- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05542498
Promoting Stress Management and Engagement in Introductory Physics Courses With Mindfulness and Relaxation
May 5, 2024 updated by: Brian Galla, University of Pittsburgh
Mobile Mindfulness Training and Physics Learning
This study tests the impact of mindfulness vs. relaxation training on psychological threat and challenge, emotions/emotion regulation, motivation/engagement, and performance among undergraduates enrolled in introductory physics courses.
Data used to compare groups will be collected from a variety of sources, including self-report surveys, experience sampling and daily diary assessments, physics learning activities, and academic records.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
303
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
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15260
- University of Pittsburgh
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-
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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- at least 18 years of age
- current University of Pittsburgh undergraduate
- enrolled in introductory physics
- self-reports psychological threat in physics
Exclusion Criteria:
- under 18 years of age
- not a current University of Pittsburgh undergraduate
- not enrolled in introductory physics
- does not self-report psychological threat in physics
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: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mindfulness Training
5-lesson audio-guided mindfulness training program delivered over 5 consecutive days, with two additional writing activities on day 1 and day 5
|
Training is focused on learning and applying the principles of R.A.I.N. (Recognize, Allow, Investigate, Non-identify) in the context of physics learning.
|
Active Comparator: Relaxation Training
5-lesson audio-guided relaxation training program delivered over 5 consecutive days, with two additional writing activities on day 1 and day 5
|
Training is focused on learning and applying relaxation practices (e.g., progressive muscle relaxation, guided imagery) in the context of physics learning.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Daily Physics Emotions from baseline up to 1 week post-intervention assessed via Daily Diary Self-Report
Time Frame: From enrollment up to 1 week post-intervention
|
Daily Physics Emotions measured using 12 self-report items with Likert scale from 0 (not at all) to 4 (an extreme amount).
Daily Physics Emotions are calculated by averaging daily emotion items, with scores closer to 4 indicating experiencing more extreme emotions in physics.
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From enrollment up to 1 week post-intervention
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Mean Change in Daily Responses to Physics Emotions from baseline up to 1 week post-intervention assessed via Daily Diary Self-Report
Time Frame: From enrollment up to 1 week post-intervention
|
Daily reappraisal, perspective shifting, and relaxation measured using 6 self-report items with Likert scale from 0 (not at all true) to 4 (completely true).
Composite scores for reappraisal, perspective shifting, and relaxation are calculated as an average of all items for each subscale, respectively.
Daily responses to emotions ranges from 0 to 4, with higher scores indicating greater use of reappraisal, perspective shifting, or relaxation.
|
From enrollment up to 1 week post-intervention
|
Mean Change in Daily Threat vs. Challenge Appraisals from baseline up to 1 week post-intervention assessed via Daily Diary Self-Report
Time Frame: From enrollment up to 1 week post-intervention
|
Daily Threat vs. Challenge Appraisals measured using 3 self-report items about threat, challenge, and confidence with regarding to unpleasant physics emotions with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
|
From enrollment up to 1 week post-intervention
|
Mean Change in Daily Physics Engagement from baseline up to 1 week post-intervention assessed via Daily Diary Self-Report
Time Frame: From enrollment up to 1 week post-intervention
|
Degree to which students felt engaged in and motivated to learn physics on a daily basis.
Measured using 2 self-report items measured with Likert scale from 1 (not at all motivated/engaged) to 6 (extremely motivated/engaged).
Daily engagement is calculated by averaging both items, with scores closer to 6 indicating more greater physics engagement.
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From enrollment up to 1 week post-intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
State Presence assessed via Ecological Momentary Assessment
Time Frame: during intervention, five days
|
Experiences of decentering and curiosity, measured using 6 self-report items with Likert scale from 0 (not at all) to 4 (very much).
State presence is calculated by averaging decentering and curiosity items, with scores closer to 4 indicating greater state presence.
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during intervention, five days
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State Relaxation assessed via Ecological Momentary Assessment
Time Frame: during intervention, five days
|
Experiences of relaxation, measured using 3 self-report items with Likert scale from 0 (not at all) to 4 (very much).
State relaxation is calculated by averaging relaxation items, with scores closer to 4 indicating greater state relaxation.
|
during intervention, five days
|
State Physics Anxiety assessed via Ecological Momentary Assessment
Time Frame: during intervention, five days
|
Current level of anxiety about physics measured using 1 self-report item with Likert scale from 0 (not at all) to 4 (very much), with scores closer to 4 indicating higher anxiety about physics.
