StressNCT04740229
Moderate-intensity Flow-based Yoga Effects on Cognition and Stress
A study testing Yoga in people with Stress and Psychological, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial summary
The purpose of this study is to test the efficacy of an 8-week, remotely-delivered, flow-based and moderate-intensity yoga intervention (vs. waitlist control), on stress and cognitive functioning. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological
- What is being tested?
- Yoga
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Feb 2021to 30 Aug 2021
- 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 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 64 years.
- Full-time working adults, defined as working >35 hrs/week in any industry, and not currently enrolled as a full-time student.
- Presence of at least three symptoms of stress or anxiety as measured by the symptom checklist from the Diagnostic and Statistical Manual VI.
- Low active, i.e. participating in physical activity and/or mind-body activities such as yoga and tai-chi less than 3 times/week for 30 minutes, in the last three months.
- Ability to exercise at a moderate intensity, and perform movements including sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up without difficulty.
- No engagement in mindful activities, such as meditation, or brain training games, for greater than 3 times/week for 30 minutes, in the last three months.
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- Currently not involved in any other research study or structured program related to physical activity, mind-body activities, or brain training games.
- Access to a yoga mat, and a smartphone with a data plan or access to WiFi, on which an application could be downloaded.
- Access to a laptop or desktop with an attached keyboard
- Willingness to be randomized to one of two conditions
Who cannot join
- Age below 18 years or above 64 years
- Students or non full-time working adults, such as part-time working adults
- Presence of two or less symptoms of stress or anxiety as measured by the symptom checklist from the Diagnostic and Statistical Manual VI.
- Engaging in high levels of physical activity (≥ 30 minutes, two or more times/week, for the last three months) and/or a regular practitioner of Yoga or mind-body activities such as tai-chi and mindfulness meditation (≥ 30 minutes, two or more times/week, for the last three months) and/or a certified yoga teacher.
- Mobility impairment restricting ability to engage in moderate intensity activity.
- Engagement in mindful activities, such as meditation, or brain training games, for greater than 3 times/week for 30 minutes, in the last three months
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- Currently involved in research study or structured program related to physical activity, mind-body activities, or brain training games
- No access to yoga mat or a smartphone with data or WiFi, as well as refusal to download a health application on their smartphone.
- Refusal or unwillingness to be randomized into either of the conditions.
- Having any of the following medical conditions, including risk of seizure, psychiatric and/or neurological disorders, or diagnosed hypertension or blood pressure of 200/105 or more.
- Score of >1 on the Physical Activity Readiness Questionnaire.
- Unavailable for >one week in the 10-week study
- Prior yoga experience in the last 10 years. i.e. those who have engaged in 50 consecutive weeks of yoga sessions each lasting 60 minutes, without missing 12 weeks or more
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
About this study
Official title: Testing the Impact of Flow-based, Moderate-intensity Yoga on Executive Functioning and Stress Among Low Active Working Adults Having Symptoms of Stress
The purpose of this study is to test the efficacy of an 8-week, remotely-delivered, flow-based and moderate-intensity yoga intervention (vs. waitlist control), on stress and cognitive functioning. Participants will include individuals who are full-time working adults between the ages of 18 and 64, and currently experiencing symptoms of psychosocial stress or anxiety.
Read the detailed description
Participants who pass a telephone screening, electronically sign our informed consent agreement, and complete baseline testing, will be randomized to one of two groups: yoga intervention or a waitlist control group. Before and after the 8-week intervention, participants will complete psychosocial questionnaires and computerized cognitive testing. The remote intervention will be delivered via Google Meet and will be led by a certified yoga instructor. During the course of the intervention, participants will be wearing a consumer grade accelerometer to track heart rate during yoga sessions and physical activity during the 8 weeks.
- Conditions
- Stress, Psychological
- Being tested
- Yoga
- Keywords
- sun salutations, longitudinal, remote, cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
YogaBehavioural
Moderate-intensity flow-based yoga movements, breathing, and relaxation for 50 minutes, 3 times per week, for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Moderate-intensity flow-based Yoga | Experimental | The intervention will consist of participants engaging in a progressive series of moderate-intensity, flow-based yoga poses, along with breathing and relaxation, for eight weeks. The intervention will be titrated in terms of supervision, with first two weeks being completely supervised, followed by partial supervision for three weeks, and three weeks of unsupervised sessions. The sessions will be ~50 minutes long, 3 times/week. All supervised sessions will be conducted online through Google Meet (GM), which is a live video interaction platform. Videos will be provided to guide unsupervised sessions. Sessions will be led by a certified yoga instructor. An orientation will be provided in the first week, given that the participants will have no or minimal experience with yoga. The intervention will consist of basic sun salutations of hatha yoga sun salutation A, sun salutation B and flow sequences, and breathing exercises, and relaxation. Receives: Behavioral: Yoga |
| Waitlist control | No intervention | Participants in this group will not receive the 8-week intervention during the course of the study, and will be asked to engage in their regular activities. They will be asked to not start any new activities during the study period. After they complete the study, they will be provided with the same intervention (live instruction, feedback and supportive videos). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perceived Stress
The Perceived Stress Scale (PSS), developed by Cohen, Kamarck, and Mermelstein (1983) will be used to measure perceived psychosocial stress. The PSS is a 10-item scale that measures the extent to which situations are perceived as stressful. Responses range from 0 (Never) to 4 (Very often) and higher scores indicate a higher level of perceived stress. The Brief Job Stress Questionnaire, developed by Kawada and Otsuka (2011), is a 15-item scale measuring job stress. It focuses on the evaluation of job demands, job control, job support, and degree of job satisfaction. Responses range from 1 (Agree) to 4 (Disagree) and higher scores indicate a lower level of stress.
