Social DiscriminationREDUCENCT05131360
Reducing Daily Stress Among Sexual and Gender Minorities
A study testing Introduction Only, Purpose Only and Connection Only in people with Social Discrimination and Sexual and Gender Minorities, run by New York University at 1 site in United States.
Trial summary
The purpose of this study is to identify which mindfulness technique, or combination of mindfulness techniques, is most effective at mediating or eliminating stress in emerging adults who are sexual and gender as well as racial or ethnic minorities. Read more about this study
- Who is it for?
- Ages 18 to 29 yearsHealthy volunteers can take part
- Conditions the study is for
- Social Discrimination, Sexual and Gender Minorities, Mindfulness
- What is being tested?
- Introduction Only, Purpose Only and Connection Only
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2021to 30 Mar 2022
- 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 29 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Between 18-29 years
- Must identify as a sexual minority (e.g. gay, bisexual, sexually fluid, etc.)
- Must identify as an underrepresented racial/ethnic minority
- Have an active cell phone service and be able to access the cell phone 7 days a week between 6 p.m. and 6 a.m. the next morning
- Be willing and able to receive up to 6 text messages per day
- Have consistent Internet access 7 days a week between 6 p.m. and 6 a.m.
- Can understand, read, and speak English
- Willing to provide written informed consent.
Who cannot join
- Not between 18-29 years
- Does not identify as a sexual minority (e.g. gay, bisexual, sexually fluid, etc.)
- Does not identify as an underrepresented racial/ethnic minority
- Does not have an active cell phone service and or ability to access the cell phone 7 days a week between 6 p.m. and 6 a.m. the next morning
- Not willing and able to receive up to 6 text messages per day
- Does not have consistent Internet access 7 days a week between 6 p.m. and 6 a.m.
- Does not have the ability to understand, read, and speak English
- Not willing to provide written informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
New York University School of Global Public Health
New York, New York, 10003
Stephanie H Cook, DrPH, 212-992-5635, sc5810@nyu.edu
Erica P Wood, MPH, 832-776-1095, ew71@nyu.edu
About this study
Official title: Reducing Daily Stress Among Sexual and Gender Minorities (the REDUCE Study)
The purpose of this study is to identify which mindfulness technique, or combination of mindfulness techniques, is most effective at mediating or eliminating stress in emerging adults who are sexual and gender as well as racial or ethnic minorities. Participants will be randomly assigned to one of eight conditions that are composed of the mindfulness techniques of Awareness, Purpose, and Connection.
Read the detailed description
Underrepresented racial/ethnic sexual and gender minorities (SGM) aged 18-29 will be recruited via convenience sampling from social media websites (e.g. Facebook, Instagram) and listservs from NYU student groups and through LGBT community partners. Interested persons who screen eligible through the study's online eligibility screener will be asked to provide their phone number and/or email address to be contacted by a research assistant. An online meeting via Zoom will then be scheduled to confirm eligibility, provide additional information concerning study parameters. The online meeting will be between the research assistant and a single participant. The meeting will take between 10 to 15 minutes depending on the questions individuals may have. The meeting will be an informational assessment to assure that the individual can effectively use and have access to the materials used in the study, the online surveys/assessments, and interventions.
After providing online informed consent through REDCap, the participant will be randomized into one of the 8 mindfulness conditions, complete a 30-minute baseline survey via REDCap, and be provided with training on study protocols. Participants will engage in the study of a 5-day period (starting after the baseline survey). Participants will engage in one of 8 interventions, depending on randomization, in which participants will engage with mindfulness activities each night for a total of 5 nights which is expected to take 10-20 minutes per day (the exception to this is the control condition who only receives an introduction to mindfulness on day 1). In addition, each night over the 5-day period, participants will be sent a REDCap survey to complete a "nightly diary" which will take about 5 minutes to complete.
