NCT05542498

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
303

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 12, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

October 3, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 12, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 10, 2025

Status Verified

January 1, 2025

Enrollment Period

1.8 years

First QC Date

September 12, 2022

Last Update Submit

January 8, 2025

Conditions

Keywords

MindfulnessPhysics EducationPsychological Challenge and ThreatEngagementMotivationRelaxation

Outcome Measures

Primary Outcomes (4)

  • Mean Change in Daily Physics Emotions from baseline up to 1 week post-intervention assessed via Daily Diary Self-Report

    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.

    From enrollment up to 1 week post-intervention

  • Mean Change in Daily Responses to Physics Emotions from baseline up to 1 week post-intervention assessed via Daily Diary Self-Report

    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

    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

    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.

    From enrollment up to 1 week post-intervention

Secondary Outcomes (19)

  • State Presence assessed via Ecological Momentary Assessment

    during intervention, five days

  • State Relaxation assessed via Ecological Momentary Assessment

    during intervention, five days

  • State Physics Anxiety assessed via Ecological Momentary Assessment

    during intervention, five days

  • Mean Change in Physics Anxiety from baseline up to 3 months post-intervention assessed via Self-Report

    From enrollment, up to 3 months post-intervention

  • Mean Change in Psychological Threat vs. Challenge from baseline up to 3 months post-intervention assessed via Self-Report

    From enrollment, up to 3 months post-intervention

  • +14 more secondary outcomes

Other Outcomes (7)

  • Performance in Physics Class

    End of semester following intervention, approximately 12 weeks

  • Retention in Physics Classes

    End of semester following intervention, approximately 7 months

  • Mean Change in Mindfulness from baseline up to 3 months post-intervention assessed via Self-Report

    From enrollment, up to 3 months post-intervention

  • +4 more other outcomes

Study Arms (2)

Mindfulness Training

ACTIVE COMPARATOR

5-lesson audio-guided mindfulness training program delivered over 5 consecutive days, with two additional writing activities on day 1 and day 5

Behavioral: Mindfulness

Relaxation Training

ACTIVE COMPARATOR

5-lesson audio-guided relaxation training program delivered over 5 consecutive days, with two additional writing activities on day 1 and day 5

Behavioral: Relaxation

Interventions

MindfulnessBEHAVIORAL

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.

Mindfulness Training
RelaxationBEHAVIORAL

Training is focused on learning and applying relaxation practices (e.g., progressive muscle relaxation, guided imagery) in the context of physics learning.

Relaxation Training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • at least 18 years of age
  • current University of Pittsburgh undergraduate
  • enrolled in introductory physics
  • self-reports psychological threat in physics

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

MeSH Terms

Conditions

Stress, PsychologicalEmotional Regulation

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial Behavior

Intervention Hierarchy (Ancestors)

Cognitive Behavioral TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Brian Galla, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR
  • Timothy Nokes-Malach, PhD

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 12, 2022

First Posted

September 15, 2022

Study Start

October 3, 2022

Primary Completion

July 12, 2024

Study Completion

December 31, 2024

Last Updated

January 10, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will share

Deidentified data and materials required to reproduce results reported in publications will be available to researchers.

Shared Documents
ANALYTIC CODE
Time Frame
Data, materials, and analytic code required to reproduce results will be shared upon publication.
Access Criteria
Data, materials, and analytic code will be shared on Open Science Framework (or other online repository).

Locations