Measured: Change from baseline at 8 weeks
Secondary outcomes (4)
Task switching paradigm
This measures cognitive flexibility, i.e. a participant's ability to adapt quickly to changing rules and the cost associated with it. In this task, participants have to characterize the picture presented according to shape or color, with a switch in the rules occurring every two tasks. Participants are cued to the rule before the stimulus is presented. Reaction time and accuracy will be recorded, with lower reaction time and higher accuracy indicating better performance. Participants will complete 40 trials.
Measured: Change from baseline at 8 weeks
Digit span forward and backward
This is a measure of the storage and manipulation capacity of working memory. The participant will be shown a series of digits presented on PowerPoint, through screen sharing. The minimum length of digits presented is 3 (e.g., 638) and the maximum length is 9 (e.g., 628295702). In the forward task, participants will be asked to recall the digits exactly as they were presented, while in the backward task, they will have to recall them in the reverse order. Digit-span backward is the more complex task of the two. Accuracy will recorded, with higher accuracy indicating better performance.
Measured: Change from baseline at 8 weeks
Digit symbol substitution test (DSST)
DSST is a task measuring processing speed. Participants will be shown a code-key in which every digit matches a particular symbol. Then, they will be shown a symbol on the screen and participants will have to say the corresponding digit aloud, as quickly and accurately as possible. Participants are given 90 seconds to complete as many digit-symbol pairings as possible. The number of accurate pairings will be recorded, with a higher score indicating better performance. This task will be completed by showing the symbols to participants via screen sharing.
Measured: Change from baseline at 8 weeks
Stroop task
Stroop task measures response inhibition or response interference control. Participants will be shown a series of word colors that are either congruent or incongruent with the color of the word itself. The participant will be asked to respond to the color of the word and not the word itself. Responses are made with the keyboard. The incongruent condition is the more difficult condition of the two. Reaction time is recorded and a cost score is calculated, with shorter cost scores indicating better performance.
Measured: Change from baseline at 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2021
- Study start10 Feb 2021
- Primary completion30 Aug 2021
- Study completion30 Aug 2021
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.
- 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
- Model description
- Randomized Controlled Trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sean Mullen, University of Illinois at Urbana-Champaign
- Investigators
- Sean P Mullen, PhD, Principal investigator, University of Illinois, Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04740229
- Sponsor's protocol ID
- 21584
- Status last verified
- Jun 2022
- First submitted
- 1 Feb 2021
- Last updated
- 6 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data for primary and secondary outcome measures will be made available
Publications
Phansikar M, Gothe N, Hernandez R, Lara-Cinisomo S, Mullen SP. Feasibility and impact of a remote moderate-intensity yoga intervention on stress and executive functioning in working adults: a randomized controlled trial. J Behav Med. 2023 Oct;46(5):720-731. doi: 10.1007/s10865-022-00385-4. Epub 2023 Feb 8.
PubMed 36754937
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing the Impact of Flow-based, Moderate-intensity Yoga on Executive Functioning and Stress Among Low Active Working Adults Having Symptoms of Stress
- ClinicalTrials.gov ID
- NCT04740229
- Acronym / sponsor ID
- 21584
- Conditions
- Stress, Psychological
- Keywords
- sun salutations, longitudinal, remote, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Study start
- 10 Feb 2021 (actual)
- Primary completion
- 30 Aug 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 5 Feb 2021 (actual)
- 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 test the efficacy of an 8-week, remotely-delivered, flow-based and moderate-intensity yoga intervention (vs. waitlist control), on stress and cognitive functioning. Participants will include individuals who are full-time working adults between the ages of 18 and 64, and currently experiencing symptoms of psychosocial stress or anxiety.