After completion of the 5-day protocol, participants will be scheduled for an online Zoom meeting where participants will engage in a 30-40 minute debrief interview and be renumerated. The Zoom meetings will be between a research assistant and a single participant. Lastly, in order to improve retention, RA's will perform check-in calls twice during the 5-day daily diary period.
The interventions will be administered using the multiphase optimization strategy (MOST). The participants will be randomized to at least one of the 3 intervention components of Awareness, Purpose, and Connection for this optimization study, which make up the 8 conditions. Each of these components is known to be effective in reducing stress and promoting well-being among populations that experience a high rate of discrimination (e.g., SGM). The three components are administered via the Healthy Minds Program (HMP), which is a smartphone app-based mindfulness intervention developed through the research of Dr. Richard Davidson and his team at the University of Wisconsin-Madison's Center for Healthy Minds in affiliation with the non-profit Healthy Minds Innovations (HMI). The app provides an average of 10-minute meditations that can be completed while sitting, walking, or exercising that focus on the modules of Awareness, Purpose, and Connection. Participants will log into the app and listen to the meditations that correspond to their selected randomization on each of the 5 days. The app's methodology aligns with constituents of psychological well-being that are trainable and measurable as evidenced by the Center for Healthy Minds: Awareness, Purpose, and Connection. The components are as follows: 1) Awareness through meditation promotes self-awareness, reducing the mind's ability to be distracted and instead be present at the moment. Awareness promotes well-being by bringing attention to the present moment, not allowing the mind to wander to negative thoughts that cause stress; 2) Purpose through meditation promotes mindfulness of one's thoughts and feelings in the present moment and encourages compassion with oneself and positive reappraisal; 3) Connection through meditation supports empathy, compassion, and kindness in daily activities. By shifting to this positive mindset, individuals are able to cultivate social support networks which research has found to decrease the risk for depression.
- Being tested
- Introduction Only, Purpose Only, Connection Only, Connection and Purpose, Awareness Only
- Keywords
- Social stress, Stress from discrimination, Mindfulness, Anxiety, Depression, Sexual and gender minorities
- Medical subject headings
- Social Discrimination, Coitus, Anxiety Disorders, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Introduction OnlyBehavioural
This is the placebo condition in which participants engage in one day of introductory mindfulness activities.
Purpose OnlyBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of purpose-based mindfulness techniques.
Connection OnlyBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of connection-based mindfulness techniques.
Connection and PurposeBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of connection and purpose-based mindfulness techniques.
Awareness OnlyBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness-based mindfulness techniques.
Awareness and PurposeBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and purpose-based mindfulness techniques.
Awareness, Purpose, and ConnectionBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness, connection, and purpose-based mindfulness techniques
Awareness and ConnectionBehavioural
Participants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and connection-based mindfulness techniques.
| Study group | Role | What they receive |
|---|---|---|
| Introduction Only | Placebo comparator | This is the control; participants only partake in one day's worth of the introduction or foundational mindfulness activities on the HMI app. Receives: Behavioral: Introduction Only |
| Purpose Only | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform purpose-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Purpose Only |
| Connection Only | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform connection-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Connection Only |
| Connection and Purpose | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform connection and purpose-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Connection and Purpose |
| Awareness Only | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform awareness-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Awareness Only |
| Awareness and Purpose | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform awareness and connection-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Awareness and Purpose |
| Awareness, Purpose, and Connection | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform connection, awareness, and purpose-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Awareness, Purpose, and Connection |
| Awareness and Connection | Experimental | Participants partake in the introduction or foundational mindfulness for one day and then perform awareness and connection-based mindfulness techniques for 5 days on the HMI app. Receives: Behavioral: Awareness and Connection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Perceived Stress on the Perceived Stress Scale at Day 5
The primary outcome for this study is change in perceived stress as measured by the Perceived Stress Scale from baseline to Day 5 among all study participants.
Measured: Baseline through study completion, up to one year
Change from Baseline in Satisfaction with Life on the Satisfaction with Life Scale at Day 5
The primary outcome for this study is change in perceived satisfaction with life as measured by the Satisfaction with Life Scale from baseline to Day 5 among all study participants.
