NCT02837016

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at below P25 for not_applicable anxiety

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable anxiety

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2016

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

July 13, 2016

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 19, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2019

Completed
Last Updated

April 26, 2018

Status Verified

April 1, 2018

Enrollment Period

3 years

First QC Date

July 13, 2016

Last Update Submit

April 24, 2018

Conditions

Anxiety

Keywords

Self-ControlBiofeedbackRespiration

Outcome Measures

Primary Outcomes (6)

  • 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

Study Arms (2)

Experimental 1

EXPERIMENTAL

Wearable biofeedback device + Relaxation Training

Device: Wearable biofeedbackBehavioral: Relaxation Treatment

Experimental 2

ACTIVE COMPARATOR

Relaxation Training only

Behavioral: Relaxation Treatment

Interventions

Wearable biofeedbackDEVICE
Experimental 1
Relaxation TreatmentBEHAVIORAL

group-based relaxation treatment based on mindfulness meditation principles

Experimental 1Experimental 2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • students,
  • self-reported chronic anxiety

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Texas A&M Univeristy

College Station, Texas, 77840, United States

Location

Related Publications (1)

  • 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.

    PMID: 33762016DERIVED

MeSH Terms

Conditions

Anxiety DisordersSelf-ControlRespiratory Aspiration

Condition Hierarchy (Ancestors)

Mental DisordersSocial BehaviorBehaviorRespiration DisordersRespiratory Tract DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 13, 2016

First Posted

July 19, 2016

Study Start

July 1, 2016

Primary Completion

July 1, 2019

Study Completion

July 1, 2019

Last Updated

April 26, 2018

Record last verified: 2018-04

Locations

US(1)