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during intervention, five days
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Mean Change in Physics Anxiety from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Anxiety evaluation or learning while doing physics work, measured using 8 self-report items with Likert scale from 1 (low anxiety) to 5 (high anxiety).
Physics anxiety is calculated as an average of all of the items for each subscale, respectively.
Physics anxiety ranges from 1 to 5, with higher scores indicating greater physics anxiety.
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From enrollment, up to 3 months post-intervention
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Mean Change in Psychological Threat vs. Challenge from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Psychological Threat vs. Challenge, measured using 11 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Psychological threat is calculated by subtracting average of physics demands from average of physics resources.
Difference score ranges from -5 to 5, with scores above zero indicating psychological threat and scores of 0 or lower indicating psychological challenge.
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From enrollment, up to 3 months post-intervention
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Mean Change in Unpleasant Emotions-Can-Be-Enhancing Mindset from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Belief that unpleasant emotions are a signal that learning and growth are possible, measured using 3 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Unpleasant Emotions-Can-Be-Enhancing mindset is calculated as an average of all items ranging from 1 to 6, with higher scores indicating greater endorsement of this mindset.
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From enrollment, up to 3 months post-intervention
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Mean Change in Physics Self-Efficacy from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Belief of efficacy with respect to physics skills and abilities, measured using 5 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Physics Self-Efficacy is calculated as an average of all items from 1 to 6, with higher scores indicating greater self-efficacy in physics.
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From enrollment, up to 3 months post-intervention
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Mean Change in Physics Belonging from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Student's sense of belonging in their physics course, measured using 5 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Physics Belonging is calculated as an average of all items from 1 to 6, with higher scores indicating greater sense of belonging in physics.
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From enrollment, up to 3 months post-intervention
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Mean Change in Metacognitive strategies from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Metacognitive strategies, measured using 7 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Metacognitive strategies are calculated as an average of all items, ranging from 1 to 6, with higher scores indicating greater use of metacognitive strategies.
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From enrollment, up to 3 months post-intervention
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Mean Change in Physics Intelligence Mindset from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Belief that intelligence and abilities for physics can be developed through dedication and hard work, measured using 3 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Growth mindset is calculated as an average of all items ranging from 1 to 6, with higher scores indicating greater growth mindset and lower scores indicating greater fixed mindset.
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From enrollment, up to 3 months post-intervention
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Mean Change in Cognitive Effort from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Cognitive effort, measured using 4 self-report items with Likert scale from (strongly disagree) to 6 (strongly agree).
Cognitive effort is calculated as an average of all items, ranging from 1 to 6, with higher scores indicating greater cognitive effort.
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From enrollment, up to 3 months post-intervention
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Mean Change in Physics Identity from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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The degree by which students associate their self-concept with physics, measured using 4 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Physics Identity is calculated as an average of all items from 1 to 6, with higher scores indicating greater identification with physics.
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From enrollment, up to 3 months post-intervention
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Mean Change in Proactive Mindset from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Proactive mindset, measured using 6 self-report items with Likert scale from 1 (not at all) to 5 (very much).
Proactive mindset is calculated as an average of all items, with higher scores indicating greater proactive mindset.
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From enrollment, up to 3 months post-intervention
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Mean Change in Cognitive Problem-Solving Strategies from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Use of explanation and analogy as problem solving strategies when working on physics, measured using 6 self-report items with Likert scale from (strongly disagree) to 6 (strongly agree).
Each subscale is calculated as an average of all of the items for each subscale, respectively.
Cognitive problem-solving strategies range from 1 to 6, with higher scores indicating greater use of explanation or analogy problem solving strategies.
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From enrollment, up to 3 months post-intervention
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Mean Change in Physics Value from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Perceived interest in and utility value of learning physics, measured using 2 self-report items with Likert scale from 1 to 6. Physics Value is calculated as an average of both items from 1 to 6, with higher scores indicating greater perceived value of learning physics.
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From enrollment, up to 3 months post-intervention
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Performance on Physics problem solving Tasks
Time Frame: 3 days post-intervention
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Physics problem solving tasks that range in difficulty covering content from introductory physics.
Each item is scored for accuracy and solution time.
Multiple choice items are scored as correct or incorrect.
Accuracy scores are averaged across the items with higher scores indicating better physics performance.
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3 days post-intervention
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Performance on the Preparation for Future Learning Task
Time Frame: 3 days post-intervention
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Physics problem solving tasks that include new learning resources (e.g., a worked example) and a transfer task.
