Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
NCT ID: NCT03975075
Last Updated: 2024-08-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2019-10-01
2023-01-31
Brief Summary
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The expected duration of participation in this study is about 5 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 for the purpose of measuring heart rate and breathing. Those assigned to the biofeedback group will undergo 20 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 20 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 30 minutes to allow for completion of questionnaires over the the phone prior to and following each training session.
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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Psychophysiological monitoring
30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.
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.
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.
Psychophysiological monitoring
30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.
Interventions
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Psychophysiological monitoring
30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Craig Hospital
OTHER
Responsible Party
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Kimberley R Monden
Senior Principal Investigator
Locations
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Craig Hospital
Englewood, Colorado, United States
Countries
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References
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Monden KR, Nupp J, Ali A, MacIntyre B, Sevigny M, Hanks Philippus A. Exploring the feasibility of heart rate variability biofeedback for individuals with tetraplegia: A pilot clinical trial. Rehabil Psychol. 2025 May;70(2):214-225. doi: 10.1037/rep0000577. Epub 2024 Sep 9.
Other Identifiers
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594559
Identifier Type: -
Identifier Source: org_study_id
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