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出境医 / 临床实验 / Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Study Description
Brief Summary:

The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia.

The expected duration of participation in this study is about 15 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring (measuring heart rate and breathing) at Craig Hospital. Those assigned to the biofeedback group will undergo 30 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 30 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 1-1.5 hours. Following each training session, participants will respond to questionnaires over the phone.

It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Anxiety Stress Tetraplegia Behavioral: Psychophysiological monitoring Behavioral: Biofeedback training Not Applicable

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 30, 2022
Estimated Study Completion Date : April 30, 2022
Arms and Interventions
Arm Intervention/treatment
Experimental: Biofeedback
Participants (n=15) will undergo 30 minutes of self-administered 1-channel (ECG) physiological monitoring at home using the Mindfield eSense Pulse twice a week for four weeks (eight sessions in total). The biofeedback training session will be conducted using the eSense Pulse smartphone application. Participants will receive further instruction explaining how physiological information will be displayed and used as a means of training to induce a relaxed state while receiving real time feedback. Participants will be instructed on using controlled breathing to assist with reaching this relaxed state. Prior to each training session, the Study Coordinator will meet with the participant via Zoom to virtually assist with setup. Following each training session, participants will respond to questionnaires over the phone.
Behavioral: Psychophysiological monitoring
30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.

Behavioral: Biofeedback training
Traditional resonance frequency training with the Mindfield eSense Pulse smartphone application. Using visual feedback of real time parameters of HRV and the use of controlled breathing, participants are trained to reach a relaxed state.

Active Comparator: Control Group
Participants (n=15) will undergo 30 minutes of self-administered 1-channel (ECG) physiological monitoring at home using the Mindfield eSense Pulse twice a week for four weeks (eight sessions in total). Participants will be provided with the following instructions: "You will be monitored with this equipment for 30 minutes. During this time frame, please try to limit movement and conversation as much as possible." Prior to each training session, the Study Coordinator will meet with the participant via Zoom to virtually assist with setup. Following each training session, participants will respond to questionnaires over the phone.
Behavioral: Psychophysiological monitoring
30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.

Outcome Measures
Primary Outcome Measures :
  1. Change in physiological stress [ Time Frame: Session #1 (week 1) and Session #8 (week 4) ]
    Average LF (ms2)

  2. Change in Depression Anxiety Stress Scale-21 (DASS-21) scores [ Time Frame: Baseline (week 0) and Session #8 (week 4) ]
    The Depression Anxiety Stress Scale-21 (DASS-21) is a self report instrument designed to measure core symptoms of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Items are rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of time), with higher scores indicating more depression, anxiety, and stress.

  3. Change in Subjective Units of Distress Scale (SUDS) scores [ Time Frame: Baseline (week 0) and Session #8 (week 4) ]
    The Subjective Units of Distress Scale (SUDS) is a single-item self report instrument designed to measure the intensity of feelings and other internal experiences such as anxiety, anger, agitation, stress, or other painful feelings. A scale of 0 to 100 will be used to measure the subjective intensity of disturbance or distress experienced by the participant. A higher score indicates greater distress.


Secondary Outcome Measures :
  1. Symptom list [ Time Frame: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4) ]
    A list of self-reported symptoms will be used to track any new symptoms requiring medical attention that emerge during the course of the study.

  2. State Trait Anxiety Inventory (STAI) [ Time Frame: After intervention sessions #1-8 (weeks 1 through 4) ]
    The State Trait Anxiety Inventory (STAI) is a 40 item self-report inventory consisting of 20 items to assess trait anxiety and 20 items to assess state anxiety. Items are rated on a scale from 1 (not at all) to 4 (very much). A total score is calculated by summing all six scores, multiplying the sum by 20, and then dividing by six. Total scores range from 20 - 80 with higher scores indicating greater self-reported anxiety. A normal score on the STAI is 34 - 36.


Other Outcome Measures:
  1. Brief Pain Inventory (BPI) - 4 pain severity items [ Time Frame: Baseline (week 0) and Session #8 (week 4) ]
    The Brief Pain Inventory (BPI) is one of the most widely used tools to assess pain. For this study, the four pain severity items will be used to assess worst, least, average, and current pain.

  2. Brief Pain Inventory (BPI) - current pain severity item [ Time Frame: Before and after intervention Sessions #1-7 (weeks 1 - 3) ]
    A single item from the Brief Pain Inventory (BPI) will be used to assess the severity of current pain.

  3. Brief Pain Inventory (BPI) - pain relief item [ Time Frame: After each intervention Session #1-8 (weeks 1 - 4) ]
    A single item from the Brief Pain Inventory (BPI) has been modified from, "In the last 24 hours, how much relief have pain treatments or medications provided? Please mark the box below the percentage that most shows how much relief you have received" to read, "During this session, how much pain relief did you experience? Please indicate the percentage that best describes how much relief you received."

  4. Impact of study participation [ Time Frame: Session #8 (week 4) ]
    Impact of Study Participation is a single open-ended item used to determine if study participation impacted anything other than stress, anxiety, or pain. Following the final session, participants will be asked, "Are there conditions other than stress, anxiety, or pain that were impacted by your participation in this study? If so, please list."


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 65
  • Diagnosis of tetraplegia with residual sensory or motor impairments
  • Discharged from inpatient rehabilitation and living in the community
  • Access to high-speed internet at home
  • Willingness to download the videoconferencing software Zoom
  • Access to a mobile phone and willingness to download HRV software

Exclusion Criteria:

  • Does not speak English
  • Scores less than 37 on the STAI
  • Unable to travel to Craig for an initial assessment
  • History of participating in biofeedback training
  • Requires mechanical ventilation
  • Dependent on diaphragm pacer for respiration
  • Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)
  • Associated medical condition for which biofeedback is contraindicated (e.g., psychosis, pacemaker, or other implantable electric device)
  • Currently hospitalized for medical/rehabilitation treatment
  • Unable to commit to the four-week intervention
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Kimberley Monden, PhD 612-625-2661 kmonden@umn.edu
Contact: Angie Philippus, MS 303.789.8030 aphilippus@craighospital.org

