Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Completed · Not applicable

Conditions studied: Spinal Cord Injuries, Anxiety, Stress, Tetraplegia

In brief

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 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.

Key facts

Study ID

NCT03975075

Run by

Craig Hospital

People needed

30

Starts

2019-10-01

Expected to finish

2023-01-31

Last updated by the study team

2024-08-20

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Craig Hospital — Englewood, Colorado, United States

Full record on ClinicalTrials.gov

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