Biofeedback-aided Intervention for Self-regulation
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Anxiety, Anxiety |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/28/2018 |
| Start Date: | July 2016 |
| End Date: | July 2019 |
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.
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.
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.
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.
Inclusion Criteria:
- students,
- self-reported chronic anxiety
Exclusion Criteria:
- Attention Deficit Hyperactive Disorder
- no major psychiatric disorder ( depression/anxiety okay)
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