Locations
Layout table for location information
United States, Colorado
Craig Hospital Recruiting
Englewood, Colorado, United States, 80113
Contact: Angela Philippus, MS    303-789-8030    aphilippus@craighospital.org   
Sponsors and Collaborators
Craig Hospital
Tracking Information
First Submitted Date  ICMJE May 16, 2019
First Posted Date  ICMJE June 5, 2019
Last Update Posted Date May 3, 2021
Actual Study Start Date  ICMJE October 1, 2019
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • Change in physiological stress [ Time Frame: Session #1 (week 1) and Session #8 (week 4) ]
    Average LF (ms2)
  • Change in Depression Anxiety Stress Scale-21 (DASS-21) scores [ Time Frame: Baseline (week 0) and Session #8 (week 4) ]
    The Depression Anxiety Stress Scale-21 (DASS-21) is a self report instrument designed to measure core symptoms of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Items are rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of time), with higher scores indicating more depression, anxiety, and stress.
  • Change in Subjective Units of Distress Scale (SUDS) scores [ Time Frame: Baseline (week 0) and Session #8 (week 4) ]
    The Subjective Units of Distress Scale (SUDS) is a single-item self report instrument designed to measure the intensity of feelings and other internal experiences such as anxiety, anger, agitation, stress, or other painful feelings. A scale of 0 to 100 will be used to measure the subjective intensity of disturbance or distress experienced by the participant. A higher score indicates greater distress.
Original Primary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Change in physiological stress [ Time Frame: Week 0 (baseline) and Week 5 (post-treatment) ]
    Time to reach coherence (peak frequency of LF 0.04-0.15 Hz)
  • Change in Depression Anxiety Stress Scale-21 (DASS-21) scores [ Time Frame: Week 0 (baseline) and Week 5 (post-treatment) ]
    The Depression Anxiety Stress Scale-21 (DASS-21) is a self report instrument designed to measure core symptoms of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Items are rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of time), with higher scores indicating more depression, anxiety, and stress.
  • Change in Subjective Units of Distress Scale (SUDS) scores [ Time Frame: Week 0 (baseline) and Week 5 (post-treatment) ]
    The Subjective Units of Distress Scale (SUDS) is a single-item self report instrument designed to measure the intensity of feelings and other internal experiences such as anxiety, anger, agitation, stress, or other painful feelings. A scale of 0 to 100 will be used to measure the subjective intensity of disturbance or distress experienced by the participant. A higher score indicates greater distress.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 9, 2019)
  • Symptom list [ Time Frame: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4) ]
    A list of self-reported symptoms will be used to track any new symptoms requiring medical attention that emerge during the course of the study.
  • State Trait Anxiety Inventory (STAI) [ Time Frame: After intervention sessions #1-8 (weeks 1 through 4) ]
    The State Trait Anxiety Inventory (STAI) is a 40 item self-report inventory consisting of 20 items to assess trait anxiety and 20 items to assess state anxiety. Items are rated on a scale from 1 (not at all) to 4 (very much). A total score is calculated by summing all six scores, multiplying the sum by 20, and then dividing by six. Total scores range from 20 - 80 with higher scores indicating greater self-reported anxiety. A normal score on the STAI is 34 - 36.
Original Secondary Outcome Measures  ICMJE
 (submitted: June 3, 2019)
  • Symptom list [ Time Frame: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4) ]
    A list of self-reported symptoms will be used to track any new symptoms requiring medical attention that emerge during the course of the study.
  • State Trait Anxiety Inventory (STAI: Y-6) 6-item [ Time Frame: After intervention sessions #1-8 (weeks 1 through 4) ]
    The State Trait Anxiety Inventory (STAI) is a 40 item self-report inventory consisting of 20 items to assess trait anxiety and 20 items to assess state anxiety. To reduce participant burden, a validated six item version of the STAI (STAI: Y-6) will be used. Items are rated on a scale from 1 (not at all) to 4 (very much). A total score is calculated by summing all six scores, multiplying the sum by 20, and then dividing by six. Total scores range from 20 - 80 with higher scores indicating greater self-reported anxiety. A normal score on the STAI:Y-6 is 34 - 36.
Current Other Pre-specified Outcome Measures
 (submitted: April 28, 2021)
  • Brief Pain Inventory (BPI) - 4 pain severity items [ Time Frame: Baseline (week 0) and Session #8 (week 4) ]
    The Brief Pain Inventory (BPI) is one of the most widely used tools to assess pain. For this study, the four pain severity items will be used to assess worst, least, average, and current pain.
  • Brief Pain Inventory (BPI) - current pain severity item [ Time Frame: Before and after intervention Sessions #1-7 (weeks 1 - 3) ]
    A single item from the Brief Pain Inventory (BPI) will be used to assess the severity of current pain.
  • Brief Pain Inventory (BPI) - pain relief item [ Time Frame: After each intervention Session #1-8 (weeks 1 - 4) ]
    A single item from the Brief Pain Inventory (BPI) has been modified from, "In the last 24 hours, how much relief have pain treatments or medications provided? Please mark the box below the percentage that most shows how much relief you have received" to read, "During this session, how much pain relief did you experience? Please indicate the percentage that best describes how much relief you received."
  • Impact of study participation [ Time Frame: Session #8 (week 4) ]
    Impact of Study Participation is a single open-ended item used to determine if study participation impacted anything other than stress, anxiety, or pain. Following the final session, participants will be asked, "Are there conditions other than stress, anxiety, or pain that were impacted by your participation in this study? If so, please list."
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Official Title  ICMJE Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Brief Summary

The purpose of this research is to test the feasibility of an intervention using biofeedback to treat stress and anxiety among individuals with tetraplegia.

