description

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

Primary Outcome Measure Information:

Title

Feasibility as assessed by the proportion of eligible people who provide consent

Time Frame

end of study at 3 years

Title

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

Time Frame

post-intervention (6 weeks post-enrollment)

Title

Feasibility as assessed by the number of participants that complete all visits

Description

Visits include baseline, immediate post-intervention and 6-week follow-up assessments.

Time Frame

end of study (12 weeks post enrollment)

Title

Acceptability as assessed by the patient-reported program evaluation questionnaire scale

Description

Time Frame

post-intervention (6 weeks post-enrollment)

Secondary Outcome Measure Information:

Title

Feasibility of collecting patient reported outcomes of pain as assessed by the International SCI pain basic data subset (version 2)

Description

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

Time Frame