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Behavioral Intervention

Mobile Health Mindfulness for Anxiety

N/A
Recruiting
Led By Elissa Kozlov, PhD
Research Sponsored by Rutgers, The State University of New Jersey
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 60+
Diagnosis of or caregiver for individual with serious illnesses (e.g., ESRD, Cancer, CHF, COPD, Liver Disease)
Must not have
Not fluent in English
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial tests a mobile app called Mindfulness Coach to help older adults with serious illness and their caregivers reduce anxiety. The app provides mindfulness exercises that help users focus on the present moment, making them feel less anxious. This approach aims to offer an effective, non-drug treatment for anxiety in this group. Mindfulness Coach is a mobile app designed to deliver mindfulness training and has been used in various studies to assess its impact on mental health.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial involves non-pharmacological treatment through mindfulness coaching, there may not be direct side effects as seen with medication. However, participants might experience emotional discomfort when confronting anxious feelings during sessions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 60 years old or older.
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I have or care for someone with a serious illness like cancer or liver disease.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not fluent in English.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~8 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 8 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Hospital Anxiety and Depression Scale - Anxiety Sub Scale
Secondary study objectives
Hospital Anxiety and Depression Scale - Depression Sub Scale
Perceived stress scale

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: mindfulness coachExperimental Treatment1 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 MDActive Control1 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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mindfulness Coach
2019
N/A
~370

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for anxiety, such as Cognitive Behavioral Therapy (CBT), Mindfulness-Based Cognitive Therapy (MBCT), and Interpersonal Psychotherapy (IPT), work through different mechanisms to reduce symptoms. CBT focuses on identifying and challenging negative thought patterns and behaviors. MBCT combines mindfulness practices with cognitive therapy to help patients accept their thoughts and feelings without judgment. IPT aims to improve interpersonal relationships and social functioning. Understanding these mechanisms helps patients and healthcare providers select the most suitable treatment based on individual needs and triggers.
The Effect of Melatonin Upon Postacute Withdrawal Among Males in a Residential Treatment Program (M-PAWS): A Randomized, Double-blind, Placebo-controlled Trial.

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
455 Previous Clinical Trials
69,789 Total Patients Enrolled
7 Trials studying Anxiety
1,407 Patients Enrolled for Anxiety
Elissa Kozlov, PhDPrincipal InvestigatorRutgers University

Media Library

Mindfulness Coach (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05040711 — N/A
Anxiety Research Study Groups: control - web MD, mindfulness coach
Anxiety Clinical Trial 2023: Mindfulness Coach Highlights & Side Effects. Trial Name: NCT05040711 — N/A
Mindfulness Coach (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05040711 — N/A
~36 spots leftby Oct 2025