Detailed description
Participants who pass a telephone screening, electronically sign our informed consent agreement, and complete baseline testing, will be randomized to one of two groups: yoga intervention or a waitlist control group. Before and after the 8-week intervention, participants will complete psychosocial questionnaires and computerized cognitive testing. The remote intervention will be delivered via Google Meet and will be led by a certified yoga instructor. During the course of the intervention, participants will be wearing a consumer grade accelerometer to track heart rate during yoga sessions and physical activity during the 8 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Moderate-intensity flow-based Yoga | Experimental | Behavioral: YogaThe intervention will consist of participants engaging in a progressive series of moderate-intensity, flow-based yoga poses, along with breathing and relaxation, for eight weeks. The intervention will be titrated in terms of supervision, with first two weeks being completely supervised, followed by partial supervision for three weeks, and three weeks of unsupervised sessions. The sessions will be ~50 minutes long, 3 times/week. All supervised sessions will be conducted online through Google Meet (GM), which is a live video interaction platform. Videos will be provided to guide unsupervised sessions. Sessions will be led by a certified yoga instructor. An orientation will be provided in the first week, given that the participants will have no or minimal experience with yoga. The intervention will consist of basic sun salutations of hatha yoga sun salutation A, sun salutation B and flow sequences, and breathing exercises, and relaxation. |
| Waitlist control | No intervention | –Participants in this group will not receive the 8-week intervention during the course of the study, and will be asked to engage in their regular activities. They will be asked to not start any new activities during the study period. After they complete the study, they will be provided with the same intervention (live instruction, feedback and supportive videos). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age between 18 and 64 years.
- Full-time working adults, defined as working >35 hrs/week in any industry, and not currently enrolled as a full-time student.
- Presence of at least three symptoms of stress or anxiety as measured by the symptom checklist from the Diagnostic and Statistical Manual VI.
- Low active, i.e. participating in physical activity and/or mind-body activities such as yoga and tai-chi less than 3 times/week for 30 minutes, in the last three months.
- Ability to exercise at a moderate intensity, and perform movements including sitting, standing, kicking, pulling, pushing, bending one's elbows, bending the body forward, bending one's knees, lying down and getting up without difficulty.
Key exclusion criteria (13 listed)
- Age below 18 years or above 64 years
- Students or non full-time working adults, such as part-time working adults
- Presence of two or less symptoms of stress or anxiety as measured by the symptom checklist from the Diagnostic and Statistical Manual VI.
- Engaging in high levels of physical activity (≥ 30 minutes, two or more times/week, for the last three months) and/or a regular practitioner of Yoga or mind-body activities such as tai-chi and mindfulness meditation (≥ 30 minutes, two or more times/week, for the last three months) and/or a certified yoga teacher.
- Mobility impairment restricting ability to engage in moderate intensity activity.
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 |
|---|---|---|
| YogaModerate-intensity flow-based yoga movements, breathing, and relaxation for 50 minutes, 3 times per week, for 8 weeks | Behavioural | Moderate-intensity flow-based Yoga |
Primary outcome
Perceived Stress
Time frame: Change from baseline at 8 weeks
The Perceived Stress Scale (PSS), developed by Cohen, Kamarck, and Mermelstein (1983) will be used to measure perceived psychosocial stress. The PSS is a 10-item scale that measures the extent to which situations are perceived as stressful. Responses range from 0 (Never) to 4 (Very often) and higher scores indicate a higher level of perceived stress. The Brief Job Stress Questionnaire, developed by Kawada and Otsuka (2011), is a 15-item scale measuring job stress. It focuses on the evaluation of job demands, job control, job support, and degree of job satisfaction. Responses range from 1 (Agree) to 4 (Disagree) and higher scores indicate a lower level of stress.
4 secondary outcomes
Task switching paradigm
Time frame: Change from baseline at 8 weeks
Digit span forward and backward
Time frame: Change from baseline at 8 weeks
Digit symbol substitution test (DSST)
Time frame: Change from baseline at 8 weeks
Stroop task
Time frame: Change from baseline at 8 weeks
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 6 Jun 2022.
- Derived from this study: PubMed 36754937Phansikar M, Gothe N, Hernandez R, Lara-Cinisomo S, Mullen SP. Feasibility and impact of a remote moderate-intensity yoga intervention on stress and executive functioning in working adults: a randomized controlled trial. J Behav Med. 2023 Oct;46(5):720-731. doi: 10.1007/s10865-022-00385-4. Epub 2023 Feb 8.
- Full-time working adults interested in participating in the study should fill out the interest survey at this linkLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified data for primary and secondary outcome measures will be made available
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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.
Sean P Mullen, PhD principal investigator
University of Illinois, Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga in people with Stress and Psychological, run by University of Illinois at Urbana-Champaign 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 10 inclusion and 13 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 6 Jun 2022. 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?
Perceived Stress (time frame: Change from baseline at 8 weeks). 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 NCT04740229, 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 6 Jun 2022.