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RECRUITING
NCT05040711
NA

mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

Sponsor: Rutgers, The State University of New Jersey

View on ClinicalTrials.gov

Summary

Older adults with serious illness and their caregivers have high rates of anxiety and limited access to effective, non-pharmacological treatments. A recent National Academy of Medicine report recommended increased emphasis on disseminating and implementing evidence-based psychotherapies in order to have maximal public health impact. Through this work, I will identify a sustainable and potentially scalable dyadic intervention and delivery model to manage symptoms of anxiety in older adults with serious illness and their caregivers in primary care.

Official title: Piloting an mHealth-delivered Mindfulness Therapy With Patients With Serious Illness and Their Caregivers to Alleviate Symptoms of Anxiety

Key Details

Gender

All

Age Range

21 Years - Any

Study Type

INTERVENTIONAL

Enrollment

162

Start Date

2022-04-26

Completion Date

2026-10-01

Last Updated

2024-04-10

Healthy Volunteers

Yes

Interventions

BEHAVIORAL

Mindfulness Coach

This study will use Mindfulness Coach, 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. The app 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. 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.

BEHAVIORAL

Active Comparator

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.

Locations (3)

RWJ Barnabas Outpatient Geriatric Clinics

Livingston, New Jersey, United States

RWJB Outpatient Geriatrics

Monroe, New Jersey, United States

Cancer Institute of New Jersey

New Brunswick, New Jersey, United States