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

Anxiety Caregiver Stress Syndrome

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

Inclusion Criteria11

adults 60+
Diagnosis of or caregiver for individual with serious illnesses (e.g., ESRD, Cancer, CHF, COPD, Liver Disease)
Hads-A \> 8 for patient or caregiver
Blessed\<6
fluent in English
vision and hearing does not interfere with mobile device use
caregivers who must be 21+
caregiver must identify as primary source of informal care for patient
Caregiver blessed \<6
caregiver is fluent in English
Caregiver's vision and hearing does not interfere with mobile device use.

Exclusion Criteria4

experience with mindfulness therapy in last 2 years
not fluent in English
vision or hearing that impairs use of mobile device
cognitive impairment more than 6 on Blessed.

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.