Mindfulness App for Depression and Anxiety
(SHINE Trial)
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Alabama, Tuscaloosa
Disqualifiers: Not in Block 3, Suicidal ideations
No Placebo Group
Trial Summary
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.
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.
12345Is 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.
15678How 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.
3491011Eligibility 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.
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: Healthy Minds ProgramExperimental Treatment1 Intervention
Participants in this arm engage with the Healthy Minds Program app.
Group II: Business as UsualActive Control1 Intervention
Participants in this arm will continue with daily life as usual.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
University of AlabamaTuscaloosa, AL
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Who Is Running the Clinical Trial?
University of Alabama, TuscaloosaLead Sponsor
National Institute of Mental Health (NIMH)Collaborator
References
Is clinician-supported use of a mindfulness smartphone app a feasible treatment for depression? A mixed-methods feasibility study. [2021]Depression is the leading cause of disability globally and has serious consequences for the individual, their family and for society. Effective, accessible and affordable treatments are urgently needed. In-person group-based mindfulness-based interventions are an effective treatment for depression, but are not widely available and can be costly. Clinician supported use of mindfulness self-help resources such as mindfulness smartphone applications could widen access at a reduced cost, but there are key feasibility questions that need answering. This is a mixed-methods feasibility study of a blended intervention involving the mindfulness smartphone app Headspace alongside six clinician support sessions with mental health treatment seeking adults experiencing moderate to moderately severe symptoms of depression. In line with recommendations for feasibility studies, we examine whether: (1) it is possible to recruit participants to this novel intervention, (2) participants engage with the intervention, (3) participants and clinicians find the intervention acceptable, and (4) pre-post outcomes on measures of depression (primary outcome), anxiety, wellbeing, mindfulness, self-compassion, rumination and worry indicate effectiveness. Findings show that recruitment is feasible with 54 participants enrolled in the intervention within a 6-month window. In terms of engagement, 44.4% completed at least 80% of recommended Headspace sessions and 72.2% of participants attended at least three clinician support sessions. Clinician-supported Headspace was deemed acceptable by participants and clinicians. Pre-post effect sizes were statistically significant and in the small-medium or medium-large range on all outcomes, with an effect size of d = 0.69 (95% CI: 0.34-1.04) for the primary outcome of depression symptom severity. The number of Headspace sessions engaged with was associated with greater reduction in depression symptom severity. Findings suggest that a blended intervention combining Headspace with clinician support has potential as a first-line treatment for moderate/moderately severe depression, but findings are too preliminary to recommend the intervention outside of a research trial. Important caveats are noted including the need for future research to examine predictors of engagement with Headspace sessions so that engagement can be enhanced, to measure the longer term effects of such interventions and to better understand the potential for lasting negative effects of the intervention so that these can be minimised.
A review of popular smartphone apps for depression and anxiety: Assessing the inclusion of evidence-based content. [2020]Smartphone applications for the treatment of depression and anxiety have acquired millions of users, yet little is known about whether they include evidence-based therapeutic content. We examined the extent to which popular mental health applications (MH apps) for depression and anxiety contain treatment elements found in empirically supported psychotherapy protocols (i.e., "common elements"). Of the 27 MH apps reviewed, 23 included at least one common element, with a median of three elements. Psychoeducation (in 52% of apps), relaxation (44%), meditation (41%), mindfulness (37%), and assessment (37%) were the most frequent elements, whereas several elements (e.g., problem solving) were not found in any apps. We also identified gaps between app content and empirically supported treatments. Cognitive restructuring was more common in depression protocols than in depression apps (75% of protocols vs. 31% of apps), as was problem solving (34% vs. 0%). For anxiety, exposure (85%, 12%), cognitive restructuring (60%, 12%), and problem solving (25%, 0%) were more common in protocols than apps. Overall, our findings highlight empirically supported treatment elements that are poorly represented in current MH apps. The absence of several core treatment elements underscores the need for future research, including randomized trials testing the effectiveness of popular MH apps.
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]Digital self-guided mobile health [mHealth] applications are cost-effective, accessible, and well-suited to improve mental health at scale. This randomized controlled trial [RCT] evaluated the efficacy of a recently developed mHealth programme based on cognitive-behavioral therapy [CBT] principles in improving worry and anxiety. We also examined psychological mindedness [PM] as a mediator by which app engagement is thought to improve outcomes. The Intervention group completed a 2-week "Anxiety and Worry" programme with daily CBT-informed activities, while the active waitlist-control completed a matched 2-week mHealth programme on procrastination. Participants filled out the Generalized Anxiety Disorder [GAD-7], Patient Health Questionnaire [PHQ-9], and Psychological Mindedness Scale [PMS] at baseline, post-intervention, and 2-week follow-up. App engagement was measured at post-intervention only. Contrary to prediction, the Intervention group did not perform better than the Active Control group; both groups showed significant improvements on anxiety and depressive symptoms from baseline to follow-up. From post-intervention to follow-up, only the Intervention group showed further improvements for anxiety symptoms. Higher engagement with the mHealth app predicted lower anxiety and depressive symptoms at follow-up, and this relationship was fully mediated by psychological mindedness. This study provides evidence that [a] engaging in a CBT mHealth programme can reduce anxiety and worry, and [b] Psychological mindedness is a potential pathway by which engaging with a mHealth app improves anxiety and depressive symptoms. While overall effect sizes were small, at the population level, these can make significant contributions to public mental health.
