StressNCT02214264
Brief Trainings to Buffer Against Acute Stress Effects
A study testing Loving-Kindness meditation training, Breath Awareness meditation training and Gratitude in people with Stress, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the effectiveness of several brief trainings based on contemplative practices and positive psychology to buffer against the negative effects that acute stress has on behavior and cognitive abilities. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress
- What is being tested?
- Loving-Kindness meditation training, Breath Awareness meditation training and Gratitude
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 172 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to May 2015
- 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
- undergraduate psychology recruitment pool
Who cannot join
- non-native English speakers, pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin-Madison
Madison, Wisconsin, 53705
About this study
The purpose of this study is to evaluate and compare the effectiveness of several brief trainings based on contemplative practices and positive psychology to buffer against the negative effects that acute stress has on behavior and cognitive abilities. The investigators hypothesize that training will buffer against negative effects of acute stress.
Read the detailed description
Participants will be taught a stress reducing training (breath awareness, loving kindness practice, gratitude exercise) and will practice using this technique for 10-15 minutes. Following this, all participants will undergo the Cold Pressor Task (CPT) for up to 3 minutes.
Before and after these tasks, participant data related to attention, working memory, self regulation, affect, and prosociality will be collected.
- Conditions
- Stress
- Being tested
- Loving-Kindness meditation training, Breath Awareness meditation training, Gratitude, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Loving-Kindness meditation trainingBehavioural
Participants undergo training for approximately 12 minutes. Training involves guided reflections and intentions related to feeling loving-kindness towards the self and others.
Breath Awareness meditation trainingBehavioural
Participants undergo training for approximately 12 minutes. Training involves guided awareness focused on sensations of breathing.
GratitudeBehavioural
Participants undergo training for approximately 12 minutes. Training involves reflections of gratitude for people, events, and things in one's life.
ControlBehavioural
Participants will write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Loving-Kindness training | Experimental | Participants receive Loving-Kindness meditation training for approximately 12 minutes. Receives: Behavioral: Loving-Kindness meditation training |
| Breath Awareness training | Experimental | Participants receive Breath Awareness meditation training for approximately 12 minutes. Receives: Behavioral: Breath Awareness meditation training |
| Gratitude training | Experimental | Participants will receive Gratitude training for approximately 12 minutes. Receives: Behavioral: Gratitude |
| Control | Other | Participants write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes. Receives: Behavioral: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline performance on Operational Span task
Measured: Baseline and 10 minutes following post stress induction
Change from baseline in time spent on hand grip self regulation task
Measured: Baseline and 30 minutes post stress induction
Change from baseline on likeability ratings of neutral stimuli
Measured: Baseline and 1 minute post stress induction
Number of trials completed in optional Generosity task
Measured: 40 minutes post stress induction
Positive and Negative Affect Schedule ratings at baseline
Measured: Baseline
Positive and Negative Affect Schedule ratings after pre-test measures
Measured: 2 minutes before training
Positive and Negative Affect Schedule ratings after training
Measured: 1 minute after training
Positive and Negative Affect Schedule ratings after stress induction
Measured: 1 minute after stress induction
Positive and Negative Affect Schedule ratings after post-test
Measured: 1 minute after post-test measures
Implicit Positive and Negative Affect Test at baseline
Measured: Baseline
Implicit Positive and Negative Affect Test after pre-test measures
Measured: 2 minutes before training
Implicit Positive and Negative Affect Test after training
Measured: 1 minute after training
Implicit Positive and Negative Affect Test after stress induction
Measured: 1 minute after stress induction
Implicit Positive and Negative Affect Test after post-test
Measured: 1 minute after post-test
Secondary outcomes (1)
Participant interest in participating in future training
Interest will be rated using a visual analog scale.
Measured: 40 minutes post stress induction
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionMay 2015
- Study completionMay 2015
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 StressStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 172 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stacey Schaefer, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02214264
- Sponsor's protocol ID
- 2014-0572
- Other IDs
- MLK2014
- Status last verified
- May 2019
- First submitted
- 31 Jul 2014
- Last updated
- 23 May 2019
- Results posted
- No
- Data monitoring committee
- No
Publications
Goldberg SB, Flook L, Hirshberg MJ, Davidson RJ, Schaefer SM. Brief breath awareness training yields poorer working memory performance in the context of acute stress. Cogn Emot. 2021 Aug;35(5):1009-1017. doi: 10.1080/02699931.2021.1878113. Epub 2021 Jan 29.