Measured: Baseline through study completion, up to one year
Secondary outcomes (1)
Optimized Intervention Package
An optimal intervention combination will be determined with the primary outcomes of perceived stress (as measured through the Perceived Stress Scale) and satisfaction with life (as measured through the Satisfaction with Life Scale) by looking at changes in mean perceived stress and satisfaction with life across all intervention categories.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start1 Jan 2021
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Social DiscriminationStudies of the same condition, open and under way.
- More trials run by New York UniversityThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie H Cook, DrPH, Principal investigator, New York University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131360
- Sponsor's protocol ID
- IRB-FY2020-4338
- Acronym
- REDUCE
- Status last verified
- Jul 2021
- First submitted
- 5 Oct 2021
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: N/A (not to be shared with other researchers)
Publications
Cook SH, Wood EP, Rodrigues M, Delorme M, Tatar R, Goldberg SB, Javdani S, Godfrey E. A Daily Digital Mindfulness Meditation to Reduce Stress from Discrimination Among Racially Diverse Sexual and Gender Minorities: Preparation Phase of the Multi-Phase Optimization Strategy (MOST). Mindfulness (N Y). 2026 May 21:10.1007/s12671-026-02874-y. doi: 10.1007/s12671-026-02874-y. Online ahead of print.
PubMed 42524134Cook SH, Wood EP, Mirin N, Bandel M, Delorme M, Gad L, Jayakar O, Mustafa Z, Tatar R, Javdani S, Godfrey E. A Mindfulness-Based Intervention to Alleviate Stress From Discrimination Among Young Sexual and Gender Minorities of Color: Protocol for a Pilot Optimization Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e35593. doi: 10.2196/35593.
PubMed 34928237
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Daily Stress Among Sexual and Gender Minorities (the REDUCE Study)
- ClinicalTrials.gov ID
- NCT05131360
- Acronym / sponsor ID
- REDUCE / IRB-FY2020-4338
- Keywords
- Social stress, Stress from discrimination, Mindfulness, Anxiety, Depression, Sexual and gender minorities
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- New York UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Mar 2022 (estimated)
- First posted
- 23 Nov 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 identify which mindfulness technique, or combination of mindfulness techniques, is most effective at mediating or eliminating stress in emerging adults who are sexual and gender as well as racial or ethnic minorities. Participants will be randomly assigned to one of eight conditions that are composed of the mindfulness techniques of Awareness, Purpose, and Connection.
Detailed description
Underrepresented racial/ethnic sexual and gender minorities (SGM) aged 18-29 will be recruited via convenience sampling from social media websites (e.g. Facebook, Instagram) and listservs from NYU student groups and through LGBT community partners. Interested persons who screen eligible through the study's online eligibility screener will be asked to provide their phone number and/or email address to be contacted by a research assistant. An online meeting via Zoom will then be scheduled to confirm eligibility, provide additional information concerning study parameters. The online meeting will be between the research assistant and a single participant. The meeting will take between 10 to 15 minutes depending on the questions individuals may have. The meeting will be an informational assessment to assure that the individual can effectively use and have access to the materials used in the study, the online surveys/assessments, and interventions.
After providing online informed consent through REDCap, the participant will be randomized into one of the 8 mindfulness conditions, complete a 30-minute baseline survey via REDCap, and be provided with training on study protocols. Participants will engage in the study of a 5-day period (starting after the baseline survey). Participants will engage in one of 8 interventions, depending on randomization, in which participants will engage with mindfulness activities each night for a total of 5 nights which is expected to take 10-20 minutes per day (the exception to this is the control condition who only receives an introduction to mindfulness on day 1). In addition, each night over the 5-day period, participants will be sent a REDCap survey to complete a "nightly diary" which will take about 5 minutes to complete.
After completion of the 5-day protocol, participants will be scheduled for an online Zoom meeting where participants will engage in a 30-40 minute debrief interview and be renumerated. The Zoom meetings will be between a research assistant and a single participant. Lastly, in order to improve retention, RA's will perform check-in calls twice during the 5-day daily diary period.
