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Biofeedback-aided Intervention for Self-regulation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02837016
Recruitment Status : Unknown
Verified April 2018 by Steven Woltering, Texas A&M University.
Recruitment status was:  Active, not recruiting
First Posted : July 19, 2016
Last Update Posted : April 26, 2018
Information provided by (Responsible Party):
Steven Woltering, Texas A&M University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Anxiety Device: Wearable biofeedback Behavioral: Relaxation Treatment Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : July 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

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

Primary Outcome Measures :
  1. State/Trait Anxiety Scale [ Time Frame: 2 weeks ]
    State Trait Anxiety Index (STAI); Spielberger, Gorsuch, Lushene, Vagg, & Jacobs, 1983

  2. Difficulties in Emotion Regulation Scale [ Time Frame: 2 weeks ]
    Difficulties in Emotion Regulation (DERS); Gratz & Roemer, 2004

  3. Heart Rate [ Time Frame: 2 weeks ]
    Using Biopac

  4. Heart Rate Reactivity [ Time Frame: 2 weeks ]
    Using Biopac

  5. Respiratory Sinus Arrithmiya [ Time Frame: 2 weeks ]
    Using Biopac

  6. Perceived Stress Scale [ Time Frame: 2 weeks ]
    Perceived Stress Scale; Cohen, Kamarack, & Mermelstein, 1983

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • students,
  • self-reported chronic anxiety

Exclusion Criteria:

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02837016

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United States, Texas
Texas A&M Univeristy
College Station, Texas, United States, 77840
Sponsors and Collaborators
Texas A&M University
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Responsible Party: Steven Woltering, Assistant Professor, Texas A&M University Identifier: NCT02837016    
Other Study ID Numbers: IRB2015-0786D
First Posted: July 19, 2016    Key Record Dates
Last Update Posted: April 26, 2018
Last Verified: April 2018
Keywords provided by Steven Woltering, Texas A&M University: