Mindfulness App for Depression and Anxiety

(SHINE Trial)

Overseen By Alison L Hooper, Ph.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alabama, Tuscaloosa

Disqualifiers: Not in Block 3, Suicidal ideations

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

140 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mindfulness app can prevent depression and anxiety in teachers starting their careers. Teachers in their final year of training will use the Healthy Minds Program app, while a comparison group will maintain their usual routines. The study specifically seeks student teachers in their third block of training who do not have moderate or high-risk suicidal thoughts. By examining the app's potential benefits for teachers, the study aims to support mental health during this crucial career transition. As an unphased trial, it offers teachers a unique opportunity to contribute to research that could improve mental health support during their career transition.

Do I need to stop my current medications to join the trial?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that the Healthy Minds Program app is safe for teachers?

Research shows that the Healthy Minds Program, a meditation app, is generally safe for users. Studies have found that using this app for just five minutes a day can significantly reduce stress and anxiety. For example, one study reported a 28% drop in stress levels and an 18% decrease in anxiety. Additionally, more research suggests that meditation apps like the Healthy Minds Program consistently help reduce symptoms of depression.

No reports of serious side effects have emerged from using the app, indicating that most people tolerate it well. As a mindfulness app, the Healthy Minds Program doesn't involve medication or physical treatments, often making it a safer option for many people. Overall, these findings suggest that the Healthy Minds Program is a safe choice for those looking to improve their mental well-being. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Healthy Minds Program because it offers a novel approach to managing depression and anxiety through a mindfulness app. Unlike traditional treatments like medication and therapy, which require in-person interaction or prescription management, this app provides a convenient, self-guided experience accessible anytime via a smartphone. The program focuses on cultivating mindfulness and emotional well-being, which could empower users to proactively manage their mental health. This innovative delivery method makes mental health support more accessible and flexible, which could be particularly beneficial for individuals with busy schedules or limited access to traditional care.

What evidence suggests that the Healthy Minds Program app is effective for preventing depression and anxiety in teachers?

Research has shown that the Healthy Minds Program app, available to participants in this trial, can reduce stress and improve well-being. In one study, over 70% of users experienced a noticeable decrease in depression symptoms. Other research indicates that self-guided mental health apps like this one can help prevent depression. The app emphasizes mindfulness and addresses other mental health areas, enhancing its effectiveness. Overall, these findings suggest the app may benefit teachers managing stress and anxiety. Participants in the other arm of this trial will continue with their usual daily routines. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

This trial is for final-year teacher trainees at risk of depression and anxiety. Participants must be willing to use an app-based mindfulness program designed to help maintain their mental health as they transition into teaching roles.

Inclusion Criteria

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

Exclusion Criteria

Students who are not in Block 3 will be excluded.

I am not at moderate or high risk of suicide according to a clinical assessment.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage with the Healthy Minds Program app to prevent mental health deterioration

3 months

App-based engagement

Follow-up

Participants are monitored for anxiety, depression, and turnover intentions

12 months

Assessments at 3-month and 12-month intervals

What Are the Treatments Tested in This Trial?

Interventions

• Healthy Minds Program

Trial Overview

The 'Healthy Minds Program' app is being tested to see if it can prevent worsening mental health in teachers entering the workforce. The study involves using the app regularly and monitoring its effects on participants' well-being.

How Is the Trial Designed?

Group I: Healthy Minds Program Experimental Treatment 1 Intervention

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

Group II: Business as Usual Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Alabama, Tuscaloosa

Lead Sponsor

Trials

49

Recruited

17,900+

National Institute of Mental Health (NIMH)

Collaborator

Trials

3,007

Recruited

2,852,000+

Published Research Related to This Trial

A meta-analysis of 45 randomized controlled trials involving over 11,000 participants found that mindfulness apps significantly reduce symptoms of depression (effect size g = 0.24) and anxiety (effect size g = 0.28) compared to control groups.

While mindfulness apps show promise for reducing symptoms, they did not demonstrate significant advantages over other active therapeutic interventions, indicating the need for higher quality studies with longer follow-up periods to better understand their efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The efficacy of mindfulness apps on symptoms of depression and anxiety: An updated meta-analysis of randomized controlled trials. Linardon, J., Messer, M., Goldberg, SB., et al.[2023]

A study involving 191 participants using the VGZ Mindfulness Coach app showed significant improvements in mindfulness and reductions in psychiatric symptoms after 8 weeks, with a large effect size (Cohen's d = 0.77).

