AnxietyCAHMP-EDNCT04426318
COVID-19 and the Healthy Minds Program for Educators
A study testing Healthy Minds Program Foundations Training in people with Anxiety and Depression, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Anxiety, Depression, Psychological Stress
- What is being tested?
- Healthy Minds Program Foundations Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 698 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jun 2020to 12 Jan 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Ages 18 years old and up
- Employees of a K-12 school district in Wisconsin
- Smartphone or device that can download apps from Google Play or the iTunes app store
Who cannot join
- Individuals under 18 years old
- Significant meditation experience:
- Meditation retreat experience (meditation retreat or yoga/body practice retreat with significant meditation component),
- Regular meditation practice weekly for over 1 year OR daily practice within the previous 6 months; or
- Previous use of the HMP app.
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression score > 70
Trial locations and contacts
1 site in 1 country.
About this study
This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.
Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.
The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.
- Conditions
- Anxiety, Depression, Psychological Stress, Psychological Distress, Well-being
- Being tested
- Healthy Minds Program Foundations Training
- Medical subject headings
- Anxiety Disorders, Depression, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Minds Program Foundations TrainingBehavioural
Also called meditation, mindfulness
The HMP is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. The program is unique in several ways. First, all program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). Second, in addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Minds Program Foundations Training | Experimental | Healthy Minds Program (HMP) Description:
The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. Receives: Behavioral: Healthy Minds Program Foundations Training |
| Wait-list control | No intervention | Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.
Measured: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Secondary outcomes (13)
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
A measure of acting with mindful awareness. The total possible range in scores is 8-40, with higher scores indicating greater levels of this facet of mindfulness.
Measured: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Drexel Defusion Scale (DDS)
Psychological distancing (i.e., defusion) will be assessed with the 10-item Drexel Defusion Scale (DDS). The total possible range in scores is 0-50, with higher scores indicating greater levels of psychological distancing.
Measured: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Meaning in Life Questionnaire
The Meaning in Life Questionnaire Presence subscale will be used to measure perceptions of meaning and purpose in life. The total possible range in scores is 5 - 35 with higher scores indicating greater levels of meaning.
Measured: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the NIH Toolbox Loneliness Scale
A measure of loneliness (i.e, lack of social connectedness). The total possible range in scores is 1-5, representing the average across all items; higher scores indicate greater levels of loneliness.
Measured: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Conway COVID Questionnaire Subscale Scores
The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.
Measured: baseline
Conway COVID Questionnaire Subscale Scores
The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.
Measured: 4 weeks (post intervention)
Conway COVID Questionnaire Subscale Scores
The Conway COVID Questionnaire is a new, 16-tem measure of coronavirus related distress and related experiences. Subscales include: perceived threat, financial scale, resource scale, psychological scale, symptoms scale, proximity to others scale, and news scale. Ratings from 1 to 7 with 1 = "not true of me at all" and 7 = "very true of me" with higher scores representing greater perceived threat. Mean for each subscale reported.
Measured: 16 weeks (3 months post-intervention)
Self-Compassion Scale Short Form Score
The Self-Compassion Scale Short Form will be used to measure self-compassion. The total possible range in scores is 12-60, with higher scores indicating greater levels of self-compassion.
Measured: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Perseverative Thought Questionnaire
Negative ruminative thinking will be measured with the Perseverative Thought Questionnaire. The total possible range in scores is 0-60, with higher scores indicating greater levels negative ruminative thinking.
Measured: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
Well-being will be measured using the WHO-5. The total possible range in scores is 0-25, with higher scores indicating greater levels of well-being.
Measured: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for prosocial construal is from 1 to 7, with higher scores representing greater prosocial construal.
Measured: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Neutral Face Rating Task: Race Bias
The Neutral Face Rating task is a novel measure of prosocial construal (average likability ratings) and race bias (average liking of white faces minus the average liking of black faces). Total score for race bias range from -6 to 6, with higher scores representing greater bias favoring white faces (negative scores on the bias measure indicate bias for liking black faces more than white faces).
Measured: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Growth Mindset Scale for Well-Being
A measure of fixed versus incremental mindset regarding well-being. The average across items for a possible range in scores from 1-6 will be measured, with higher scores indicating greater levels of incremental views on well-being (i.e., it can be learned).
Measured: baseline, 4 weeks (post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2020
- Study start14 Jun 2020
- Primary completion12 Jan 2021
- Study completion12 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (6)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
- Model description
- Random parallel assignment
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 698 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Chan Zuckerberg Initiative, Healthy Minds Innovations, Center for Healthy Minds
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04426318
- Sponsor's protocol ID
- 2020-0533
- Other IDs
- A171600, EDUC/COUNSELING PSYCH, Protocol Approval 10/15/2020
- Acronym
- CAHMP-ED
- Status last verified
- Aug 2024
- First submitted
- 9 Jun 2020
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.
