NCT06745934

Brief Summary

Teachers are at notable risk for depression and anxiety. The present study tests an app-based mindfulness intervention for teachers in their final year of training with the goal of preventing the deterioration of their mental health during the transition into the classroom. The project will strengthen the research environment at the University of Alabama and will involve undergraduate research assistants in each step of the research process.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
13mo left

Started Jan 2025

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress55%
Jan 2025Jun 2027

First Submitted

Initial submission to the registry

December 12, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 20, 2024

Completed
28 days until next milestone

Study Start

First participant enrolled

January 17, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

April 2, 2025

Status Verified

March 1, 2025

Enrollment Period

2.4 years

First QC Date

December 12, 2024

Last Update Submit

March 31, 2025

Conditions

Keywords

Healthy Minds Programmindfulness-based interventionapppre-service teachersmental health

Outcome Measures

Primary Outcomes (2)

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Depression - Short Form 8b

    Participants will self-report on depression. Each of the 8 items is rated on 1 (1 = Never) to 5 (5 = Always) scale. Responses will be summed to create the raw scale score. Higher values indicate greater symptoms of depression (i.e., a worse outcome).

    Participants will report on depression at baseline, post-intervention (3 months after baseline), 3-month follow-up , and 12-month follow-up.

  • Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety - Short Form 7a

    Participants will self-report on anxiety. Each of the 7 items is rated on 1 (1 = Never) to 5 (5 = Always) scale. Responses will be summed to create the raw scale score. Higher values indicate greater symptoms of anxiety (i.e., a worse outcome).

    Participants will report on anxiety at baseline, post-intervention (3 months after baseline), 3-month follow-up, and 12-month follow-up.

Secondary Outcomes (1)

  • Turnover Intentions

    Participants will report turnover intentions at 3-month follow-up, and 12-month follow-up.

Other Outcomes (2)

  • Teaching Quality: edTPA

    edTPA scores will be collected immediately after the intervention.

  • Teaching Quality: Candidate Preservice Assessment of Student Teaching (CPAST)

    CPAST scores will be collected immediately after the intervention.

Study Arms (2)

Business as Usual

NO INTERVENTION

Participants in this arm will continue with daily life as usual.

Healthy Minds Program

EXPERIMENTAL

Participants in this arm engage with the Healthy Minds Program app.

Behavioral: Healthy Minds Program

Interventions

Participants in this arm engage with the Healthy Minds Program app/

Healthy Minds Program

Eligibility Criteria

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

You may qualify if:

  • Students in Block 3 will be invited to participate in the study.

You may not qualify if:

  • Students who are not in Block 3 will be excluded. Participants experiencing suicidal ideations at baseline and deemed via the clinical risk assessment procedure to be at moderate or high risk of suicide will be excluded from the study after baseline, and prior to randomization.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama

Tuscaloosa, Alabama, 35487, United States

RECRUITING

MeSH Terms

Conditions

Anxiety DisordersDepressionAlzheimer DiseasePsychological Well-Being

Condition Hierarchy (Ancestors)

Mental DisordersBehavioral SymptomsBehaviorDementiaBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersPersonal Satisfaction

Central Study Contacts

Summer S Braun, Ph.D.

CONTACT

Alison L Hooper, Ph.D.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

December 12, 2024

First Posted

December 20, 2024

Study Start

January 17, 2025

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

April 2, 2025

Record last verified: 2025-03

Locations