The expected duration of participation in this study is about 15 hours over the course of about 5 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring (measuring heart rate and breathing) at Craig Hospital. Those assigned to the biofeedback group will undergo 30 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions) from home. Those assigned to the control group will undergo 30 minutes of physiological monitoring twice a week for 4 weeks (8 sessions) from home, but will not receive biofeedback training. Each session is expected to last 1-1.5 hours. Following each training session, participants will respond to questionnaires over the phone.

It is hypothesized that the biofeedback intervention will demonstrate high feasibility and compared to those in the control group, participants who receive the biofeedback intervention will attain greater pre-post reductions in both physiological and self-reported stress.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Spinal Cord Injuries
  • Anxiety
  • Stress
  • Tetraplegia
Intervention  ICMJE
  • Behavioral: Psychophysiological monitoring
    30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.
  • Behavioral: Biofeedback training
    Traditional resonance frequency training with the Mindfield eSense Pulse smartphone application. Using visual feedback of real time parameters of HRV and the use of controlled breathing, participants are trained to reach a relaxed state.
Study Arms  ICMJE
  • Experimental: Biofeedback
    Participants (n=15) will undergo 30 minutes of self-administered 1-channel (ECG) physiological monitoring at home using the Mindfield eSense Pulse twice a week for four weeks (eight sessions in total). The biofeedback training session will be conducted using the eSense Pulse smartphone application. Participants will receive further instruction explaining how physiological information will be displayed and used as a means of training to induce a relaxed state while receiving real time feedback. Participants will be instructed on using controlled breathing to assist with reaching this relaxed state. Prior to each training session, the Study Coordinator will meet with the participant via Zoom to virtually assist with setup. Following each training session, participants will respond to questionnaires over the phone.
    Interventions:
    • Behavioral: Psychophysiological monitoring
    • Behavioral: Biofeedback training
  • Active Comparator: Control Group
    Participants (n=15) will undergo 30 minutes of self-administered 1-channel (ECG) physiological monitoring at home using the Mindfield eSense Pulse twice a week for four weeks (eight sessions in total). Participants will be provided with the following instructions: "You will be monitored with this equipment for 30 minutes. During this time frame, please try to limit movement and conversation as much as possible." Prior to each training session, the Study Coordinator will meet with the participant via Zoom to virtually assist with setup. Following each training session, participants will respond to questionnaires over the phone.
    Intervention: Behavioral: Psychophysiological monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 3, 2019)
30
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 30, 2022
Estimated Primary Completion Date April 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age 18 to 65
  • Diagnosis of tetraplegia with residual sensory or motor impairments
  • Discharged from inpatient rehabilitation and living in the community
  • Access to high-speed internet at home
  • Willingness to download the videoconferencing software Zoom
  • Access to a mobile phone and willingness to download HRV software

Exclusion Criteria:

  • Does not speak English
  • Scores less than 37 on the STAI
  • Unable to travel to Craig for an initial assessment
  • History of participating in biofeedback training
  • Requires mechanical ventilation
  • Dependent on diaphragm pacer for respiration
  • Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)
  • Associated medical condition for which biofeedback is contraindicated (e.g., psychosis, pacemaker, or other implantable electric device)
  • Currently hospitalized for medical/rehabilitation treatment
  • Unable to commit to the four-week intervention
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Kimberley Monden, PhD 612-625-2661 kmonden@umn.edu
Contact: Angie Philippus, MS 303.789.8030 aphilippus@craighospital.org
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03975075
Other Study ID Numbers  ICMJE 594559
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kimberley R Monden, University of Minnesota
Study Sponsor  ICMJE Craig Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Craig Hospital
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP