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Biofeedback training for Anxiety

N/A

Waitlist Available

Research Sponsored by Craig Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up after intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)

Awards & highlights

Study Summary

This trial is testing whether an intervention using biofeedback can help manage stress and anxiety for people with tetraplegia. It will last 5 weeks, with participants having two sessions a week that will last around 30 minutes each.

Eligible Conditions

Anxiety
Stress
Spinal Cord Injury
Quadriplegia

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ after intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~after intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)

This trial's timeline: 3 weeks for screening, Varies for treatment, and after intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Depression Anxiety Stress Scale-21 (DASS-21) scores

Change in Subjective Units of Distress Scale (SUDS) scores

Change in physiological stress

Secondary outcome measures

State Trait Anxiety Inventory (STAI)

Symptom list

Other outcome measures

Brief Pain Inventory (BPI) - 4 pain severity items

Brief Pain Inventory (BPI) - current pain severity item

Brief Pain Inventory (BPI) - pain relief item

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: BiofeedbackExperimental Treatment2 Interventions

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.

Group II: Control GroupActive Control1 Intervention

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

First Studied

Drug Approval Stage

How many patients have taken this drug

Biofeedback training

2013

N/A

~400

Psychophysiological monitoring

2019

N/A

~30

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Craig HospitalLead Sponsor

40 Previous Clinical Trials

8,329 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is the enrollment period for this trial still open?

"Per clinicaltrials.gov, this research is continuing to recruit patients at the present time. It was initially posted on October 1st 2019 and has recently been updated as of July 19th 2022."

Answered by AI

How many individuals have registered for this research experiment?

"Correct. Records on clinicaltrials.gov demonstrate that this experiment was initially advertised in October 2019 and has been actively recruiting patients since then, with the most recent update being July 19th 2022. The team is looking for 30 participants from a single site to participate."

Answered by AI

Does the research project accept elderly participants?

"This medical trial is open to adults aged 18 and over, who have yet to reach the age of 65."

Answered by AI

What qualifications must a potential participant possess to be eligible for this clinical trial?

"This clinical trial is recruiting 30 individuals aged between 18 and 65, who have sustained a spinal cord injury. To qualify for this study, participants must be willing to use the video-calling software Zoom, already discharged from inpatient rehabiliation, possess access to high-speed internet at home as well as own a mobile phone with HRV software installed on it."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Kimberley R Monden 2019. "Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03975075.