Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

  • STATUS
    Recruiting
  • End date
    Apr 30, 2022
  • participants needed
    30
  • sponsor
    Craig Hospital
Updated on 22 June 2021
anxiety
spinal cord
quadriplegia
spinal cord disorder
biofeedback training

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.

Details
Condition Spinal Cord Injury, Myelopathy, Trauma, Quadriplegia, ANXIETY NEUROSIS, Anxiety, Stress, Anxiety Disorders (Pediatric), Generalized Anxiety Disorder (GAD), Generalized Anxiety Disorder (GAD - Pediatric), Anxiety Symptoms, Anxiety Disorders, Spinal Cord Injuries, Wounds, Spinal Cord Disorders, tetraplegia, anxiety disorder, anxious
Treatment Biofeedback Training, Psychophysiological monitoring
Clinical Study IdentifierNCT03975075
SponsorCraig Hospital
Last Modified on22 June 2021

Eligibility

Yes No Not Sure

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
History of participating in biofeedback training
Requires mechanical ventilation
Unable to travel to Craig for an initial assessment
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
Clear my responses

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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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