Mobile Health Mindfulness for Anxiety

Recruiting at 2 trial locations

Overseen By ELISSA KOZLOV, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Mindfulness therapy, Cognitive impairment, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 8

Duration: 6 months

162 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help older adults with serious illnesses and their caregivers manage anxiety using a mindfulness app. Participants will use either a mindfulness training app (Mindfulness Coach) or a general health app to determine which is more effective in reducing anxiety. The trial seeks individuals aged 60 and older who have a serious illness, such as cancer or COPD, or caregivers who provide primary care for such individuals. Participants should not have used mindfulness therapy in the past two years and must be able to use a mobile device. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could improve anxiety management for many.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on a mindfulness intervention for anxiety, which is non-pharmacological (does not involve medication).

What prior data suggests that this mindfulness intervention is safe for older adults with serious illness and their caregivers?

Research on mindfulness apps like the Mindfulness Coach shows they are generally safe, with no major side effects reported. This app helps users practice mindfulness and has been shown to slightly reduce anxiety. Studies have found that users tolerate it well, making it a safe choice for managing anxiety symptoms. Although specific data on side effects in clinical settings is limited, existing research on similar apps supports their safety for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Mobile Health Mindfulness treatment for anxiety because it leverages a new delivery method: a mobile app designed for mindfulness training. Unlike standard care options like medication or traditional therapy sessions, this app offers a self-guided, interactive experience with 14 sequential levels that include guided meditations and mindfulness exercises. Developed by the VA's National Center for PTSD, the app is accessible on both iOS and Android, making it available to a wide range of users. This digital approach not only provides flexibility and convenience but also incorporates evidence-based practices that can be personalized to fit the user's pace and needs.

What evidence suggests that this trial's treatments could be effective for anxiety?

Research has shown that mindfulness-based activities can help reduce anxiety. One study found these activities to be as effective as cognitive behavioral therapy, a common treatment for anxiety. Another review indicated that mindfulness practices significantly lowered anxiety, depression, and stress. Mindfulness-based stress reduction proved as effective as escitalopram, a common anxiety medication. Participants often experience better emotional control and increased self-awareness. In this trial, participants will use the Mindfulness Coach app, which employs these methods, to manage anxiety in older adults and their caregivers. Meanwhile, the control group will use the WebMD app as an attention control. ^{6 7 8 9 10}

Who Is on the Research Team?

Elissa Kozlov, PhD

Principal Investigator

Rutgers University

Are You a Good Fit for This Trial?

This trial is for English-speaking adults over 60 with serious illnesses like cancer or heart disease, and their caregivers who are 21+. Participants must be new to mindfulness therapy, have anxiety (Hads-A > 8), and be able to use mobile devices without vision or hearing issues. Those with significant cognitive impairment or prior mindfulness experience are excluded.

Inclusion Criteria

Hads-A > 8 for patient or caregiver

Caregiver blessed <6

Caregiver is fluent in English

Exclusion Criteria

Cognitive impairment more than 6 on Blessed.

Vision or hearing that impairs use of mobile device

I am not fluent in English.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the Mindfulness Coach app, completing 14 sequential levels with psychoeducation and mindfulness exercises

6 months

4 app interactions per week

Control

Participants use the WebMD app as an attention control, accessing it 4 times per week

6 months

4 app interactions per week

Follow-up

Participants are monitored for safety and effectiveness after treatment

8 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Active Comparator
• Mindfulness Coach

Trial Overview

The study tests a mobile health (mHealth) mindfulness program aimed at reducing anxiety in older patients with serious illness and their primary caregivers. It compares the effectiveness of a Mindfulness Coach intervention against an active comparator in a primary care setting.

How Is the Trial Designed?

