40 Participants Needed

Mindfulness Intervention for Stress and Anxiety

(MIND-CARE Trial)

KA
Overseen ByKahsi A Pedersen, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: MaineHealth
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

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 data supports the effectiveness of the treatment App-based Mindfulness Intervention for stress and anxiety?

Research shows that app-based mindfulness interventions can significantly reduce anxiety and stress. Studies found that using mindfulness apps like Headspace and VGZ Mindfulness Coach led to decreased anxiety symptoms and improved mindfulness, quality of life, and general psychiatric symptoms.12345

Is mindfulness intervention safe for humans?

Mindfulness interventions, including app-based ones, are generally considered safe, but some people may experience negative effects like increased distress or dependency on the app. It's important to be aware of these potential risks and monitor your own experience.25678

How does the app-based mindfulness treatment differ from other treatments for stress and anxiety?

The app-based mindfulness treatment is unique because it offers mindfulness training through a smartphone app, making it more accessible and scalable compared to traditional in-person programs. It focuses on reducing anxiety and worry by addressing these issues as habits, and it has shown effectiveness in improving mental health with small-to-moderate benefits.2491011

What is the purpose of this trial?

The purpose of this clinical trial is to investigate the effectiveness of a mobile app-based mindfulness program in improving the mental well-being of caregivers with a child diagnosed with autism spectrum disorder (ASD) who live in rural areas of Maine. The primary question the investigators aim to answer is whether this mindfulness intervention can reduce stress and anxiety in these rural caregivers of children with ASD. Participants in the trial will engage in a 30-day mindfulness program that they can complete over a maximum of 60 days. During this time, they will practice short daily mindfulness lessons and respond to a set of brief questions regarding their anxiety levels. Ultimately, the investigators want to assess whether this intervention helps these caregivers feel less stressed and anxious.

Research Team

KA

Kahsi A Pedersen, PhD

Principal Investigator

MaineHealth

Eligibility Criteria

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.
See 6 more

Timeline

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

Treatment Details

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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: InterventionExperimental Treatment1 Intervention
All study participants will receive the app-based mindfulness intervention.

Find a Clinic Near You

Who Is Running the Clinical Trial?

MaineHealth

Lead Sponsor

Trials
76
Recruited
43,800+

Findings from Research

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.
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 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.
Does Using a Mindfulness App Reduce Anxiety and Worry? A Randomized-Controlled Trial.Abbott, D., Lack, CW., Anderson, P.[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.
Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial.van Emmerik, AAP., Berings, F., Lancee, J.[2020]

References

Mindfulness Interventions Delivered by Technology Without Facilitator Involvement: What Research Exists and What Are the Clinical Outcomes? [2022]
Does Using a Mindfulness App Reduce Anxiety and Worry? A Randomized-Controlled Trial. [2023]
Efficacy of a Mindfulness-Based Mobile Application: a Randomized Waiting-List Controlled Trial. [2020]
Calm: A review of the mindful meditation app for use in clinical practice. [2021]
Mindfulness-based stress reduction and mindfulness-based cognitive therapy: a systematic review of randomized controlled trials. [2022]
Practicing Mindfulness through mHealth Applications: Emerging Adults' Health-Enhancing and Inhibiting Experiences. [2023]
Adverse or therapeutic? A mixed-methods study investigating adverse effects of Mindfulness-Based Cognitive Therapy in bipolar disorder. [2021]
First, do no harm: An intensive experience sampling study of adverse effects to mindfulness training. [2021]
Can Approaching Anxiety Like a Habit Lead to Novel Treatments? [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The effects of app-based mindfulness practice on the well-being of university students and staff. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Improvements in Stress, Affect, and Irritability Following Brief Use of a Mindfulness-based Smartphone App: A Randomized Controlled Trial. [2023]
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