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

Trial Summary

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 data supports the effectiveness of the treatment Healthy Minds Program for depression and anxiety?

Research shows that mindfulness apps, similar to the Healthy Minds Program, can help reduce symptoms of depression and anxiety. A meta-analysis found small but significant improvements in these symptoms when using mindfulness apps compared to control groups, suggesting they can be a helpful tool for mental health. ^{1 2 3 4 5}

Is the Mindfulness App for Depression and Anxiety safe for humans?

Research on mindfulness apps, like the VGZ Mindfulness Coach and Headspace, suggests they are generally safe for humans, with no significant adverse effects reported. However, some studies highlight the need for more research to fully understand any potential negative effects. ^{1 5 6 7 8}

How does the Healthy Minds Program treatment differ from other treatments for depression and anxiety?

The Healthy Minds Program is unique because it uses a mindfulness app to help reduce symptoms of depression and anxiety, offering a convenient and accessible way to practice mindfulness. Unlike traditional therapies that may require in-person sessions, this app-based approach allows users to engage in mindfulness practices at their own pace and convenience, making it a flexible option for improving mental health. ^{3 4 9 10 11}

What is the purpose of this trial?

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.

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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 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]

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 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 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]

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 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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

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

2. England pubmed.ncbi.nlm.nih.gov

A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. [2020]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

The efficacy of mindfulness apps on symptoms of depression and anxiety: An updated meta-analysis of randomized controlled trials. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]

8. England pubmed.ncbi.nlm.nih.gov

First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]

9. France pubmed.ncbi.nlm.nih.gov

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

10. United States pubmed.ncbi.nlm.nih.gov

The effects of app-based mindfulness practice on the well-being of university students and staff. [2023]

11. United States pubmed.ncbi.nlm.nih.gov

The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. [2022]