Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Anxiety Clinical Trial

Official title:

Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03975075
• Other study ID #: 594559
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: January 31, 2023

Study information

• Verified date: February 2024
• Source: Craig Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: January 31, 2023
• Est. primary completion date: January 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Quadriplegia
• Spinal Cord Injuries
• Stress
• Tetraplegia
• Wounds and Injuries

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Craig Hospital	Englewood	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Craig Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Brief Pain Inventory (BPI) - 4 pain severity items	The Brief Pain Inventory (BPI) is one of the most widely used tools to assess pain. For this study, the four pain severity items will be used to assess worst, least, average, and current pain.	Baseline (week 0) and Session #8 (week 4)
Other	Brief Pain Inventory (BPI) - current pain severity item	A single item from the Brief Pain Inventory (BPI) will be used to assess the severity of current pain.	Before and after intervention Sessions #1-7 (weeks 1 - 3)
Other	Brief Pain Inventory (BPI) - pain relief item	A single item from the Brief Pain Inventory (BPI) has been modified from, "In the last 24 hours, how much relief have pain treatments or medications provided? Please mark the box below the percentage that most shows how much relief you have received" to read, "During this session, how much pain relief did you experience? Please indicate the percentage that best describes how much relief you received."	After each intervention Session #1-8 (weeks 1 - 4)
Other	Impact of study participation	Impact of Study Participation is a single open-ended item used to determine if study participation impacted anything other than stress, anxiety, or pain. Following the final session, participants will be asked, "Are there conditions other than stress, anxiety, or pain that were impacted by your participation in this study? If so, please list."	Session #8 (week 4)
Primary	Change in physiological stress	Average LF (ms2)	Session #1 (week 1) and Session #8 (week 4)
Primary	Change in Depression Anxiety Stress Scale-21 (DASS-21) scores	The Depression Anxiety Stress Scale-21 (DASS-21) is a self report instrument designed to measure core symptoms of depression, anxiety, and stress. Each of the three DASS-21 scales contains seven items, divided into subscales with similar content. Scores for depression, anxiety, and stress are calculated by summing the scores for the relevant items. Items are rated on a scale from 0 (did not apply to me at all) to 3 (applied to me very much or most of time), with higher scores indicating more depression, anxiety, and stress.	Baseline (week 0) and Session #8 (week 4)
Primary	Change in Subjective Units of Distress Scale (SUDS) scores	The Subjective Units of Distress Scale (SUDS) is a single-item self report instrument designed to measure the intensity of feelings and other internal experiences such as anxiety, anger, agitation, stress, or other painful feelings. A scale of 0 to 100 will be used to measure the subjective intensity of disturbance or distress experienced by the participant. A higher score indicates greater distress.	Baseline (week 0) and Session #8 (week 4)
Secondary	Symptom list	A list of self-reported symptoms will be used to track any new symptoms requiring medical attention that emerge during the course of the study.	After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)
Secondary	State Trait Anxiety Inventory (STAI)	The State Trait Anxiety Inventory (STAI) is a 40 item self-report inventory consisting of 20 items to assess trait anxiety and 20 items to assess state anxiety. Items are rated on a scale from 1 (not at all) to 4 (very much). A total score is calculated by summing all six scores, multiplying the sum by 20, and then dividing by six. Total scores range from 20 - 80 with higher scores indicating greater self-reported anxiety. A normal score on the STAI is 34 - 36.	After intervention sessions #1-8 (weeks 1 through 4)