Group I: mindfulness coach Experimental Treatment 1 Intervention

Mindfulness coach is an app that provides a training plan with 14 sequential levels, a "practice now" area with evidence-based mindfulness audio exercises, assessments using the Five-Factor Mindfulness Questionnaire Short Form (FFMQ-SF)90, and education about mindfulness an iOS- and Android-based app designed to deliver a mindfulness training course centered on Veteran's Affairs (VA) protocols. Developed by the VA's National Center for PTSD, the app provides an engaging introduction to MT, regardless of specific psychiatric illness or patient population. . To progress to the next level, the user must interact with every element. The training plan levels include psychoeducation and exercises (guided meditations and seated practices), which increase in duration as users progress. Levels 1,7 and 14 also include an assessment with the FFMQ-SF. The "practice now" area has guided meditations to practice new skills.

Group II: control - web MD Active Control 1 Intervention

A a widely available health and wellness app that provides users with daily content on general health, WebMD, will serve as the attention control. Similar health-based apps have been used as controls in other mHealth psychotherapy intervention trials.100,101 The control group will be instructed to access the app 4x/week (same as intervention group) and will receive an orientation and 2 booster sessions as well. I considered other control group options including treatment as usual, but attention control was selected due to the variability of treatment as usual.

Mindfulness Coach is already approved in United States, European Union, Switzerland for the following indications:

Approved in United States as Mindfulness Coach for:

• Anxiety management in older adults with serious illness and their caregivers

Approved in European Union as Mindfulness-Based Stress Reduction for:

• Stress reduction
• Anxiety management
• Depression management

Approved in Switzerland as Mindfulness Meditation for:

• Anxiety management in patients with cancer
• Distress management in patients with cancer

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Published Research Related to This Trial

Mindfulness meditation (MM) can have side effects, particularly related to mental health, physical health, and spiritual well-being, highlighting the need for safety considerations in research.

The paper provides practical tools for researchers, including screening procedures to assess participant contraindications and guidelines for MM training, based on a review of 17 primary studies and 5 secondary reports on meditation side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness meditation research: issues of participant screening, safety procedures, and researcher training. Lustyk, MK., Chawla, N., Nolan, RS., et al.[2022]

Mobile mindfulness meditation (MMM) significantly reduces stress and anxiety among university students, with a standardized mean difference of -0.41 for stress and -0.29 for anxiety, based on a meta-analysis of 10 studies involving 958 participants.

MMM also enhances well-being and mindfulness, showing a positive effect size of 0.30 for well-being and a remarkable 2.66 for mindfulness, although it did not significantly impact resilience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of Mobile Mindfulness Meditation on the Mental Health of University Students: Systematic Review and Meta-analysis. Chen, B., Yang, T., Xiao, L., et al.[2023]

Mindfulness-based interventions (MBIs) are effective in reducing symptom severity in major depressive disorder and lowering relapse rates during maintenance treatment, based on a review of 52 studies.

MBIs, particularly mindfulness-based stress reduction, have shown effectiveness in improving symptoms and quality of life in veterans with PTSD, and they are considered safe and cost-effective adjuncts to standard care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Emerging Role of Mindfulness Meditation as Effective Self-Management Strategy, Part 1: Clinical Implications for Depression, Post-Traumatic Stress Disorder, and Anxiety. Khusid, MA., Vythilingam, M.[2018]

Over the past two decades, there has been a significant increase in randomized controlled trials (RCTs) on mindfulness, with 1389 publications showing a near-exponential growth, particularly in the United States, United Kingdom, and Netherlands.

The most common mindfulness modalities studied include acceptance-based therapy and mindfulness-based stress reduction, with a notable rise in remote delivery methods, indicating a shift towards more accessible mindfulness interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized Controlled Trials of Mindfulness and Acceptance-Based Interventions Over the Past Two Decades: A Bibliometric Analysis. Ma, Y., Kraemer, KM., Lyu, J., et al.[2022]

Mindfulness-based approaches have been shown to effectively prevent depressive relapse and recurrence, leading to their recommendation by the UK's National Institute for Health and Clinical Excellence for use in the National Health Service.

