RecruitingNot ApplicableNCT05040711

mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

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


Sponsor

Rutgers, The State University of New Jersey

Enrollment

162 participants

Start Date

Apr 26, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 21 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a mindfulness app delivered on a smartphone can help reduce anxiety in older adults (60+) with serious illnesses like cancer, heart failure, kidney disease, COPD, or liver disease — and in their family caregivers. **You may be eligible if...** - You are 60 or older with a serious illness such as end-stage kidney disease, cancer, heart failure, COPD, or liver disease — or you are a primary caregiver for someone with such a condition - You score above 8 on the anxiety screening questionnaire (HADS-A) - You can use a mobile device without major difficulty due to vision or hearing - You are fluent in English - Caregivers must be 21 or older **You may NOT be eligible if...** - You have practiced mindfulness therapy in the past 2 years - You have significant cognitive impairment (Blessed score above 6) - Your vision or hearing prevents effective mobile device use - You are not fluent in English Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALMindfulness 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.

BEHAVIORALActive 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

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NCT05040711


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