The interventions will be administered using the multiphase optimization strategy (MOST). The participants will be randomized to at least one of the 3 intervention components of Awareness, Purpose, and Connection for this optimization study, which make up the 8 conditions. Each of these components is known to be effective in reducing stress and promoting well-being among populations that experience a high rate of discrimination (e.g., SGM). The three components are administered via the Healthy Minds Program (HMP), which is a smartphone app-based mindfulness intervention developed through the research of Dr. Richard Davidson and his team at the University of Wisconsin-Madison's Center for Healthy Minds in affiliation with the non-profit Healthy Minds Innovations (HMI). The app provides an average of 10-minute meditations that can be completed while sitting, walking, or exercising that focus on the modules of Awareness, Purpose, and Connection. Participants will log into the app and listen to the meditations that correspond to their selected randomization on each of the 5 days. The app's methodology aligns with constituents of psychological well-being that are trainable and measurable as evidenced by the Center for Healthy Minds: Awareness, Purpose, and Connection. The components are as follows: 1) Awareness through meditation promotes self-awareness, reducing the mind's ability to be distracted and instead be present at the moment. Awareness promotes well-being by bringing attention to the present moment, not allowing the mind to wander to negative thoughts that cause stress; 2) Purpose through meditation promotes mindfulness of one's thoughts and feelings in the present moment and encourages compassion with oneself and positive reappraisal; 3) Connection through meditation supports empathy, compassion, and kindness in daily activities. By shifting to this positive mindset, individuals are able to cultivate social support networks which research has found to decrease the risk for depression.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| Introduction Only | Placebo comparator | Behavioral: Introduction OnlyThis is the control; participants only partake in one day's worth of the introduction or foundational mindfulness activities on the HMI app. |
| Purpose Only | Experimental | Behavioral: Purpose OnlyParticipants partake in the introduction or foundational mindfulness for one day and then perform purpose-based mindfulness techniques for 5 days on the HMI app. |
| Connection Only | Experimental | Behavioral: Connection OnlyParticipants partake in the introduction or foundational mindfulness for one day and then perform connection-based mindfulness techniques for 5 days on the HMI app. |
| Connection and Purpose | Experimental | Behavioral: Connection and PurposeParticipants partake in the introduction or foundational mindfulness for one day and then perform connection and purpose-based mindfulness techniques for 5 days on the HMI app. |
| Awareness Only | Experimental | Behavioral: Awareness OnlyParticipants partake in the introduction or foundational mindfulness for one day and then perform awareness-based mindfulness techniques for 5 days on the HMI app. |
| Awareness and Purpose | Experimental | Behavioral: Awareness and PurposeParticipants partake in the introduction or foundational mindfulness for one day and then perform awareness and connection-based mindfulness techniques for 5 days on the HMI app. |
| Awareness, Purpose, and Connection | Experimental | Behavioral: Awareness, Purpose, and ConnectionParticipants partake in the introduction or foundational mindfulness for one day and then perform connection, awareness, and purpose-based mindfulness techniques for 5 days on the HMI app. |
| Awareness and Connection | Experimental | Behavioral: Awareness and ConnectionParticipants partake in the introduction or foundational mindfulness for one day and then perform awareness and connection-based mindfulness techniques for 5 days on the HMI app. |
Who may qualify
- Ages
- 18 to 29 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Between 18-29 years
- Must identify as a sexual minority (e.g. gay, bisexual, sexually fluid, etc.)
- Must identify as an underrepresented racial/ethnic minority
- Have an active cell phone service and be able to access the cell phone 7 days a week between 6 p.m. and 6 a.m. the next morning
- Be willing and able to receive up to 6 text messages per day
Key exclusion criteria (8 listed)
- Not between 18-29 years
- Does not identify as a sexual minority (e.g. gay, bisexual, sexually fluid, etc.)
