Anxiety, Biofeedback, Psychology
Conditions
Keywords
Videogames, Commercial biofeedback device
Brief 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). 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.
Interventions
DEVICEBiofeedback 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.
DEVICEBiofeedback 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.
BEHAVIORALRelaxation training
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.
BEHAVIORALGaming only
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.
Sponsors
East Tennessee State University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Participant scores at least 1.5 standard deviations above the mean on any anxiety or stress-based scale (BAI or PSS), OR 2. Patient is assigned a CSR of 4 or higher on any anxiety disorder using the ADIS-5, OR 3. Patient exhibits maladaptive coping strategies, as demonstrated by COPE profile, AND 4. 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).
Exclusion criteria
1. Participant is not English-speaking. 2. 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.). 3. 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. 4. Any history of epileptic seizure activity which may be worsened by prolonged exposure to a computer screen. 5. Participant is unable to hold small object between thumb and forefinger. 6. Participant is unable to manipulate computer keyboard or computer mouse. 7. 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. 8. Participant is unable to wear a cheststrap heart monitor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Anxiety Disorders Interview Schedule - 5 (ADIS-5) | 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 | 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 | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Functional outcome (sleep) | Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8. | Subject report of average hours of sleep per night |
Outcome results
None listed