- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06165497
Short Practices Well-being Study
December 29, 2023 updated by: University of Wisconsin, Madison
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
5049
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Wisconsin
-
Madison, Wisconsin, United States, 53705
- University of Wisconsin
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- United States and United Kingdom residents 18 year or older
Exclusion Criteria:
- Inability or unwillingness to complete the study
- Fail to pass the attention check embedded in the survey
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mindfulness, 5 minutes, male voice
Mindfulness meditation, 5 minutes duration, with a male speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Mindfulness, 10 minutes, male voice
Mindfulness meditation, 10 minutes duration, with a male speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Mindfulness, 5 minutes, female voice
Mindfulness meditation, 5 minutes duration, with a female speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Mindfulness, 10 minutes, female voice
Mindfulness meditation, 10 minutes duration, with a female speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Self-compassion, 5 minutes, male voice
Self-compassion meditation, 5 minutes duration, with a male speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Self-compassion, 10 minutes, male voice
Self-compassion meditation, 10 minutes duration, with a male speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Self-compassion, 5 minutes, female voice
Self-compassion meditation, 5 minutes duration, with a female speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Self-compassion, 10 minutes, female voice
Self-compassion meditation, 10 minutes duration, with a female speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Gratitude, 5 minutes, male voice
Gratitude meditation, 5 minutes duration, with a male speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Gratitude, 10 minutes, male voice
Gratitude meditation, 10 minutes duration, with a male speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Gratitude, 5 minutes, female voice
Gratitude meditation, 5 minutes duration, with a female speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Experimental: Gratitude, 10 minutes, female voice
Gratitude meditation, 10 minutes duration, with a female speaker.
|
Participants will listen to recordings of short meditation practices drawn from the Healthy Minds Program.
|
|
Other: Internet-as-usual, 5 minutes
Participants will be instructed to use the internet as they typical do for 5 minutes.
|
Participants will be instructed to use the internet as they typically do.
|
|
Other: Internet-as-usual, 10 minutes
Participants will be instructed to use the internet as they typical do for 10 minutes.
|
Participants will be instructed to use the internet as they typically do.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Current positive affect pre- and post- short tasks (up to 10 minutes).
|
|
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.
|
Current negative affect pre- and post- short tasks (up to 10 minutes).
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
State Mindfulness Scale
Time Frame: Up to 10 minutes
|
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.
|
Up to 10 minutes
|
|
State Self-Compassion Scale Short Form
Time Frame: Up to 10 minutes
|
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.
|
Up to 10 minutes
|
|
Gratitude Adjective Checklist - 3
Time Frame: Up to 10 minutes
|
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.
|
Up to 10 minutes
|
|
Adverse reaction to short tasks
Time Frame: Up to 10 minutes
|
Participants will indicate whether they had a "distressing experience" (yes/no) during the task they completed.
|
Up to 10 minutes
|
|
Meditation practice using the short task practice type.
Time Frame: 7-day follow-up
|
Participants will be asked how many days they practiced the three meditation practice types during the past week.
|
7-day follow-up
|
|
Healthy Minds Program download
Time Frame: 7-day follow-up
|
Participants will be asked whether they downloaded the Healthy Minds Program and how many days they used the app if they downloaded it.
|
7-day follow-up
|
|
Ruminative Response Style
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
NIH Toolbox Loneliness
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
Perceived Stress Scale
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
PROMIS Anxiety
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
PROMIS Depression
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
Self-Compassion Scale Short Form
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
Five Facet Mindfulness Questionnaire Short Form
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
Gratitude Questionnaire
Time Frame: Pre- short tasks and 7-day follow-up
|
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.
|
Pre- short tasks and 7-day follow-up
|
|
Positive and Negative Affect Schedule Positive Affect
Time Frame: 7-day follow-up
|
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.
|
7-day follow-up
|
|
Positive and Negative Affect Schedule Negative Affect
Time Frame: 7-day follow-up
|
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.
|
7-day follow-up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Simon Goldberg, PhD, University of Wisconsin, Madison
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 30, 2023
Primary Completion (Actual)
December 15, 2023
Study Completion (Actual)
December 15, 2023
Study Registration Dates
First Submitted
November 28, 2023
First Submitted That Met QC Criteria
December 7, 2023
First Posted (Actual)
December 11, 2023
Study Record Updates
Last Update Posted (Estimated)
January 3, 2024
Last Update Submitted That Met QC Criteria
December 29, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 2023-1324
- A171600 (Other Identifier: UW Madison)
- EDUC/COUNSELING PSYCH (Other Identifier: UW Madison)
- Protocol Version 11/20/2023 (Other Identifier: UW Madison)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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