AnxietyNCT03618121
Innovations in Biofeedback and Its Use in Mental Health
A study testing Biofeedback plus gaming (Nevermind), Biofeedback only (The Pip) and Relaxation training in people with Anxiety and Biofeedback, Psychology, run by East Tennessee State University.
Trial summary
This study investigates the use of new technologies in "biofeedback gaming" and their potential for use as a treatment for stress and anxiety. Biofeedback training is typically accomplished through devices that measure heartrate variability (HRV), galvanic skin response (GSR), or electroencephalogram (EEG). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Biofeedback, Psychology
- What is being tested?
- Biofeedback plus gaming (Nevermind), Biofeedback only (The Pip) and Relaxation training
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Jul 2017to 15 Jul 2019
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participant scores at least 1.5 standard deviations above the mean on any anxiety or stress-based scale (BAI or PSS), OR
- Patient is assigned a CSR of 4 or higher on any anxiety disorder using the ADIS-5, OR
- Patient exhibits maladaptive coping strategies, as demonstrated by COPE profile, AND
- Patient shows some level of functional impairment as a result of stress, anxiety, and/or restlessness (i.e. the symptoms are judged by clinician to be clinically meaningful).
Who cannot join
- Participant is not English-speaking.
- Participant appears to meet criteria for a comorbid psychiatric diagnosis that warrants alternative psychological treatment (e.g. PTSD, OCD, Major Mood Disorder, Substance Use Disorder, Psychotic Disorder, etc.).
- Any medical condition that would contraindicate participation in deep breathing practices associated with relaxation training. Some examples may include, but are not limited to, increased intracranial pressure, unstable head or neck injury, active hemorrhage, recent spinal injury, empyema, bronchopleural fistula, flail chest, uncontrolled hypertension, anticoagulation, rib or vertebral fractures or osteoporosis, acute asthma or tuberculosis, recent heart attack, recent skin grafts in chest area, spinal fusions, bony metastases, brittle bones, bronchial hemorrhage, emphysema, untreated pneumothorax, and chest tubes.
- Any history of epileptic seizure activity which may be worsened by prolonged exposure to a computer screen.
- Participant is unable to hold small object between thumb and forefinger.
- Participant is unable to manipulate computer keyboard or computer mouse.
- Participant has substantial visual deficit in both eyes, which cannot be corrected, that would interfere with ability view a small screen on a mobile device or a laptop screen.
- Participant is unable to wear a cheststrap heart monitor.
About this study
This study investigates the use of new technologies in "biofeedback gaming" and their potential for use as a treatment for stress and anxiety. Biofeedback training is typically accomplished through devices that measure heartrate variability (HRV), galvanic skin response (GSR), or electroencephalogram (EEG). Typically, the use of this equipment requires a practitioner with specialized training in reading and interpreting HRV, GSR, and/or EEG. However, recent advances in technology have made biofeedback devices more readily available to the general public, and some commercial devices are now being sold. This study investigates the utility of these commercial devices with a mild clinical population. In this study, participants use two tools for biofeedback training, one is called "The Pip," described in Group C, below, and another is a computer game called Nevermind, described in Groups A and B, below. These are compared against a control group (group D), which is standard relaxation training without biofeedback.
- Conditions
- Anxiety, Biofeedback, Psychology
- Being tested
- Biofeedback plus gaming (Nevermind), Biofeedback only (The Pip), Relaxation training, Gaming only
- Keywords
- Videogames, Commercial biofeedback device
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofeedback plus gaming (Nevermind)Device
Participants will receive relaxation training from a trained therapist while receiving biofeedback through the game Nevermind. Participants receive two 30-minute sessions per week, for 4 weeks, for a total of 8 sessions.
Biofeedback only (The Pip)Device
Participants receive relaxation training from a trained therapist with biofeedack through The Pip device. The Pip connects with 4 apps, The Loom, Relax \& Race, PipStressTracker, and Clarity. All 4 will be used in this study. Participants receive 2 30-minute sessions per week, for 4 weeks, for a total of 8 sessions.
Relaxation trainingBehavioural
Standard relaxation training protocol often used in clinical care. Participants receive 2 30-minute sessions per week, for 4 weeks, for a total of 8 sessions.
Gaming onlyBehavioural
Intervention is identical to the "Biofeedback plus gaming (Nevermind)" intervention, but in this case participants play Nevermind without any biofeedback. Thus, they receive 2 30-minute sessions of relaxation training per week, for 4 weeks, totaling 8 sessions. During relaxation training, they will play the Nevermind game, but without attaching to any biofeedback devices.
