Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Craig Hospital

Status: Completed

Conditions: Tetraplegia; Spinal Cord Injuries; Anxiety; Stress

Treatments: Behavioral: Psychophysiological monitoring; Behavioral: Biofeedback training

Study type: Interventional

Funder types: Other

Identifiers

NCT03975075

594559

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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30 participants in 2 patient groups

Biofeedback

Experimental group

Description:

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.

Treatment:

Behavioral: Biofeedback training

Behavioral: Psychophysiological monitoring

Control Group

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychophysiological monitoring