- Does not identify as an underrepresented racial/ethnic minority
- Does not have an active cell phone service and or ability to access the cell phone 7 days a week between 6 p.m. and 6 a.m. the next morning
- Not willing and able to receive up to 6 text messages per day
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 |
|---|---|---|
| Introduction OnlyThis is the placebo condition in which participants engage in one day of introductory mindfulness activities. | Behavioural | Introduction Only |
| Purpose OnlyParticipants engage in one day of introductory mindfulness activities followed up by 5 days of purpose-based mindfulness techniques. | Behavioural | Purpose Only |
| Connection OnlyParticipants engage in one day of introductory mindfulness activities followed up by 5 days of connection-based mindfulness techniques. | Behavioural | Connection Only |
| Connection and PurposeParticipants engage in one day of introductory mindfulness activities followed up by 5 days of connection and purpose-based mindfulness techniques. | Behavioural | Connection and Purpose |
| Awareness OnlyParticipants engage in one day of introductory mindfulness activities followed up by 5 days of awareness-based mindfulness techniques. | Behavioural | Awareness Only |
| Awareness and PurposeParticipants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and purpose-based mindfulness techniques. | Behavioural | Awareness and Purpose |
| Awareness, Purpose, and ConnectionParticipants engage in one day of introductory mindfulness activities followed up by 5 days of awareness, connection, and purpose-based mindfulness techniques | Behavioural | Awareness, Purpose, and Connection |
| Awareness and ConnectionParticipants engage in one day of introductory mindfulness activities followed up by 5 days of awareness and connection-based mindfulness techniques. | Behavioural | Awareness and Connection |
Primary outcome
Change from Baseline in Perceived Stress on the Perceived Stress Scale at Day 5
Time frame: Baseline through study completion, up to one year
The primary outcome for this study is change in perceived stress as measured by the Perceived Stress Scale from baseline to Day 5 among all study participants.
Change from Baseline in Satisfaction with Life on the Satisfaction with Life Scale at Day 5
Time frame: Baseline through study completion, up to one year
The primary outcome for this study is change in perceived satisfaction with life as measured by the Satisfaction with Life Scale from baseline to Day 5 among all study participants.
1 secondary outcome
Optimized Intervention Package
Time frame: Through study completion, an average of 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Derived from this study: PubMed 42524134Cook SH, Wood EP, Rodrigues M, Delorme M, Tatar R, Goldberg SB, Javdani S, Godfrey E. A Daily Digital Mindfulness Meditation to Reduce Stress from Discrimination Among Racially Diverse Sexual and Gender Minorities: Preparation Phase of the Multi-Phase Optimization Strategy (MOST). Mindfulness (N Y). 2026 May 21:10.1007/s12671-026-02874-y. doi: 10.1007/s12671-026-02874-y. Online ahead of print.
- Derived from this study: PubMed 34928237Cook SH, Wood EP, Mirin N, Bandel M, Delorme M, Gad L, Jayakar O, Mustafa Z, Tatar R, Javdani S, Godfrey E. A Mindfulness-Based Intervention to Alleviate Stress From Discrimination Among Young Sexual and Gender Minorities of Color: Protocol for a Pilot Optimization Trial. JMIR Res Protoc. 2022 Jan 14;11(1):e35593. doi: 10.2196/35593.
- Individual participant dataSharing planned: No. N/A (not to be shared with other researchers)
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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.
Stephanie H Cook, DrPH principal investigator
New York University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Introduction Only, Purpose Only and Connection Only in people with Social Discrimination and Sexual and Gender Minorities, run by New York 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 8 inclusion and 8 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 23 Nov 2021. 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. Some participants in this study may receive a placebo. 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?
Contact Stephanie H Cook, DrPH (212-992-5635, sc5810@nyu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Perceived Stress on the Perceived Stress Scale at Day 5 (time frame: Baseline through study completion, up to one year). The study lists 2 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 NCT05131360, which also lists 2 linked publications.
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 Nov 2021.