There is growing evidence that mindfulness can also benefit individuals with anxiety disorders and chronic physical health issues, prompting interest in its application for other conditions like personality disorders and substance abuse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Training Teachers to Deliver Mindfulness-Based Interventions: Learning from the UK Experience. Crane, RS., Kuyken, W., Hastings, RP., et al.[2022]

Mindfulness training, which includes group instruction in various meditation styles, helps individuals focus on their present experiences without being overwhelmed by negative thoughts.

There is growing evidence that incorporating mindfulness training into chronic disease management can reduce psychological distress and enhance the quality of life for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness training: an adjunctive role in the management of chronic illness? Monshat, K., Castle, DJ.[2019]

Mindfulness practices have been shown to effectively reduce chronic pain, anxiety, and depression symptoms, while also enhancing immune function, indicating its broad therapeutic potential.

There is a dose-response relationship where more mindfulness practice leads to greater reductions in stress and mood symptoms, along with beneficial changes in brain structure and function.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Health effects of mindfulness - what should the doctor know? Raevuori, A.[2018]

A mindfulness-based mobile health intervention significantly reduced anxiety symptoms among young adult students during quarantine, showing a superior effect compared to a social support-based intervention (p = .024, between-group d = 0.72).

Both interventions improved depression symptoms, but mindfulness showed a trend towards greater benefit, and it was found to be more feasible and acceptable for participants, with high retention rates (>80%) in both groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mindfulness-based mobile health (mHealth) intervention among psychologically distressed university students in quarantine during the COVID-19 pandemic: A randomized controlled trial. Sun, S., Lin, D., Goldberg, S., et al.[2023]

Anxiety disorders are highly prevalent, highlighting the urgent need for effective non-drug treatments, particularly to address core symptoms like excessive worry.

Mindfulness training, which helps individuals become more aware of their thoughts and feelings, has shown promise in reducing anxiety, and new mobile health platforms could make this treatment more accessible and scalable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Approaching Anxiety Like a Habit Lead to Novel Treatments? Brewer, JA., Roy, A.[2022]

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 randomized controlled trial involving 587 participants found that an 8-week mindfulness mobile app did not significantly reduce perceived stress levels compared to a control group.

However, the experimental group reported significantly lower emotional and physical exhaustion after 8 weeks, suggesting potential benefits of the app in reducing burnout symptoms, although these effects were not maintained at the 6-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of a Nonguided Mindfulness App on Perceived Stress in a Nonclinical Dutch Population: Randomized Controlled Trial. Kranenburg, LW., Gillis, J., Mayer, B., et al.[2022]

Mindfulness-based stress reduction (MBSR) has been shown to improve mental health and reduce symptoms of stress, anxiety, and depression across 31 randomized studies involving both clinical and non-clinical populations.

The implementation of MBSR in the healthcare system is recommended to be gradual, ensuring that MBSR teachers in Denmark receive adequate training and education.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Effect of mindfulness on symptoms of stress, anxiety and depression]. Fjorback, LO., Rasmussen, BH., Preuss, T.[2019]

Mindfulness meditation, particularly through programs like Mindfulness-Based Stress Reduction (MBSR) and Mindfulness-Based Cognitive Therapy (MBCT), is widely used to treat various conditions such as stress, depression, and chronic pain, but concerns about its safety have emerged due to reported adverse events.

The viewpoint argues that many reported negative experiences during mindfulness meditation, such as anxiety or discomfort, are not true adverse events but rather expected reactions that can occur as individuals learn to manage their mental and physical states; severe outcomes like psychosis are often influenced by external factors rather than the meditation itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

What Are Adverse Events in Mindfulness Meditation? Binda, DD., Greco, CM., Morone, NE.[2022]

A study using the mindfulness app Headspace found that 4 weeks of access significantly reduced anxiety symptoms in participants with moderate to high anxiety, and this effect was maintained at 8 weeks, indicating the app's effectiveness.

While the app also showed potential in reducing worry, the analysis did not find a significant difference in worry reduction between 4 and 8 weeks of access, suggesting that longer use may not necessarily lead to greater benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does Using a Mindfulness App Reduce Anxiety and Worry? A Randomized-Controlled Trial. Abbott, D., Lack, CW., Anderson, P.[2023]

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