Publications
Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.
PubMed 34000843Hirshberg MJ, Davidson RJ, Goldberg SB. Educators Are Not Alright: Mental Health During COVID-19. Educ Res. 2023 Jan;52(1):48-52. doi: 10.3102/0013189X221142595.
PubMed 37379444Goldberg SB, Jiwani Z, Dahl CJ, Tatar R, Dunne JD, Davidson RJ, Hirshberg MJ. Sitting and Active Meditation Practice: Utilization and Associations with Outcomes in Naturalistic and Clinical Trial Data. Mindfulness (N Y). 2026 Mar 9;17(4):1120-37. doi: 10.1007/s12671-026-02787-w. Online ahead of print.
PubMed 41809576Goldberg SB, Bolt DM, Dahl CJ, Davidson RJ, Hirshberg MJ. Does it matter how meditation feels? An experience sampling study. J Consult Clin Psychol. 2024 Aug;92(8):531-541. doi: 10.1037/ccp0000857.
PubMed 39347788Webb CA, Hirshberg MJ, Gonzalez O, Davidson RJ, Goldberg SB. Revealing subgroup-specific mechanisms of change via moderated mediation: A meditation intervention example. J Consult Clin Psychol. 2024 Jan;92(1):44-53. doi: 10.1037/ccp0000842. Epub 2023 Sep 28.
PubMed 37768631Webb CA, Hirshberg MJ, Davidson RJ, Goldberg SB. Personalized Prediction of Response to Smartphone-Delivered Meditation Training: Randomized Controlled Trial. J Med Internet Res. 2022 Nov 8;24(11):e41566. doi: 10.2196/41566.
PubMed 36346668
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COVID-19 and the Healthy Minds Program for Educators
- ClinicalTrials.gov ID
- NCT04426318
- Acronym / sponsor ID
- CAHMP-ED / 2020-0533
- Conditions
- Anxiety, Depression, Psychological Stress, Psychological Distress, Well-being
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 698 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Chan Zuckerberg Initiative, Healthy Minds Innovations, Center for Healthy Minds
- Study start
- 14 Jun 2020 (actual)
- Primary completion
- 12 Jan 2021 (actual)
- Study completion
- 12 Jan 2021 (actual)
- First posted
- 11 Jun 2020 (actual)
- Results
- Posted 10 Feb 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized controlled trial (RCT) of the four-week Healthy Minds Program (HMP) app Foundations training in employees of a mid-size urban school district in the United States during the summer of 2020, in the midst of the novel coronavirus pandemic. A 3-month follow-up in the fall of 2020 will also be conducted.
Participants will be recruited via email and mailed postcards, and will first complete an online screen. Eligible participants will then enter a waiting zone for between 2-days and 2-weeks before they are sent the online pre-test. Upon completion of the pre-test, participants will be assigned to condition via a simple random number generator. If assigned to the intervention (i.e., the Healthy Minds Program App), participants will receive instructions and support in downloading and activating the app. Every 7-days over the 4-week intervention period participants in both conditions will complete the same set of measures. A full battery of measures will be administered a second time post-test, following the 4-week intervention period. Three-months after post-test, a follow-up assessment will be conducted.
The investigators predict that participants assigned to the intervention will demonstrate significantly reduced psychological distress after the intervention, and these decreases will persist at the 3-month follow-up. Further, it is hypothesized that baseline participant characteristics and early experience of the intervention will predict treatment adherence, study drop-out and outcomes, and that treatment engagement will moderate outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Random parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Healthy Minds Program Foundations Training | Experimental | Behavioral: Healthy Minds Program Foundations TrainingHealthy Minds Program (HMP) Description: The HMP app was developed by Healthy Minds Innovations at the UW Center for Healthy Minds, and is based on the work of Richard Davidson, PhD. HMP is designed to promote and protect psychological well-being through sustainable skills training. The program is grounded in constituents of psychological well-being identified in empirical literature. HMP provides core content, with instruction administered through a curriculum of high-quality guided practices. HMP is based on research on eudaimonic well-being (e.g., environmental mastery, purpose) and brain-based skills that underlie these qualities (e.g., regulation of attention, mental flexibility). HMP has >100 guided audio practices that address 4 constituents of well-being: awareness, connection, insight, and purpose. |
| Wait-list control | No intervention | –Participants assigned to the wait-list control will not receive treatment for the intervention and follow-up period. They will be provided access to the HMP Foundations training after completing follow-up testing. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 18 years old and up
- Employees of a K-12 school district in Wisconsin
- Smartphone or device that can download apps from Google Play or the iTunes app store
Key exclusion criteria (6 listed)
- Individuals under 18 years old
- Significant meditation experience:
- Patient-Reported Outcomes Measurement Information System (PROMIS) depression score > 70
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 |
|---|---|---|
| Healthy Minds Program Foundations TrainingAlso: meditation, mindfulnessThe HMP is a novel, smartphone-based app that provides a series of guided meditation practices on four primary constituents of well-being: Awareness, Connection, Insight, and Purpose. The program is unique in several ways. First, all program elements are introduced with a summary of the scientific evidence supporting its constituent elements (e.g., Awareness and well-being). Second, in addition to standard sitting meditation practices found in many meditation-based behavioral interventions, the HMP offers active practices in which participants can develop the same skills but while embedding practice into activities they already do in their normal daily routine. | Behavioural | Healthy Minds Program Foundations Training |
Primary outcome
Change From Baseline on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Psychological distress will be assessed by aggregating 3 measures: PROMIS anxiety and PROMIS depression, and the NIH Toolbox Perceived Stress Scale. Averages will be z-scored with a mean of 0 and a standard deviation 1. Higher scores indicate increased psychological distress.
