Innovations in Biofeedback and Its Use in Mental Health

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 Overview

• Status: Withdrawn
• Conditions: Anxiety; Biofeedback, Psychology
• Intervention / Treatment: Device: Biofeedback plus gaming (Nevermind); Behavioral: Gaming only; Device: Biofeedback only (The Pip); Behavioral: Relaxation training

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: 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.
ACTIVE_COMPARATOR: Gaming only; 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.	Behavioral: Gaming 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.
ACTIVE_COMPARATOR: 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.	Device: 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.
ACTIVE_COMPARATOR: Relaxation training only; 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.	Behavioral: Relaxation 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anxiety Disorders Interview Schedule - 5 (ADIS-5)	Diagnostic interview for anxiety disorders	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.	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.	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.	Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Functional outcome (sleep)	Subject report of average hours of sleep per night	Baseline, post-treatment change in outcome 4 days after session 8, and follow-up change in outcome 6-weeks after session 8.

Collaborators and Investigators

• Sponsor: East Tennessee State University
• Investigators: Study Chair: IRB Chairperson, East Tennessee State University

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): July 15, 2017
• Primary Completion (ANTICIPATED): July 15, 2019
• Study Completion (ANTICIPATED): July 15, 2019

Study Registration Dates

• First Submitted: July 23, 2018
• First Submitted That Met QC Criteria: August 1, 2018
• First Posted (ACTUAL): August 7, 2018

Study Record Updates

• Last Update Posted (ACTUAL): August 8, 2018
• Last Update Submitted That Met QC Criteria: August 7, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Keywords: Videogames; Commercial biofeedback device
• Other Study ID Numbers: 0516.15f

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No