The efficacy of mindfulness apps on symptoms of depression and anxiety: An updated meta-analysis of randomized controlled trials. [2023]Mindfulness apps have become popular tools for addressing symptoms of depression and anxiety. Since the publication of earlier meta-analyses evaluating the efficacy of mindfulness apps for depression and anxiety symptoms, over 20 randomized controlled trials (RCTs) have been conducted. There is a need for an updated meta-analysis that quantifies the effects of mindfulness apps on these symptoms and tests for potential moderators.. Random effects meta-analyses were conducted on 45 RCTs. Small, significant effect sizes were found for symptoms of depression (Ncomp = 46, N = 5852, g = 0.24, 95% CI = 0.17, 0.31, NNT = 13.57) and anxiety (Ncomp = 48, N = 6082, g = 0.28, 95% CI = 0.21, 0.35, NNT = 11.47) in favour of mindfulness apps over control groups. This effect was not explained by symptom deterioration in participants allocated to control groups. Effects remained stable when restricting analyses to lower risk of bias and larger sample trials. No significant moderators were observed, except trials that offered monetary compensation produced larger effects on depression. Non-significant effects were observed when comparing mindfulness apps to active therapeutic comparisons (g = -0.15 depression, g = 0.10 anxiety), though the number of studies was low. Growing evidence indicates that mindfulness apps can acutely reduce symptoms of depression and anxiety, although higher quality studies with longer follow-ups are needed.
Mindfulness training in a heterogeneous psychiatric sample: outcome evaluation and comparison of different diagnostic groups. [2019]To examine outcome after mindfulness training in a heterogeneous psychiatric outpatient population and to compare outcome in different diagnostic groups.
Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. [2020]Although several hundreds of apps are available that (cl)aim to promote mindfulness, only a few methodologically sound studies have evaluated the efficacy of these apps. This randomized waiting-list controlled trial therefore tested the hypothesis that one such app (the VGZ Mindfulness Coach) can achieve immediate and long-term improvements of mindfulness, quality of life, general psychiatric symptoms, and self-actualization. One hundred ninety-one experimental participants received the VGZ Mindfulness Coach, which offers 40 mindfulness exercises and background information about mindfulness without any form of therapeutic guidance. Compared to 186 control participants, they reported large (Cohen's d = 0.77) and statistically significant increases of mindfulness after 8 weeks and small-to-medium increases of the Observing, Describing, Acting with awareness, Nonjudging, and Nonreactivity mindfulness facets as measured with the Five Facet Mindfulness Questionnaire (Cohen's d = 0.66, 0.26, 0.49, 0.34, and 0.43, respectively). Also, there were large decreases of general psychiatric symptoms (GHQ-12; Cohen's d = -0.68) and moderate increases of psychological, social, and environmental quality of life (WHOQOL-BREF; Cohen's d = 0.38, 0.38, and 0.36, respectively). Except for social quality of life, these gains were maintained for at least 3 months. We conclude that it is possible to achieve durable positive effects on mindfulness, general psychiatric symptoms, and several aspects of quality of life at low costs with smartphone apps for mindfulness such as the VGZ Mindfulness Coach.
Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]Mindfulness-Based Interventions (MBIs) are widely used in clinical and non-clinical populations, but little attention has been given to potential adverse effects (AEs).
First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]The study of safety and adverse effects of mindfulness-based interventions (MBIs) is limited. We propose a novel reliable change index (RCI) approach to experience sampling (ES) data to begin to understand the common domains, frequency, severity, risk for, and context of adverse responding to mindfulness meditation practice and brief MBI.
[Treating depression through mindfulness-based cognitive therapy]. [2018]Mindfulness is the art of being fully present in what we are doing, without judgement and without expectation. A therapeutic education programme was created in the 1990s in order to combat depression and generalised anxiety disorder. In France, this programme will be used in psychiatry. Meditation and psychoeducation will enable patients with depression to gradually establish a detachment with regard to the psychological and emotional content.
The effects of app-based mindfulness practice on the well-being of university students and staff. [2023]Mental health problems like anxiety, depression, and stress have been increasing in many countries and the 2020 COVID-19 pandemic has further exacerbated their toll. Mindfulness-based interventions have been shown to provide evidence-based treatments for anxiety and depression, and accumulating evidence is emerging in support of using mindfulness apps yielding small-to-moderate treatment effects. The study was a 4-week randomized controlled trial with 561 university students and staff as participants, divided into a treatment group (mindfulness app) and an active control group (psychoeducational online content). Depression, anxiety, and stress were evaluated as primary study outcomes. Saliva cortisol samples were also collected from a subgroup of the treatment arm (n = 29). Using the mindfulness app for four weeks resulted in small reductions in stress (d = .16), and depression (d = .16). Attrition was 28.0%. Subjects who practiced more did not experience additional improvement in wellbeing. Mindfulness apps offer modest but clear benefits to users in terms of improved mental health. They present a promising supplement to traditional mental health services.
The Implementation of Mindfulness-Based Programs in the Swedish Healthcare System - A Survey Study of Service Providers. [2022]The burden of depression and anxiety is on the rise globally. Mindfulness-Based Programs (MBPs) are a particular group of psychosocial programs targeting depression and anxiety. There is growing research and practice interest in MBPs internationally, and they are becoming more commonly implemented in a number of countries' healthcare services.