AnxietyNCT02837016
Biofeedback-aided Intervention for Self-regulation
A study testing Wearable biofeedback and Relaxation Treatment in people with Anxiety, run by Texas A&M University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety
- What is being tested?
- Wearable biofeedback and Relaxation Treatment
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2016to Jul 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- students,
- self-reported chronic anxiety
Who cannot join
- Attention Deficit Hyperactive Disorder
- no major psychiatric disorder ( depression/anxiety okay)
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Anxiety
- Being tested
- Wearable biofeedback, Relaxation Treatment
- Keywords
- Self-Control, Biofeedback, Respiration
- Medical subject headings
- Anxiety Disorders, Self-Control, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable biofeedbackDevice
Relaxation TreatmentBehavioural
group-based relaxation treatment based on mindfulness meditation principles
| Study group | Role | What they receive |
|---|---|---|
| Experimental 1 | Experimental | Wearable biofeedback device + Relaxation Training Receives: Device: Wearable biofeedback; Behavioral: Relaxation Treatment |
| Experimental 2 | Active comparator | Relaxation Training only Receives: Behavioral: Relaxation Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
State/Trait Anxiety Scale
State Trait Anxiety Index (STAI); Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983
Measured: 2 weeks
Difficulties in Emotion Regulation Scale
Difficulties in Emotion Regulation (DERS); Gratz \& Roemer, 2004
Measured: 2 weeks
Heart Rate
Using Biopac
Measured: 2 weeks
Heart Rate Reactivity
Using Biopac
Measured: 2 weeks
Respiratory Sinus Arrithmiya
Using Biopac
Measured: 2 weeks
Perceived Stress Scale
Perceived Stress Scale; Cohen, Kamarack, \& Mermelstein, 1983
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2016 (estimated)
- Study startJul 2016
- Primary completionJul 2019 (estimated)
- Study completionJul 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Steven Woltering, Texas A&M University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02837016
- Sponsor's protocol ID
- IRB2015-0786D
- Status last verified
- Apr 2018
- First submitted
- 13 Jul 2016
- Last updated
- 26 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
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.
PubMed 33762016
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biofeedback-aided Intervention for Self-regulation
- ClinicalTrials.gov ID
- NCT02837016
- Acronym / sponsor ID
- IRB2015-0786D
- Conditions
- Anxiety
- Keywords
- Self-Control, Biofeedback, Respiration
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Study start
- Jul 2016 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2019 (estimated)
- First posted
- 19 Jul 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental 1 | Experimental | Device: Wearable biofeedback, Behavioral: Relaxation TreatmentWearable biofeedback device + Relaxation Training |
| Experimental 2 | Active comparator | Behavioral: Relaxation TreatmentRelaxation Training only |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- students,
- self-reported chronic anxiety
Key exclusion criteria (2 listed)
- Attention Deficit Hyperactive Disorder
- no major psychiatric disorder ( depression/anxiety okay)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wearable biofeedback | Device | Experimental 1 |
| Relaxation Treatmentgroup-based relaxation treatment based on mindfulness meditation principles | Behavioural | Experimental 1, Experimental 2 |
Primary outcome
State/Trait Anxiety Scale
Time frame: 2 weeks
State Trait Anxiety Index (STAI); Spielberger, Gorsuch, Lushene, Vagg, \& Jacobs, 1983
Difficulties in Emotion Regulation Scale
Time frame: 2 weeks
Difficulties in Emotion Regulation (DERS); Gratz \& Roemer, 2004
Heart Rate
Time frame: 2 weeks
Using Biopac
Heart Rate Reactivity
Time frame: 2 weeks
Using Biopac
Respiratory Sinus Arrithmiya
Time frame: 2 weeks
Using Biopac
Perceived Stress Scale
Time frame: 2 weeks
Perceived Stress Scale; Cohen, Kamarack, \& Mermelstein, 1983
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2018.
- Derived from this study: PubMed 33762016Lin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable biofeedback and Relaxation Treatment in people with Anxiety, run by Texas A&M University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
State/Trait Anxiety Scale (time frame: 2 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02837016, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2018.