Spinal Cord InjuriesNCT03975075
Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
A study testing Psychophysiological monitoring and Biofeedback training in people with Spinal Cord Injuries and Anxiety, run by Craig Hospital at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injuries, Anxiety, Stress
- What is being tested?
- Psychophysiological monitoring and Biofeedback training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Oct 2019to 31 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Spinal Cord Injuries, Anxiety, Stress, Tetraplegia
- Being tested
- Psychophysiological monitoring, Biofeedback training
- Medical subject headings
- Spinal Cord Injuries, Anxiety Disorders, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychophysiological monitoringBehavioural
30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse.
Biofeedback trainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback | Experimental | 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. Receives: Behavioral: Psychophysiological monitoring; Behavioral: Biofeedback training |
| Control Group | Active comparator | 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. Receives: Behavioral: Psychophysiological monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in physiological stress
Average LF (ms2)
Measured: Session #1 (week 1) and Session #8 (week 4)
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.
Measured: Baseline (week 0) and Session #8 (week 4)
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.
Measured: Baseline (week 0) and Session #8 (week 4)
Secondary outcomes (2)
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.
Measured: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)
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.
Measured: After intervention sessions #1-8 (weeks 1 through 4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2019
- Study start1 Oct 2019
- Primary completion31 Jan 2023
- Study completion31 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Craig Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kimberley R Monden, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03975075
- Sponsor's protocol ID
- 594559
- Status last verified
- Aug 2024
- First submitted
- 16 May 2019
- Last updated
- 20 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Monden KR, Nupp J, Ali A, MacIntyre B, Sevigny M, Hanks Philippus A. Exploring the feasibility of heart rate variability biofeedback for individuals with tetraplegia: A pilot clinical trial. Rehabil Psychol. 2025 May;70(2):214-225. doi: 10.1037/rep0000577. Epub 2024 Sep 9.
PubMed 39250283
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback Treatment of Anxiety Associated With Chronic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT03975075
- Acronym / sponsor ID
- 594559
- Conditions
- Spinal Cord Injuries, Anxiety, Stress, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Craig HospitalUniversity, hospital or other
- Study start
- 1 Oct 2019 (actual)
- Primary completion
- 31 Jan 2023 (actual)
- Study completion
- 31 Jan 2023 (actual)
- First posted
- 5 Jun 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Biofeedback | Experimental | Behavioral: Psychophysiological monitoring, Behavioral: Biofeedback trainingParticipants (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. |
| Control Group | Active comparator | Behavioral: Psychophysiological monitoringParticipants (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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychophysiological monitoring30 minutes of one channel (ECG) physiological monitoring with Mindfield eSense Pulse. | Behavioural | Biofeedback, Control Group |
| Biofeedback trainingTraditional 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. | Behavioural | Biofeedback |
Primary outcome
Change in physiological stress
Time frame: Session #1 (week 1) and Session #8 (week 4)
Average LF (ms2)
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.
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.
2 secondary outcomes
Symptom list
Time frame: After intervention session #1 (week 1), before and after intervention sessions #2-8 (weeks 1 through 4)
State Trait Anxiety Inventory (STAI)
Time frame: After intervention sessions #1-8 (weeks 1 through 4)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2024.
- Derived from this study: PubMed 39250283Monden KR, Nupp J, Ali A, MacIntyre B, Sevigny M, Hanks Philippus A. Exploring the feasibility of heart rate variability biofeedback for individuals with tetraplegia: A pilot clinical trial. Rehabil Psychol. 2025 May;70(2):214-225. doi: 10.1037/rep0000577. Epub 2024 Sep 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychophysiological monitoring and Biofeedback training in people with Spinal Cord Injuries and Anxiety, run by Craig Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in physiological stress (time frame: Session #1 (week 1) and Session #8 (week 4)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03975075, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.