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Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03975075
Recruitment Status : Not yet recruiting
First Posted : June 5, 2019
Last Update Posted : June 5, 2019
Sponsor:
Information provided by (Responsible Party):
Kimberley Monden, Craig Hospital

Brief 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 15 hours over the course of 10-12 weeks. Participants will be randomly assigned to either a biofeedback training intervention or a control group. After completing questionnaires, participants will undergo physiological monitoring (measuring heart rate and breathing). Those assigned to the biofeedback group will undergo 30 minutes of physiological monitoring while also participating in biofeedback training twice a week for 4 weeks (8 sessions). Those assigned to the control group will undergo 30 minutes of physiological monitoring twice a week for 4 weeks (8 sessions), but will not receive biofeedback training. Each session is expected to last 1-1.5 hours. One week after the last session, participants will return to Craig Hospital to complete questionnaires and undergo 5 minutes of physiological monitoring.

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.


Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Anxiety Stress Tetraplegia Behavioral: Psychophysiological monitoring Behavioral: Biofeedback training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
Estimated Study Start Date : August 1, 2019
Estimated Primary Completion Date : April 30, 2020
Estimated Study Completion Date : April 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Biofeedback
Participants (n=15) will undergo psychophysiological monitoring while also participating in traditional resonance frequency training for a total of eight 30-minute sessions. Prior to beginning the heart rate variability (HRV) training session, participants will be introduced to the two channels (PPG and RSG) of the Thought Technology ProComp 2 Encoder and the Biograph Infinity software. 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 PPG and RSG feedback. Participants will be instructed on using controlled breathing to assist with reaching this relaxed state.
Behavioral: Psychophysiological monitoring
30 minutes of two channel (PPG and RSG) physiological monitoring with a Thought Technology ProComp 2 Encoder

Behavioral: Biofeedback training
Traditional resonance frequency training with the Thought Technology ProComp 2 Encoder and Biograph Infinity software. Using visual and auditory feedback of real time parameters of HRV and respiration rate and the use of controlled breathing, participants are trained to reach a relaxed state.

Active Comparator: Control Group
The control arm (n=15) participants will undergo physiological monitoring for eight 30-minute sessions. Before the initial session, a trained study staff will provide participants with an introductory explanation to the process of biofeedback and the associated equipment. Specifically, participants will be introduced to the two channels (PPG and RSG) of the Thought Technology ProComp 2 Encoder and the Biograph Infinity Version 6.2 software. The equipment will then be attached to the participants and they 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."
Behavioral: Psychophysiological monitoring
30 minutes of two channel (PPG and RSG) physiological monitoring with a Thought Technology ProComp 2 Encoder




Primary Outcome Measures :
  1. Change in physiological stress [ Time Frame: Week 0 (baseline) and Week 5 (post-treatment) ]
    Time to reach coherence (peak frequency of LF 0.04-0.15 Hz)

  2. Change in Depression Anxiety Stress Scale-21 (DASS-21) scores [ Time Frame: Week 0 (baseline) and Week 5 (post-treatment) ]
    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.

  3. Change in Subjective Units of Distress Scale (SUDS) scores [ Time Frame: Week 0 (baseline) and Week 5 (post-treatment) ]
    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.


Secondary Outcome Measures :
  1. Symptom list [ Time Frame: After intervention session #1(week 1), before and after intervention sessions #2-8 (weeks 1 through 4) ]
    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.

  2. State Trait Anxiety Inventory (STAI: Y-6) 6-item [ Time Frame: After intervention sessions #1-8 (weeks 1 through 4) ]
    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. To reduce participant burden, a validated six item version of the STAI (STAI: Y-6) will be used. 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:Y-6 is 34 - 36.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 65
  • Diagnosis of tetraplegia with residual sensory or motor impairments
  • Discharged from inpatient rehabilitation and living in the community

Exclusion Criteria:

  • Does not speak English
  • Scores less than 37 on the STAI: Y-6
  • Unable to travel to Craig for the four-week intervention
  • 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)
  • On medication that is known to interfere with biofeedback training (e.g., benzodiazepines)
  • Currently hospitalized for medical/rehabilitation treatment
  • Unable to commit to the four-week intervention

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03975075


Contacts
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Contact: Kimberley Monden, PhD 303.789.8562 kmonden@craighospital.org
Contact: Angie Philippus, MS 303.789.8030 aphilippus@craighospital.org

Sponsors and Collaborators
Craig Hospital

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Responsible Party: Kimberley Monden, Senior Principal Investigator, Craig Hospital
ClinicalTrials.gov Identifier: NCT03975075     History of Changes
Other Study ID Numbers: 594559
First Posted: June 5, 2019    Key Record Dates
Last Update Posted: June 5, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Anxiety Disorders
Wounds and Injuries
Mental Disorders
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations
Signs and Symptoms