Well-Being, PsychologicalNCT06165497
Short Practices Well-being Study
A study testing Meditation practices and Internet-as-usual in people with Well-Being, Psychological, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The goal of this research study is to better understand the effects of short practices on well-being. Participants will be asked to complete a task that will take 5-10 minutes, followed by a set of surveys. They will also be invited to complete a second set of surveys ~7 days later. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Well-Being, Psychological
- What is being tested?
- Meditation practices and Internet-as-usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,049 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Nov 2023to 15 Dec 2023
- 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
- United States and United Kingdom residents 18 year or older
Who cannot join
- Inability or unwillingness to complete the study
- Fail to pass the attention check embedded in the survey
Trial locations and contacts
1 site in 1 country.
About this study
The goal of this research study is to better understand the effects of short practices on well-being.
Participants will be asked to complete a task that will take 5-10 minutes, followed by a set of surveys. They will also be invited to complete a second set of surveys ~7 days later.
Read the detailed description
The aim of this study is to better understand the effects of short practices on well-being. In the initial part of the study, participants will be required to complete a set of surveys assessing their health along with demographic measures. Participants will also be asked to complete a brief task. They will be asked sensitive questions (e.g., about your psychological state, mental health). To have their submission accepted, participants must correctly answer questions designed to check if they are paying attention. This part of the study will take approximately 24 minutes to complete. Anonymized data may be made available to other researchers. One week after completing this study, participants will be invited to complete a second set of surveys.
- Conditions
- Well-Being, Psychological
- Being tested
- Meditation practices, Internet-as-usual
- Keywords
- meditation, mobile health, mindfulness, self-compassion, gratitude
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meditation practicesBehavioural
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
Internet-as-usualOther
Participants will be instructed to use the internet as they typically do.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness, 5 minutes, male voice | Experimental | Mindfulness meditation, 5 minutes duration, with a male speaker. Receives: Behavioral: Meditation practices |
| Mindfulness, 10 minutes, male voice | Experimental | Mindfulness meditation, 10 minutes duration, with a male speaker. Receives: Behavioral: Meditation practices |
| Mindfulness, 5 minutes, female voice | Experimental | Mindfulness meditation, 5 minutes duration, with a female speaker. Receives: Behavioral: Meditation practices |
| Mindfulness, 10 minutes, female voice | Experimental | Mindfulness meditation, 10 minutes duration, with a female speaker. Receives: Behavioral: Meditation practices |
| Self-compassion, 5 minutes, male voice | Experimental | Self-compassion meditation, 5 minutes duration, with a male speaker. Receives: Behavioral: Meditation practices |
| Self-compassion, 10 minutes, male voice | Experimental | Self-compassion meditation, 10 minutes duration, with a male speaker. Receives: Behavioral: Meditation practices |
| Self-compassion, 5 minutes, female voice | Experimental | Self-compassion meditation, 5 minutes duration, with a female speaker. Receives: Behavioral: Meditation practices |
| Self-compassion, 10 minutes, female voice | Experimental | Self-compassion meditation, 10 minutes duration, with a female speaker. Receives: Behavioral: Meditation practices |
| Gratitude, 5 minutes, male voice | Experimental | Gratitude meditation, 5 minutes duration, with a male speaker. Receives: Behavioral: Meditation practices |
| Gratitude, 10 minutes, male voice | Experimental | Gratitude meditation, 10 minutes duration, with a male speaker. Receives: Behavioral: Meditation practices |
| Gratitude, 5 minutes, female voice | Experimental | Gratitude meditation, 5 minutes duration, with a female speaker. Receives: Behavioral: Meditation practices |
| Gratitude, 10 minutes, female voice | Experimental | Gratitude meditation, 10 minutes duration, with a female speaker. Receives: Behavioral: Meditation practices |
| Internet-as-usual, 5 minutes | Other | Participants will be instructed to use the internet as they typical do for 5 minutes. Receives: Other: Internet-as-usual |
| Internet-as-usual, 10 minutes | Other | Participants will be instructed to use the internet as they typical do for 10 minutes. Receives: Other: Internet-as-usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Positive and Negative Affect Schedule Positive Affect
Participants respond to a 10-item survey indicating their current mood. Response options range from 1 (very slightly or not at all) to 5 (extremely). Five items reflect positive affect. Higher scores indicate higher positive affect.
Measured: Current positive affect pre- and post- short tasks (up to 10 minutes).
Positive and Negative Affect Schedule Negative Affect
Participants respond to a 10-item survey indicating their current mood. Response options range from 1 (very slightly or not at all) to 5 (extremely). Five items reflect negative affect. Higher scores indicate higher negative affect.
Measured: Current negative affect pre- and post- short tasks (up to 10 minutes).
Secondary outcomes (16)
State Mindfulness Scale
Participants respond to a 21-item survey indicating their state mindfulness. Response options range from 1 (not at all) to 5 (very well). Higher scores indicate higher state mindfulness.
Measured: Up to 10 minutes
State Self-Compassion Scale Short Form
Participants respond to a 6-item survey indicating their state self-compassion. Response options range from 1 (not at all true for me) to 5 (very true for me). Higher scores indicate higher state self-compassion.
Measured: Up to 10 minutes
Gratitude Adjective Checklist - 3
Participants respond to a 3-item survey indicating their state gratitude. Response options range from 1 (not at all) to 5 (extremely). Higher scores indicate higher state gratitude.
Measured: Up to 10 minutes
Adverse reaction to short tasks
Participants will indicate whether they had a "distressing experience" (yes/no) during the task they completed.
Measured: Up to 10 minutes
Meditation practice using the short task practice type.
Participants will be asked how many days they practiced the three meditation practice types during the past week.
Measured: 7-day follow-up
Healthy Minds Program download
Participants will be asked whether they downloaded the Healthy Minds Program and how many days they used the app if they downloaded it.
Measured: 7-day follow-up
Ruminative Response Style
Participants respond to an 8-item survey indicating their level of rumination. Response options range from 1 (almost never) to 4 (almost always). Higher scores indicate higher rumination.
Measured: Pre- short tasks and 7-day follow-up
NIH Toolbox Loneliness
Participants respond to a 5-item survey indicating their level of loneliness. Response options range from 1 (never) to 5 (always). Higher scores indicate higher loneliness.
Measured: Pre- short tasks and 7-day follow-up
Perceived Stress Scale
Participants respond to a 4-item survey indicating their level of perceived stress. Response options range from 1 (never) to 5 (very often). Higher scores indicate higher perceived stress.
Measured: Pre- short tasks and 7-day follow-up
PROMIS Anxiety
Participants respond to a 4-item survey indicating their level of anxiety. Response options range from 1 (never) to 5 (always). Higher scores indicate higher anxiety.
Measured: Pre- short tasks and 7-day follow-up
PROMIS Depression
Participants respond to a 4-item survey indicating their level of depression. Response options range from 1 (never) to 5 (always). Higher scores indicate higher depression.
Measured: Pre- short tasks and 7-day follow-up
Self-Compassion Scale Short Form
Participants respond to a 12-item survey indicating their level of trait self-compassion. Response options range from 1 (almost never) to 5 (almost always). Higher scores indicate higher trait self-compassion.
Measured: Pre- short tasks and 7-day follow-up
Five Facet Mindfulness Questionnaire Short Form
Participants respond to a 15-item survey indicating their level of trait mindfulness. Response options range from 1 (never or very rarely true) to 5 (very often or always true). Higher scores indicate higher trait mindfulness.
Measured: Pre- short tasks and 7-day follow-up
Gratitude Questionnaire
Participants respond to a 6-item survey indicating their level of trait gratitude. Response options range from 1 (strongly disagree) to 7 (strongly agree). Higher scores indicate higher trait gratitude.
Measured: Pre- short tasks and 7-day follow-up
Positive and Negative Affect Schedule Positive Affect
Participants respond to a 10-item survey indicating their current mood. Response options range from 1 (very slightly or not at all) to 5 (extremely). Five items reflect positive affect. Higher scores indicate higher positive affect.
Measured: 7-day follow-up
Positive and Negative Affect Schedule Negative Affect
Participants respond to a 10-item survey indicating their current mood. Response options range from 1 (very slightly or not at all) to 5 (extremely). Five items reflect negative affect. Higher scores indicate higher negative affect.
Measured: 7-day follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start30 Nov 2023
- Primary completion15 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5,049 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Goldberg, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165497
- Sponsor's protocol ID
- 2023-1324
- Other IDs
- Protocol Version 11/20/2023, A171600, EDUC/COUNSELING PSYCH
- Status last verified
- Dec 2023
- First submitted
- 28 Nov 2023
- Last updated
- 3 Jan 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Practices Well-being Study
- ClinicalTrials.gov ID
- NCT06165497
- Acronym / sponsor ID
- 2023-1324
- Conditions
- Well-Being, Psychological
- Keywords
- meditation, mobile health, mindfulness, self-compassion, gratitude
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,049 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 15 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 11 Dec 2023 (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 goal of this research study is to better understand the effects of short practices on well-being.
Participants will be asked to complete a task that will take 5-10 minutes, followed by a set of surveys. They will also be invited to complete a second set of surveys ~7 days later.
Detailed description
The aim of this study is to better understand the effects of short practices on well-being. In the initial part of the study, participants will be required to complete a set of surveys assessing their health along with demographic measures. Participants will also be asked to complete a brief task. They will be asked sensitive questions (e.g., about your psychological state, mental health). To have their submission accepted, participants must correctly answer questions designed to check if they are paying attention. This part of the study will take approximately 24 minutes to complete. Anonymized data may be made available to other researchers. One week after completing this study, participants will be invited to complete a second set of surveys.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 14
| Arm | Type | Receives |
|---|---|---|
| Mindfulness, 5 minutes, male voice | Experimental | Behavioral: Meditation practicesMindfulness meditation, 5 minutes duration, with a male speaker. |
| Mindfulness, 10 minutes, male voice | Experimental | Behavioral: Meditation practicesMindfulness meditation, 10 minutes duration, with a male speaker. |
| Mindfulness, 5 minutes, female voice | Experimental | Behavioral: Meditation practicesMindfulness meditation, 5 minutes duration, with a female speaker. |
| Mindfulness, 10 minutes, female voice | Experimental | Behavioral: Meditation practicesMindfulness meditation, 10 minutes duration, with a female speaker. |
| Self-compassion, 5 minutes, male voice | Experimental | Behavioral: Meditation practicesSelf-compassion meditation, 5 minutes duration, with a male speaker. |
| Self-compassion, 10 minutes, male voice | Experimental | Behavioral: Meditation practicesSelf-compassion meditation, 10 minutes duration, with a male speaker. |
| Self-compassion, 5 minutes, female voice | Experimental | Behavioral: Meditation practicesSelf-compassion meditation, 5 minutes duration, with a female speaker. |
| Self-compassion, 10 minutes, female voice | Experimental | Behavioral: Meditation practicesSelf-compassion meditation, 10 minutes duration, with a female speaker. |
| Gratitude, 5 minutes, male voice | Experimental | Behavioral: Meditation practicesGratitude meditation, 5 minutes duration, with a male speaker. |
| Gratitude, 10 minutes, male voice | Experimental | Behavioral: Meditation practicesGratitude meditation, 10 minutes duration, with a male speaker. |
| Gratitude, 5 minutes, female voice | Experimental | Behavioral: Meditation practicesGratitude meditation, 5 minutes duration, with a female speaker. |
| Gratitude, 10 minutes, female voice | Experimental | Behavioral: Meditation practicesGratitude meditation, 10 minutes duration, with a female speaker. |
| Internet-as-usual, 5 minutes | Other | Other: Internet-as-usualParticipants will be instructed to use the internet as they typical do for 5 minutes. |
| Internet-as-usual, 10 minutes | Other | Other: Internet-as-usualParticipants will be instructed to use the internet as they typical do for 10 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- United States and United Kingdom residents 18 year or older
Key exclusion criteria (2 listed)
- Inability or unwillingness to complete the study
- Fail to pass the attention check embedded in the survey
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 |
|---|---|---|
| Meditation practicesParticipants will listen to recordings of short meditation practices drawn from the Healthy Minds Program. | Behavioural | Gratitude, 10 minutes, female voice, Gratitude, 10 minutes, male voice, Gratitude, 5 minutes, female voice, Gratitude, 5 minutes, male voice, Mindfulness, 10 minutes, female voice, Mindfulness, 10 minutes, male voice, Mindfulness, 5 minutes, female voice, Mindfulness, 5 minutes, male voice, Self-compassion, 10 minutes, female voice, Self-compassion, 10 minutes, male voice, Self-compassion, 5 minutes, female voice, Self-compassion, 5 minutes, male voice |
| Internet-as-usualParticipants will be instructed to use the internet as they typically do. | Other | Internet-as-usual, 10 minutes, Internet-as-usual, 5 minutes |
Primary outcome
Positive and Negative Affect Schedule Positive Affect
Time frame: Current positive affect pre- and post- short tasks (up to 10 minutes).
Participants respond to a 10-item survey indicating their current mood. Response options range from 1 (very slightly or not at all) to 5 (extremely). Five items reflect positive affect. Higher scores indicate higher positive affect.
Positive and Negative Affect Schedule Negative Affect
Time frame: Current negative affect pre- and post- short tasks (up to 10 minutes).
Participants respond to a 10-item survey indicating their current mood. Response options range from 1 (very slightly or not at all) to 5 (extremely). Five items reflect negative affect. Higher scores indicate higher negative affect.
16 secondary outcomes
State Mindfulness Scale
Time frame: Up to 10 minutes
State Self-Compassion Scale Short Form
Time frame: Up to 10 minutes
Gratitude Adjective Checklist - 3
Time frame: Up to 10 minutes
Adverse reaction to short tasks
Time frame: Up to 10 minutes
Meditation practice using the short task practice type.
Time frame: 7-day follow-up
Healthy Minds Program download
Time frame: 7-day follow-up
Ruminative Response Style
Time frame: Pre- short tasks and 7-day follow-up
NIH Toolbox Loneliness
Time frame: Pre- short tasks and 7-day follow-up
Perceived Stress Scale
Time frame: Pre- short tasks and 7-day follow-up
PROMIS Anxiety
Time frame: Pre- short tasks and 7-day follow-up
PROMIS Depression
Time frame: Pre- short tasks and 7-day follow-up
Self-Compassion Scale Short Form
Time frame: Pre- short tasks and 7-day follow-up
Five Facet Mindfulness Questionnaire Short Form
Time frame: Pre- short tasks and 7-day follow-up
Gratitude Questionnaire
Time frame: Pre- short tasks and 7-day follow-up
Positive and Negative Affect Schedule Positive Affect
Time frame: 7-day follow-up
Positive and Negative Affect Schedule Negative Affect
Time frame: 7-day follow-up
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 3 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Simon Goldberg, PhD 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 Meditation practices and Internet-as-usual in people with Well-Being, Psychological, 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 2 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 3 Jan 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?
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?
Positive and Negative Affect Schedule Positive Affect (time frame: Current positive affect pre- and post- short tasks (up to 10 minutes).). 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?
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 3 Jan 2024.