| Study group | Role | What they receive |
|---|---|---|
| Biofeedback plus gaming (Nevermind) | Experimental | 1) Group A is a biofeedback plus gaming group. Participants in this group play a horror videogame called Nevermind, while also wearing a chest strap heart rate monitor. The object of the videogame is to assist a patient by entering his/her mind and helping him/her work through some trauma memories. The way the game works is that the more anxious players are, the faster their heart beats, and the faster the heart beats, the harder and scarier the game gets. Thus, in order for one to do well in the game, he or she has to learn how to control the heartbeat and stress through relaxation. A therapist will help people in this group to learn relaxation techniques to help calm their body and finish the game. Receives: Device: Biofeedback plus gaming (Nevermind) |
| Gaming only | Active comparator | 2) Group B is a gaming only group. Like Group A, participants in this group play a Nevermind, but this time they do not wear a heart rate monitor. A therapist will still be present to help people in this group to learn relaxation techniques to help calm themselves during game play, but in this case the game does not change based on heart rate. Receives: Behavioral: Gaming only |
| Biofeedback only (The Pip) | Active comparator | 3) Group C is a biofeedback only group. In Group C, participants use a device called The Pip that measures Galvanic Skin Response. The Pip interacts with a few basic apps used in this study to teach relaxation. In one app, players control flying dragons. The more relaxed players are (as measured by GSR), the higher and faster their dragon flies. In another app, players control the changing of seasons. The more relaxed players are, the faster they can make seasons change from winter to spring. In another app, players can watch a simple graph of their stress over a period of time. Participants can learn to decrease stress by learning to make the line on the graph go down. In Group C, a therapist will also be present with participants to help them learn techniques to reduce stress. Receives: Device: Biofeedback only (The Pip) |
| Relaxation training only | Active comparator | 4) Group D is a relaxation training only group. In Group D, participants receive relaxation training from a trained therapist. Participants in this group learn and practice with their therapist different techniques to help them relax and reduce stress. Receives: Behavioral: Relaxation training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety Disorders Interview Schedule - 5 (ADIS-5)
Diagnostic interview for anxiety disorders
Measured: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Beck Anxiety Inventory
21-item symptom checklist. Total score will be used as outcome. Total score ranges from 0-63, with higher scores indicating more anxiety.
Measured: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
COPE
60-item measure assessing a broad range of coping responses. There are 15 subscales, each representing a different coping skill and each ranging in score from 4-16, with higher scores indicating more frequent usage of each of the 15 measured coping skills.
Measured: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Perceived Stress Scale
10-item measure of perceived stress. Total score used as primary outcomes. Total scores range from 0-40 with higher scores indicating higher levels of perceived stress.
Measured: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Secondary outcomes (1)
Functional outcome (sleep)
Subject report of average hours of sleep per night
Measured: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start15 Jul 2017 (estimated)
- Primary completion15 Jul 2019 (estimated)
- Study completion15 Jul 2019 (estimated)
Why it stopped: Primary Investigator is leaving host university (ETSU)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnxietyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jason Steadman, East Tennessee State University
- Investigators
- IRB Chairperson, Study chair, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618121
- Sponsor's protocol ID
- 0516.15f
- Status last verified
- Aug 2018
- First submitted
- 23 Jul 2018
- Last updated
- 8 Aug 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovations in Biofeedback and Its Use in Mental Health
- ClinicalTrials.gov ID
- NCT03618121
- Acronym / sponsor ID
- 0516.15f
- Conditions
- Anxiety, Biofeedback, Psychology
- Keywords
- Videogames, Commercial biofeedback device
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Primary Investigator is leaving host university (ETSU)
- Enrolment
- 0 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- 15 Jul 2017 (estimated)
- Primary completion
- 15 Jul 2019 (estimated)
- Study completion
- 15 Jul 2019 (estimated)
- First posted
- 7 Aug 2018 (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.
This study investigates the use of new technologies in "biofeedback gaming" and their potential for use as a treatment for stress and anxiety. Biofeedback training is typically accomplished through devices that measure heartrate variability (HRV), galvanic skin response (GSR), or electroencephalogram (EEG). Typically, the use of this equipment requires a practitioner with specialized training in reading and interpreting HRV, GSR, and/or EEG. However, recent advances in technology have made biofeedback devices more readily available to the general public, and some commercial devices are now being sold. This study investigates the utility of these commercial devices with a mild clinical population. In this study, participants use two tools for biofeedback training, one is called "The Pip," described in Group C, below, and another is a computer game called Nevermind, described in Groups A and B, below. These are compared against a control group (group D), which is standard relaxation training without biofeedback.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Biofeedback plus gaming (Nevermind) | Experimental | Device: Biofeedback plus gaming (Nevermind)1) Group A is a biofeedback plus gaming group. Participants in this group play a horror videogame called Nevermind, while also wearing a chest strap heart rate monitor. The object of the videogame is to assist a patient by entering his/her mind and helping him/her work through some trauma memories. The way the game works is that the more anxious players are, the faster their heart beats, and the faster the heart beats, the harder and scarier the game gets. Thus, in order for one to do well in the game, he or she has to learn how to control the heartbeat and stress through relaxation. A therapist will help people in this group to learn relaxation techniques to help calm their body and finish the game. |
