mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Mindfulness Coach, Active Comparator.
- Who it may be relevant to
- Registry conditions: Caregiver Stress Syndrome, Anxiety. Basic parameters: from 21 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Piloting an mHealth-delivered Mindfulness Therapy With Patients With Serious Illness and Their Caregivers to Alleviate Symptoms of Anxiety
Overview
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.
Detailed description
Research: Up to 70% of adults with serious illness have symptoms of anxiety. Undiagnosed and undertreated anxiety contributes to higher risk of pain, depression, fatigue, dyspnea, and polypharmacy. Patients with high symptom burden and anxiety heavily impact family caregivers, which nearly 8 million older adults in the U.S. rely on for assistance. Decades of research reveal the negative effects of caregiving on caregivers, (e.g., high levels of stress, depression, and anxiety). Furthermore, there is a mutuality of distress in the caregiver/patient dyad - when patients suffer psychologically, the caregiver suffers too. Unfortunately, older adults and their caregivers have limited access to mental health resources because of shortages of mental health providers as well as logistical issues including time constraints, transportation, and scheduling. The objective of this study is to evaluate the feasibility, acceptability, and preliminary efficacy of Mindfulness Coach, an mHealth Mindfulness Therapy intervention developed by the Veterans Affairs, to reduce anxiety in older adults with serious illness and their family caregivers. An efficacious and scalable behavioral intervention that mitigates symptoms of patient and caregiver anxiety has the potential to reduce distress and enhance coping in the patient-caregiver dyad without contributing to polypharmacy or burdensome appointments. Research is urgently needed to evaluate the feasibility, acceptability, and preliminary efficacy of dyadic mHealth mindfulness therapy in older adults with serious illness and their caregivers.
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 Mindful - 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
Primary outcome measures
- Hospital Anxiety and Depression Scale - Anxiety Sub Scale [Time frame: 6 months]
- Hospital Anxiety and Depression Scale - Anxiety Sub Scale [Time frame: 8 weeks]
Secondary outcome measures (3)
- Hospital Anxiety and Depression Scale - Depression Sub Scale [Time frame: 6 months]
- Hospital Anxiety and Depression Scale - Depression Sub Scale [Time frame: 8 weeks]
- Perceived stress scale [Time frame: 8 weeks]
Eligibility criteria
Inclusion criteria
- 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 criteria
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- RWJ Barnabas Outpatient Geriatric Clinics — Livingston
- RWJB Outpatient Geriatrics — Monroe
- Cancer Institute of New Jersey — New Brunswick
Identifiers
NCT: NCT05040711 · Pro2021001219