13 secondary outcomes
Change From Baseline on the Five Facet Mindfulness Questionnaire Act With Awareness Subscale
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Drexel Defusion Scale (DDS)
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Meaning in Life Questionnaire
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the NIH Toolbox Loneliness Scale
Time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Conway COVID Questionnaire Subscale Scores
Time frame: baseline
Conway COVID Questionnaire Subscale Scores
Time frame: 4 weeks (post intervention)
Conway COVID Questionnaire Subscale Scores
Time frame: 16 weeks (3 months post-intervention)
Self-Compassion Scale Short Form Score
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Perseverative Thought Questionnaire
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the World Health Organization 5-item (WHO-5) Well-being Scale
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Neutral Face Rating Task: Prosocial Construal
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Neutral Face Rating Task: Race Bias
Time frame: baseline, 4 weeks (post intervention), 16 weeks (3 months post-intervention)
Change From Baseline on the Growth Mindset Scale for Well-Being
Time frame: baseline, 4 weeks (post intervention)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 34000843Goldberg SB, Baldwin SA, Riordan KM, Torous J, Dahl CJ, Davidson RJ, Hirshberg MJ. Alliance With an Unguided Smartphone App: Validation of the Digital Working Alliance Inventory. Assessment. 2022 Sep;29(6):1331-1345. doi: 10.1177/10731911211015310. Epub 2021 May 18.
- Results publication: PubMed 37379444Hirshberg MJ, Davidson RJ, Goldberg SB. Educators Are Not Alright: Mental Health During COVID-19. Educ Res. 2023 Jan;52(1):48-52. doi: 10.3102/0013189X221142595.
- Derived from this study: PubMed 41809576Goldberg SB, Jiwani Z, Dahl CJ, Tatar R, Dunne JD, Davidson RJ, Hirshberg MJ. Sitting and Active Meditation Practice: Utilization and Associations with Outcomes in Naturalistic and Clinical Trial Data. Mindfulness (N Y). 2026 Mar 9;17(4):1120-37. doi: 10.1007/s12671-026-02787-w. Online ahead of print.
- Derived from this study: PubMed 39347788Goldberg SB, Bolt DM, Dahl CJ, Davidson RJ, Hirshberg MJ. Does it matter how meditation feels? An experience sampling study. J Consult Clin Psychol. 2024 Aug;92(8):531-541. doi: 10.1037/ccp0000857.
- Derived from this study: PubMed 37768631Webb CA, Hirshberg MJ, Gonzalez O, Davidson RJ, Goldberg SB. Revealing subgroup-specific mechanisms of change via moderated mediation: A meditation intervention example. J Consult Clin Psychol. 2024 Jan;92(1):44-53. doi: 10.1037/ccp0000842. Epub 2023 Sep 28.
- Derived from this study: PubMed 36346668Webb CA, Hirshberg MJ, Davidson RJ, Goldberg SB. Personalized Prediction of Response to Smartphone-Delivered Meditation Training: Randomized Controlled Trial. J Med Internet Res. 2022 Nov 8;24(11):e41566. doi: 10.2196/41566.
- OSF RegistryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Data will be de-identified and listed in public data registries (i.e., osf) based on the publication of preregistered study hypotheses on a manuscript by manuscript basis.
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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 Healthy Minds Program Foundations Training in people with Anxiety and Depression, 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 3 inclusion and 6 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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 10 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 on an Aggregate Measure of Psychological Distress That Averages the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety and Depressive Measures and the NIH Perceived Stress Scale (time frame: baseline, after weeks 1, 2, and 3 of the intervention, 4 weeks (post intervention), 16 weeks (3 months post-intervention)). 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 NCT04426318, which also lists 6 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 19 Sep 2024; AzTrials last refreshed its copy on 27 Oct 2026.