Mindfulness Intervention for Stress and Anxiety

(MIND-CARE Trial)

Overseen By Kahsi A Pedersen, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: MaineHealth

Disqualifiers: Deafness, blindness, impaired decision making, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mindfulness app to determine if it reduces stress and anxiety for caregivers of children with autism in rural Maine. Participants will engage in a 30-day mindfulness program using the app, which they can complete over 60 days. The goal is to assess whether this app can alleviate stress and anxiety in caregivers. Ideal participants live in rural Maine, care for a child with autism, reside with a partner who can also join the study, and have a smartphone with internet access. As an unphased trial, this study provides caregivers an opportunity to explore innovative stress-reduction techniques tailored to their unique needs.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on a mindfulness program, so it's likely you can continue your medications, but you should confirm with the trial organizers.

What prior data suggests that this mindfulness intervention is safe?

Research shows that mindfulness apps are generally safe to use. Studies have found that people usually handle these programs well, with no major safety issues reported. For instance, one study on a similar app found that users did not experience significant negative effects. Many reported feeling less stressed.

However, the effects of these apps can vary. Some research shows mixed results, with only small improvements in stress levels for some users. Despite this, using a mindfulness app is usually considered low-risk. This makes it a promising option for managing stress and anxiety in daily life. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the app-based mindfulness intervention for stress and anxiety because it offers a unique, accessible way to manage these conditions. Unlike traditional therapies that often involve in-person sessions with a therapist or medication, this treatment is delivered through a mobile app, allowing users to access mindfulness exercises anytime and anywhere. This approach not only reduces barriers to access, like time and cost, but also empowers individuals to integrate stress-reducing practices into their daily lives more seamlessly. Additionally, the app's interactive and user-friendly design can cater to a wider audience, potentially reaching those who might not otherwise seek help.

What evidence suggests that this app-based mindfulness intervention is effective for reducing stress and anxiety in caregivers of children with ASD?

Research has shown that mindfulness activities can help reduce stress and anxiety. One study found that using a mindfulness app for six weeks significantly lowered anxiety symptoms. Another study demonstrated that these apps can improve mental health by reducing stress. However, results can vary, and some studies have reported mixed findings on stress reduction. Overall, mindfulness apps seem promising for helping people manage stress and anxiety, making them a useful option for caregivers facing these challenges. Participants in this trial will receive an app-based mindfulness intervention to further explore its effectiveness in reducing stress and anxiety. ^{1 2 3 5 6}

Who Is on the Research Team?

Kahsi A Pedersen, PhD

Principal Investigator

MaineHealth

Are You a Good Fit for This Trial?

This trial is for adult caregivers living with and caring for a child with Autism Spectrum Disorder in rural Maine. They must speak English, be over 18, live with their romantic partner who will also join the study, and not be guardians under DHHS.

Inclusion Criteria

The caregiver must live in a rural area in Maine, based on certain codes.

The person taking care of you must be legally allowed to make decisions for you, and cannot be a guardian or foster parent under the Department of Health and Human Services.

The caregiver must confirm that their child has been diagnosed with autism spectrum disorder (ASD) by a doctor.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Mindfulness Training

Participants engage in a 30-day mindfulness program that can be completed over a maximum of 60 days, practicing daily mindfulness lessons and responding to questions about anxiety levels.

4-8 weeks

Daily virtual engagement

Follow-up

Participants are monitored for changes in stress and anxiety levels, with data collection at baseline, midpoint, endpoint, and 1-year follow-up.

1 year

What Are the Treatments Tested in This Trial?

Interventions

• App-based Mindfulness Intervention

Trial Overview The trial tests an app-based mindfulness program designed to reduce stress and anxiety among these caregivers. Over up to 60 days, participants will follow daily mindfulness lessons and report on their anxiety levels.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

All study participants will receive the app-based mindfulness intervention.

Who Is Running the Clinical Trial?

MaineHealth

Lead Sponsor

Trials

76

Recruited

43,800+

Published Research Related to This Trial

Mindfulness-Based Stress Reduction (MBSR) has been shown to improve mental health in 11 studies compared to waitlist controls or treatment as usual, demonstrating its efficacy as a therapeutic intervention.

Mindfulness-Based Cognitive Therapy (MBCT) effectively reduces the risk of depressive relapse, showing similar efficacy to treatment as usual in two studies, indicating its potential as a preventive measure for depression.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. Fjorback, LO., Arendt, M., Ornbøl, E., et al.[2022]

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 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]

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]

The article reviews the Calm app, which focuses on mindfulness meditation, highlighting its potential benefits for clinical practice.

Mindfulness meditation apps like Calm may offer accessible tools for mental health support, although specific efficacy data or study details are not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Calm: A review of the mindful meditation app for use in clinical practice. May, AD., Maurin, E.[2021]

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]

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 systematic review of ten studies on technology-based mindfulness interventions found significant clinical effects on stress, depression, and anxiety, with large effect sizes reported for stress (d = 1.57) and depression (d = 0.95).

Despite promising results, the studies had methodological limitations such as selection bias and lack of control groups, indicating that further research is needed to refine these interventions and establish their effectiveness more reliably.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? Fish, J., Brimson, J., Lynch, S.[2022]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10439468/

Mindfulness-Based Mobile Apps and Their Impact on Well ... The efficacy of a brief app-based mindfulness intervention on psychosocial outcomes in healthy adults: a pilot randomised controlled trial.

2. sciencedirect.com sciencedirect.com/science/article/pii/S0272735824001363

Efficacy of app-based mobile health interventions for stress ... The average duration of intervention was 5 weeks, with an average session duration of 14.61 min. The average dropout rate was 22.18 % at post, and 22.56 % at ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12010245/

App-based mindfulness meditation reduces stress in novice ... App-based mindfulness meditation programs have shown mixed effects in reducing stress levels. These studies have typically relied on limited ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2822451

Efficacy of a Mobile App-Based Intervention for Young ... However, after 6 weeks of use of the app, there was a clinically and statistically significant decrease in anxiety symptoms across conditions.

5. nature.com nature.com/articles/s44184-023-00048-5

The impact of mindfulness apps on psychological ... Mindfulness-based interventions (MBIs) have demonstrated efficacy in improving a range of clinical outcomes, such as depression and anxiety. In ...

6. mhealth.jmir.org mhealth.jmir.org/2024/1/e52968

The Real-World Impact of App-Based Mindfulness on ... These data indicate that consistent Headspace use results in more prominent improvements in perceived stress. Previous research has reported ...