Each item is scored for accuracy and latency.
Explanation items are scored on a rubric.
Accuracy scores are summed across items with higher scores indicating better physics learning.
Latencies will be examined for how much time was spent with the learning resource and time spent solving the problems.
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3 days post-intervention
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Judgments of confidence, difficulty, and self-efficacy during the physics problem solving and Preparation for Future Learning tasks assessed via Self-Report
Time Frame: 3 days post-intervention
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Judgments of confidence, difficulty, and self-efficacy during physics problem solving, with each subscale measured using self-report items with Likert scale from 1 to 6.
Each subscale is calculated as an average of all of the items, with higher scores indicating greater confidence, difficulty, and self-efficacy respectively.
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3 days post-intervention
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Problem selection on a Make-a-Physics task
Time Frame: 3 days post-intervention
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Physics problem solving tasks that range in difficulty from more to less challenging.
Participants select problems to be included on a work sheet.
Scores are calculated by summing the number of problems selected for each problem type.
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3 days post-intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Performance in Physics Class
Time Frame: End of semester following intervention, approximately 12 weeks
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End-of-course grades measured via school records.
Higher grades indicate higher classroom performance.
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End of semester following intervention, approximately 12 weeks
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Retention in Physics Classes
Time Frame: End of semester following intervention, approximately 7 months
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Enrollment in second semester of introductory physics course sequence measured via official school records.
Scored dichotomously, 1 for enrolling second semester physics and 0 for not.
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End of semester following intervention, approximately 7 months
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Mean Change in Mindfulness from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
|
Trait decentering and curiosity, measured using 13 self-report items with Likert scale from 0 (not at all) to 5 (very much).
Trait mindfulness is calculated as an average of all items, ranging from 0 to 5, with higher scores indicating greater mindful decentering and curiosity; will also be used as a covariate or moderator.
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From enrollment, up to 3 months post-intervention
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Mean Change in Rational-Experiential Ability from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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Trait rational-experiential ability, measured using 10 self-report items with Likert scale from 1 (strongly disagree) to 6 (strongly agree).
Each subscale is calculated as an average of all of the items for each subscale, respectively.
Higher scores indicate greater rational or experiential thinking abilities.
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From enrollment, up to 3 months post-intervention
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Mean Change in Knowledge Transfer from baseline up to 3 months post-intervention assessed via Self-Report
Time Frame: From enrollment, up to 3 months post-intervention
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General self-reported learning and transfer strategies, measured using 5 self-report items with Likert scale from (strongly disagree) to 6 (strongly agree).
Physics Transfer is calculated as an average of all items, ranging from 1 to 6, with higher scores indicating greater use of learning and transfer strategies.
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From enrollment, up to 3 months post-intervention
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Treatment Expectancy assessed via Self-Report
Time Frame: 3 days post-intervention
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Perception of credibility and expected efficacy of training, measured using 4 self-report items with Likert scale from 1 (not at all) to 5 (very much).
Each subscale is calculated as an average of all of the items for each subscale, respectively.
Higher scores indicate greater perceived credibility or efficacy of the training.
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3 days post-intervention
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Intervention Attention Check Questions assessed via Ecological Momentary Assessment
Time Frame: during intervention, five days
|
Multiple choice questions gauging the attentiveness to the intervention audio.
Each item is scored for accuracy, as correct or incorrect.
|
during intervention, five days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Brian Galla, PhD, University of Pittsburgh
- Principal Investigator: Timothy Nokes-Malach, PhD, University of Pittsburgh
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)
October 3, 2022
Primary Completion (Estimated)
July 31, 2024
Study Completion (Estimated)
December 31, 2024
Study Registration Dates
First Submitted
September 12, 2022
First Submitted That Met QC Criteria
September 12, 2022
First Posted (Actual)
September 15, 2022
Study Record Updates
Last Update Posted (Actual)
May 7, 2024
Last Update Submitted That Met QC Criteria
May 5, 2024
Last Verified
May 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19050258 Part 2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Deidentified data and materials required to reproduce results reported in publications will be available to researchers.
IPD Sharing Time Frame
Data, materials, and analytic code required to reproduce results will be shared upon publication.
IPD Sharing Access Criteria
Data, materials, and analytic code will be shared on Open Science Framework (or other online repository).
IPD Sharing Supporting Information Type
- ANALYTIC_CODE
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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