Biofeedback-aided Intervention for Self-regulation

The investigators propose a randomized controlled trial (RCT) to investigate the feasibility and efficacy of non-intrusive biofeedback devices that can be worn throughout the day in providing therapeutic cues to college students suffering from chronic anxiety. The biofeedback device detects physiological stress indices in real time (e.g., changes in breathing rate) and provides feedback (e.g., through minor vibration or text messages) serving as a cue to the wearer to recall therapeutic steps at exactly those moments they need to exert cognitive control. Students will be randomized in a 1) experimental group with biofeedback device and 2) experimental group without biofeedback device. Experimental groups will undergo an intervention that will strengthening cognitive control through mindfulness-based relaxation techniques. Outcome measures will include a multi-method approach collecting questionnaire, behavioral, and psycho-physiological indices of anxiety and self-control. The proposed study is innovative and has the potential to lead to more effective and cost-efficient types of intervention applications in the future.

Study Overview

• Status: Unknown
• Conditions: Anxiety
• Intervention / Treatment: Device: Wearable biofeedback; Behavioral: Relaxation Treatment

Detailed Description

Fourty participants will be tested in approximately 2 groups of 20 each. After individual first lab visits, participants in each cohort will be randomized into two groups: two experimental groups. The experimental group will subsequently attend a group-based relaxation treatment based on mindfulness meditation principles. After this intervention, one of the experimental groups will use the biofeedback device in the next two weeks, whereas the other experimental group will not. Both the biofeedback and No-Biofeedback group will receive texts on a daily basis.

During the lab session, participants will sign informed consent and fill out questionnaires. Questionnaires used will be:

• Difficulties in Emotion Regulation Scale
• State-Trait Anxiety Inventory
• Perceived Stress Scale
• Patient Health Questionnaire
• Sleep Scale from the Medical Outcomes Study
• and a constructed questionnaire about social support ( family & friends)

After that, participants are being hooked up to the ECG and Psychophysiological measures for a Stroop task (identify color of the word). The design will utilize a 1 min congruent task, followed by a 2 minute relaxation period, then a 1 min in-congruent task, followed up a 2 min relaxation period, then another 1 min congruent task, followed by a final 2 minute relaxation period. After that, participants will be deceived to think they will have to give a speech task in front of 5 evaluators. We will, however, inform participants of technical difficulties, resulting in our inability to follow through with the task, then again give the 2 minutes to regulate their physiology. Lab sessions, including set-up, should take about 45 minutes. After the testing section, all physiological measures will be removed and RAs will review meditation/ relaxation strategies with the participant. This relaxation training session will take about thirty minutes. After that, the biofeedback group will be given the biofeedback device as well as instruction on how to pair the device with their phone. After that, participants are free to leave.

The same lab procedures are being followed for the second lab visit after, approximately, two weeks without the relaxation session.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77840
      • Texas A&M Univeristy

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:

• students,
• self-reported chronic anxiety

Exclusion Criteria:

• Attention Deficit Hyperactive Disorder
• no major psychiatric disorder ( depression/anxiety okay)

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Experimental 1; Wearable biofeedback device + Relaxation Training	Device: Wearable biofeedback; Behavioral: Relaxation Treatment; group-based relaxation treatment based on mindfulness meditation principles
ACTIVE_COMPARATOR: Experimental 2; Relaxation Training only	Behavioral: Relaxation Treatment; group-based relaxation treatment based on mindfulness meditation principles

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
State/Trait Anxiety Scale	State Trait Anxiety Index (STAI); Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983	2 weeks
Difficulties in Emotion Regulation Scale	Difficulties in Emotion Regulation (DERS); Gratz & Roemer, 2004	2 weeks
Heart Rate	Using Biopac	2 weeks
Heart Rate Reactivity	Using Biopac	2 weeks
Respiratory Sinus Arrithmiya	Using Biopac	2 weeks
Perceived Stress Scale	Perceived Stress Scale; Cohen, Kamarack, & Mermelstein, 1983	2 weeks

Collaborators and Investigators

• Sponsor: Texas A&M University

Publications and helpful links

General Publications

• Lin B, Prickett C, Woltering S. Feasibility of using a biofeedback device in mindfulness training - a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Mar 24;7(1):84. doi: 10.1186/s40814-021-00807-1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2016
• Primary Completion (ANTICIPATED): July 1, 2019
• Study Completion (ANTICIPATED): July 1, 2019

Study Registration Dates

• First Submitted: July 13, 2016
• First Submitted That Met QC Criteria: July 14, 2016
• First Posted (ESTIMATE): July 19, 2016

Study Record Updates

• Last Update Posted (ACTUAL): April 26, 2018
• Last Update Submitted That Met QC Criteria: April 24, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Keywords: Biofeedback; Respiration; Self-Control
• Other Study ID Numbers: IRB2015-0786D