| Gaming only | Active comparator | Behavioral: Gaming only2) Group B is a gaming only group. Like Group A, participants in this group play a Nevermind, but this time they do not wear a heart rate monitor. A therapist will still be present to help people in this group to learn relaxation techniques to help calm themselves during game play, but in this case the game does not change based on heart rate. |
| Biofeedback only (The Pip) | Active comparator | Device: Biofeedback only (The Pip)3) Group C is a biofeedback only group. In Group C, participants use a device called The Pip that measures Galvanic Skin Response. The Pip interacts with a few basic apps used in this study to teach relaxation. In one app, players control flying dragons. The more relaxed players are (as measured by GSR), the higher and faster their dragon flies. In another app, players control the changing of seasons. The more relaxed players are, the faster they can make seasons change from winter to spring. In another app, players can watch a simple graph of their stress over a period of time. Participants can learn to decrease stress by learning to make the line on the graph go down. In Group C, a therapist will also be present with participants to help them learn techniques to reduce stress. |
| Relaxation training only | Active comparator | Behavioral: Relaxation training4) Group D is a relaxation training only group. In Group D, participants receive relaxation training from a trained therapist. Participants in this group learn and practice with their therapist different techniques to help them relax and reduce stress. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Participant scores at least 1.5 standard deviations above the mean on any anxiety or stress-based scale (BAI or PSS), OR
- Patient is assigned a CSR of 4 or higher on any anxiety disorder using the ADIS-5, OR
- Patient exhibits maladaptive coping strategies, as demonstrated by COPE profile, AND
- Patient shows some level of functional impairment as a result of stress, anxiety, and/or restlessness (i.e. the symptoms are judged by clinician to be clinically meaningful).
Key exclusion criteria (8 listed)
- Participant is not English-speaking.
- Participant appears to meet criteria for a comorbid psychiatric diagnosis that warrants alternative psychological treatment (e.g. PTSD, OCD, Major Mood Disorder, Substance Use Disorder, Psychotic Disorder, etc.).
- Any medical condition that would contraindicate participation in deep breathing practices associated with relaxation training. Some examples may include, but are not limited to, increased intracranial pressure, unstable head or neck injury, active hemorrhage, recent spinal injury, empyema, bronchopleural fistula, flail chest, uncontrolled hypertension, anticoagulation, rib or vertebral fractures or osteoporosis, acute asthma or tuberculosis, recent heart attack, recent skin grafts in chest area, spinal fusions, bony metastases, brittle bones, bronchial hemorrhage, emphysema, untreated pneumothorax, and chest tubes.
- Any history of epileptic seizure activity which may be worsened by prolonged exposure to a computer screen.
- Participant is unable to hold small object between thumb and forefinger.
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 |
|---|---|---|
| Biofeedback plus gaming (Nevermind)Participants will receive relaxation training from a trained therapist while receiving biofeedback through the game Nevermind. Participants receive two 30-minute sessions per week, for 4 weeks, for a total of 8 sessions. | Device | Biofeedback plus gaming (Nevermind) |
| Biofeedback only (The Pip)Participants receive relaxation training from a trained therapist with biofeedack through The Pip device. The Pip connects with 4 apps, The Loom, Relax \& Race, PipStressTracker, and Clarity. All 4 will be used in this study. Participants receive 2 30-minute sessions per week, for 4 weeks, for a total of 8 sessions. | Device | Biofeedback only (The Pip) |
| Relaxation trainingStandard relaxation training protocol often used in clinical care. Participants receive 2 30-minute sessions per week, for 4 weeks, for a total of 8 sessions. | Behavioural | Relaxation training only |
| Gaming onlyIntervention is identical to the "Biofeedback plus gaming (Nevermind)" intervention, but in this case participants play Nevermind without any biofeedback. Thus, they receive 2 30-minute sessions of relaxation training per week, for 4 weeks, totaling 8 sessions. During relaxation training, they will play the Nevermind game, but without attaching to any biofeedback devices. | Behavioural | Gaming only |
Primary outcome
Anxiety Disorders Interview Schedule - 5 (ADIS-5)
Time frame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Diagnostic interview for anxiety disorders
Beck Anxiety Inventory
Time frame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
21-item symptom checklist. Total score will be used as outcome. Total score ranges from 0-63, with higher scores indicating more anxiety.
COPE
Time frame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
60-item measure assessing a broad range of coping responses. There are 15 subscales, each representing a different coping skill and each ranging in score from 4-16, with higher scores indicating more frequent usage of each of the 15 measured coping skills.
Perceived Stress Scale
Time frame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
10-item measure of perceived stress. Total score used as primary outcomes. Total scores range from 0-40 with higher scores indicating higher levels of perceived stress.
1 secondary outcome
Functional outcome (sleep)
Time frame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: No
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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.
IRB Chairperson study chair
East Tennessee State University
Questions about this trial
What is this clinical trial studying?
A study testing Biofeedback plus gaming (Nevermind), Biofeedback only (The Pip) and Relaxation training in people with Anxiety and Biofeedback, Psychology, run by East Tennessee State University.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 8 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Anxiety Disorders Interview Schedule - 5 (ADIS-5) (time frame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Aug 2018.