PubMed 33509056
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Trainings to Buffer Against Acute Stress Effects
- ClinicalTrials.gov ID
- NCT02214264
- Acronym / sponsor ID
- 2014-0572
- Conditions
- Stress
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 172 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Oct 2014 (actual)
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 12 Aug 2014 (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 purpose of this study is to evaluate and compare the effectiveness of several brief trainings based on contemplative practices and positive psychology to buffer against the negative effects that acute stress has on behavior and cognitive abilities. The investigators hypothesize that training will buffer against negative effects of acute stress.
Detailed description
Participants will be taught a stress reducing training (breath awareness, loving kindness practice, gratitude exercise) and will practice using this technique for 10-15 minutes. Following this, all participants will undergo the Cold Pressor Task (CPT) for up to 3 minutes.
Before and after these tasks, participant data related to attention, working memory, self regulation, affect, and prosociality will be collected.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Loving-Kindness training | Experimental | Behavioral: Loving-Kindness meditation trainingParticipants receive Loving-Kindness meditation training for approximately 12 minutes. |
| Breath Awareness training | Experimental | Behavioral: Breath Awareness meditation trainingParticipants receive Breath Awareness meditation training for approximately 12 minutes. |
| Gratitude training | Experimental | Behavioral: GratitudeParticipants will receive Gratitude training for approximately 12 minutes. |
| Control | Other | Behavioral: ControlParticipants write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergraduate psychology recruitment pool
Key exclusion criteria (1 listed)
- non-native English speakers, pregnant women
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 |
|---|---|---|
| Loving-Kindness meditation trainingParticipants undergo training for approximately 12 minutes. Training involves guided reflections and intentions related to feeling loving-kindness towards the self and others. | Behavioural | Loving-Kindness training |
| Breath Awareness meditation trainingParticipants undergo training for approximately 12 minutes. Training involves guided awareness focused on sensations of breathing. | Behavioural | Breath Awareness training |
| GratitudeParticipants undergo training for approximately 12 minutes. Training involves reflections of gratitude for people, events, and things in one's life. | Behavioural | Gratitude training |
| ControlParticipants will write and then think about the physical space in which they live (i.e., their home) for approximately 12 minutes. | Behavioural | Control |
Primary outcome
Change from baseline performance on Operational Span task
Time frame: Baseline and 10 minutes following post stress induction
Change from baseline in time spent on hand grip self regulation task
Time frame: Baseline and 30 minutes post stress induction
Change from baseline on likeability ratings of neutral stimuli
Time frame: Baseline and 1 minute post stress induction
Number of trials completed in optional Generosity task
Time frame: 40 minutes post stress induction
Positive and Negative Affect Schedule ratings at baseline
Time frame: Baseline
Positive and Negative Affect Schedule ratings after pre-test measures
Time frame: 2 minutes before training
Positive and Negative Affect Schedule ratings after training
Time frame: 1 minute after training
Positive and Negative Affect Schedule ratings after stress induction
Time frame: 1 minute after stress induction
Positive and Negative Affect Schedule ratings after post-test
Time frame: 1 minute after post-test measures
Implicit Positive and Negative Affect Test at baseline
Time frame: Baseline
Implicit Positive and Negative Affect Test after pre-test measures
Time frame: 2 minutes before training
Implicit Positive and Negative Affect Test after training
Time frame: 1 minute after training
Implicit Positive and Negative Affect Test after stress induction
Time frame: 1 minute after stress induction
Implicit Positive and Negative Affect Test after post-test
Time frame: 1 minute after post-test
1 secondary outcome
Participant interest in participating in future training
Time frame: 40 minutes post stress induction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 May 2019.
- Derived from this study: PubMed 33509056Goldberg SB, Flook L, Hirshberg MJ, Davidson RJ, Schaefer SM. Brief breath awareness training yields poorer working memory performance in the context of acute stress. Cogn Emot. 2021 Aug;35(5):1009-1017. doi: 10.1080/02699931.2021.1878113. Epub 2021 Jan 29.
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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.
Stacey Schaefer principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Loving-Kindness meditation training, Breath Awareness meditation training and Gratitude in people with Stress, run by University of Wisconsin, Madison 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 23 May 2019. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change from baseline performance on Operational Span task (time frame: Baseline and 10 minutes following post stress induction). The study lists 14 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 NCT02214264, 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 23 May 2019.