Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Not Applicable

Completed

• Conditions: Spinal Cord Injuries; Anxiety; Stress; Tetraplegia

• Registration Number: NCT03975075
• Lead Sponsor: Craig Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-5-16
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - Age 18 to 65<br><br> - Diagnosis of tetraplegia with residual sensory or motor impairments<br><br> - Discharged from inpatient rehabilitation and living in the community<br><br> - Access to high-speed internet at home<br><br> - Willingness to download the videoconferencing software Zoom<br><br> - Access to a mobile phone and willingness to download HRV software<br><br>Exclusion Criteria:<br><br> - Does not speak English<br><br> - Scores less than 37 on the STAI<br><br> - Unable to travel to Craig for an initial assessment<br><br> - History of participating in biofeedback training<br><br> - Requires mechanical ventilation<br><br> - Dependent on diaphragm pacer for respiration<br><br> - Currently in treatment for anxiety (e.g., pharmacologic or psychotherapeutic)<br><br> - Associated medical condition for which biofeedback is contraindicated (e.g.,<br> psychosis, pacemaker, or other implantable electric device)<br><br> - Currently hospitalized for medical/rehabilitation treatment<br><br> - Unable to commit to the four-week intervention

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in physiological stress;Change in Depression Anxiety Stress Scale-21 (DASS-21) scores;Change in Subjective Units of Distress Scale (SUDS) scores

Secondary Outcome Measures

Name	Time	Method
Symptom list;State Trait Anxiety Inventory (STAI)