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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)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 8 weeks
Awards & highlights

Study Summary

This trial will identify a way to help manage anxiety in older adults with serious illness and their caregivers.

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.Check my eligibility
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.See study design
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.

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

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

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

Find a Location

Who is running the clinical trial?

Rutgers, The State University of New JerseyLead Sponsor
429 Previous Clinical Trials
64,070 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any vacancies available for patients to join this clinical trial?

"According to the clinicaltrials.gov registry, this medical trial is still accepting participants. It was initially announced on April 26th 2022 and has recently been refreshed as of June 27th 2022."

Answered by AI

How many participants are taking part in this research?

"That is correct. Data hosted on clinicaltrials.gov affirms that this medical experiment, which was initially published on April 26th 2022, is actively recruiting volunteers. 162 people are sought to join the trial from 3 separate sites."

Answered by AI

What objectives is this experiment attempting to accomplish?

"This trial's primary measure of success is the Hospital Anxiety and Depression Scale - Anxiety Subscale, which will be monitored for about two months. Other metrics that are being tracked include HADS-D (depression), Perceived Stress Scale (0-40 with higher numbers indicating more stress) and Hospital Anxiety and DepressionScale - Depression Subscale (range 0-21; high scores signify greater depression)."

Answered by AI

Who else is applying?

What state do they live in?
New York
New Jersey
Maryland
How old are they?
18 - 65
What site did they apply to?
RWJ Barnabas Outpatient Geriatric Clinics
RWJB Outpatient Geriatrics
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
3+

How responsive is this trial?

Typically responds via
Phone Call
Email
Recent research and studies
clinicaltrials.govStudy
mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
Elissa Kozlov, Ph.D 2022. "mHealth Mindfulness With Patients With Serious Illness and Their Caregivers". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05040711.
~67 spots leftby Oct 2025
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