Innovations in Biofeedback and Its Use in Mental Health

Anxiety Clinical Trial

Official title:

Innovations in Biofeedback and Its Use in Mental Health

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03618121
• Other study ID #: 0516.15f
• Status: Withdrawn
• Phase: N/A
• Start date: July 15, 2017
• Est. completion date: July 15, 2019

Study information

• Verified date: August 2018
• Source: East Tennessee State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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). 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 15, 2019
• Est. primary completion date: July 15, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Biofeedback, Psychology

Intervention

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.
• 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.

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
East Tennessee State University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.