The benefits of using the app, including enhanced quality of life and sustained improvements in mindfulness facets, were maintained for at least 3 months, indicating its potential as a low-cost, effective tool for mental well-being.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. van Emmerik, AAP., Berings, F., Lancee, J.[2020]

In a 21-day mindfulness-based intervention with 82 participants, 87% reported at least one momentary adverse effect during meditation, primarily anxiety, indicating that mindfulness practice can sometimes lead to temporary increases in anxiety.

Despite these momentary effects, 25% of participants experienced sustained adverse effects in daily life after the intervention, but these were not linked to the momentary effects during meditation, suggesting that increased awareness of internal states may contribute to these post-intervention challenges.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. Aizik-Reebs, A., Shoham, A., Bernstein, A.[2021]

A review of 27 popular mental health apps for depression and anxiety revealed that while 23 apps included evidence-based therapeutic elements, many core components of effective psychotherapy, such as cognitive restructuring and problem solving, were significantly underrepresented.

Common elements like psychoeducation, relaxation, and mindfulness were present in many apps, but the lack of critical treatment strategies suggests a need for further research and randomized trials to evaluate the effectiveness of these apps in delivering comprehensive mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. Wasil, AR., Venturo-Conerly, KE., Shingleton, RM., et al.[2020]

Mindfulness training led to significant improvements in psychological symptoms and quality of life for a diverse group of 143 psychiatric outpatients, indicating its overall efficacy as a therapeutic intervention.

However, patients with bipolar disorder did not show significant improvement, which may be linked to their longer illness duration and lower baseline severity compared to other diagnostic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. Bos, EH., Merea, R., van den Brink, E., et al.[2019]

A therapeutic education program based on mindfulness was developed in the 1990s to help combat depression and generalized anxiety disorder, focusing on being present without judgment.

In France, this program will be implemented in psychiatry, using meditation and psychoeducation to help patients with depression detach from their psychological and emotional content.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Treating depression through mindfulness-based cognitive therapy]. Dulong, F.[2018]

A 4-week randomized controlled trial involving 561 university students and staff found that using a mindfulness app led to small reductions in stress and depression, with effect sizes of 0.16 for both outcomes.

Despite a 28% dropout rate, the study suggests that mindfulness apps can provide modest but clear benefits for mental health, making them a promising supplement to traditional mental health services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effects of app-based mindfulness practice on the well-being of university students and staff. Lahtinen, O., Aaltonen, J., Kaakinen, J., et al.[2023]

In a study involving 144 patients with bipolar disorder undergoing Mindfulness-Based Cognitive Therapy (MBCT), adverse effects (AEs) were reported by 29 patients, with most occurring within the first three weeks and decreasing thereafter.

Despite the occurrence of AEs, most patients viewed them as part of a therapeutic process rather than harmful, indicating that while AEs are present, they are generally not serious and can be perceived positively in the context of treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. Hanssen, I., Scheepbouwer, V., Huijbers, M., et al.[2021]

A survey of 129 stakeholders across 20 healthcare regions in Sweden revealed that while Mindfulness-Based Programs (MBPs) are being implemented, there is significant variation in the models used and modifications to evidence-based practices.

Key factors for successful MBP implementation include having a supportive leader and a champion for the program, while challenges such as time constraints and funding shortages hinder effective rollout.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. Niemi, M., Crane, R., Sinselmeijer, J., et al.[2022]

A randomized controlled trial showed that a 2-week mobile health program based on cognitive-behavioral therapy (CBT) effectively reduced anxiety and depressive symptoms, although it did not outperform a control group focused on procrastination.

Higher engagement with the mHealth app was linked to greater reductions in anxiety and depressive symptoms, with psychological mindedness acting as a key mediator in this relationship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Intellect's self-guided anxiety and worry mobile health programme: A randomized controlled trial with an active control and a 2-week follow-up. Kosasih, FR., Yee, VTS., Toh, SHY., et al.[2023]

A mixed-methods feasibility study involving 54 participants showed that a blended intervention using the mindfulness app Headspace with clinician support is feasible and acceptable for treating moderate to moderately severe depression.

Participants who engaged more with the Headspace sessions experienced a significant reduction in depression symptoms, with a notable effect size of d = 0.69, indicating potential effectiveness, though further research is needed to confirm these findings and explore long-term impacts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study. Strauss, C., Dunkeld, C., Cavanagh, K.[2021]

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