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RecruitingNCT06745934SHINEUpdated Apr 2, 2025

Strengthening Health and Insight in New Educators

An interventional study of Healthy Minds Program in Anxiety Symptoms and Depressive Symptoms, sponsored by University of Alabama, Tuscaloosa. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-04-02.

Sponsored by University of Alabama, Tuscaloosa · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Mental health concerns in teachers have escalated since the onset of the pandemic, and the deterioration of mental health can begin as early as the teacher training period. Accessible and scalable programs that prepare teachers for the stress of the profession are urgently needed to prevent the deterioration of mental health and its attendant consequences. The goal of this longitudinal project is to test the feasibility and acceptability, utility, and candidate mechanisms of an accessible, mobile health, mindfulness-based intervention, the Healthy Minds Program (HMP), to equip teachers in training ("pre-service teachers"; i.e., university students majoring in education) with skills necessary to maintain their mental health as they transition into the classroom. The project addresses three specific aims. Aim 1: a) Assess the feasibility and acceptability of the HMP for pre-service teachers and b) identify barriers and facilitators to program acceptability. Aim 2: Determine the utility of the HMP for preventing depression and anxiety (main outcomes) and turnover intentions (secondary outcome). Aim 3: Examine HMP effects on candidate mechanisms, and the effect of mechanisms on outcomes. The results of this project will provide critical insight into the potential for the HMP to scale up for widespread use in pre-service teacher training programs. Importantly, the project will provide a unique opportunity for undergraduate research at the University of Alabama, and will strengthen the research environment by involving undergraduate research assistants in each step of the research process.

02

Conditions studied

  • Anxiety Symptoms
  • Depressive Symptoms

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Keywords

  • Healthy Minds Program
  • mindfulness-based intervention
  • app
  • pre-service teachers
  • mental health
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
140 participants (estimated)

Study arms

  • No intervention
    Business as Usual

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

  • Experimental
    Healthy Minds Program

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

    Behavioral: Healthy Minds Program

Interventions

  • BehavioralHealthy Minds Program

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

05

What researchers measure

Primary outcomes

  1. 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).

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

  2. 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).

    Time frame: 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 self-report on their intentions to leave their job.

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

Other outcomes

  1. Teaching Quality: edTPA

    Performance-based assessment of teaching quality required for teacher certification. Higher scores indicate greater teaching quality.

    Time frame: edTPA scores will be collected immediately after the intervention.

  2. Teaching Quality: Candidate Preservice Assessment of Student Teaching (CPAST)

    Summative assessment of pre-service teachers' teaching quality during the semester-long student teaching experience. Higher scores indicate greater teaching quality.

    Time frame: CPAST scores will be collected immediately after the intervention.

06

Study locations

1 of 1 sites recruiting
  • University of Alabama
    Tuscaloosa, Alabama 35487, United States
    Recruiting
07

Registry details

Key details

Study ID
NCT06745934
Lead sponsor
University of Alabama, Tuscaloosa
Collaborators
National Institute of Mental Health (NIMH)
Responsible party
Summer Braun (Assistant Professor, University of Alabama, Tuscaloosa) — Principal investigator
First posted
Dec 20, 2024
Start date
Jan 17, 2025
Primary completion
Jun 2027 (estimated)
Completion
Jun 2027 (estimated)
Last update
Apr 2, 2025

Study contacts

Summer S Braun, Ph.D.
Contact
ssbraun@ua.edu
2053486159
Alison L Hooper, Ph.D.
Contact
alhooper2@ua.edu
205-348-0303

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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