Clinical trial NCT03618121: Innovations in Biofeedback and Its Use in Mental Health
Official title: Innovations in Biofeedback and Its Use in Mental Health
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Anxiety
Biofeedback, Psychology
Keywords: Videogames
Commercial biofeedback device
Lead sponsor: East Tennessee State University
Sponsor class: OTHER
First posted: 2018-08-07
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Anxiety Disorders Interview Schedule - 5 (ADIS-5)
timeFrame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
measure: Beck Anxiety Inventory
timeFrame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
measure: COPE
timeFrame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
measure: Perceived Stress Scale
timeFrame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Secondary outcomes:
measure: Functional outcome (sleep)
timeFrame: Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.
Other outcomes:
Locations:
Study officials:
affiliation: East Tennessee State University
name: IRB Chairperson
role: STUDY_CHAIR
References: