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Completed

NCT Number: NCT03975075

Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury

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.

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Key information

Conditions

Spinal Cord Injuries Anxiety Anxiety Disorders Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Quadriplegia Signs and Symptoms Spinal Cord Diseases Stress Tetraplegia Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Craig Hospital

Englewood, Colorado, 80113, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Psychophysiological monitoring

Behavioral

30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.

biofeedback training

Behavioral

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.

Primary outcomes

  1. Change in physiological stress

    Time frame: Session #1 (week 1) and Session #8 (week 4)

    Average LF (ms2)

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

    Time frame: Baseline (week 0) and Session #8 (week 4)

    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: Baseline (week 0) and Session #8 (week 4)

    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 outcomes

  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)

    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. 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.

Other outcomes

  1. Brief Pain Inventory (BPI) - 4 pain severity items

    Time frame: Baseline (week 0) and Session #8 (week 4)

    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.

  2. Brief Pain Inventory (BPI) - current pain severity item

    Time frame: Before and after intervention Sessions #1-7 (weeks 1 - 3)

    A single item from the Brief Pain Inventory (BPI) will be used to assess the severity of current pain.

  3. Brief Pain Inventory (BPI) - pain relief item

    Time frame: After each intervention Session #1-8 (weeks 1 - 4)

    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."

  4. Impact of study participation

    Time frame: Session #8 (week 4)

    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."

Sponsors and collaborators

Lead sponsor

Craig Hospital

Other

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Jun 5, 2019
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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