mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

Not Applicable

Recruiting

• Conditions: Caregiver Stress Syndrome; Anxiety

• Registration Number: NCT05040711
• Lead Sponsor: Rutgers, The State University of New Jersey

Brief 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.

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.

Study Timeline

• Study First Submitted: 2021-09-07
• Study First Submitted QC: 2021-09-07
• Study First Posted: 2021-09-10
• Study Start: 2022-04-26
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-09
• Last Update Posted: 2024-04-10
• Primary Completion: 2025-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 162

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale - Anxiety Sub Scale	8 weeks	Anxiety scale with range from 0-21 with higher scores denoting highest anxiety

Secondary Outcome Measures

Name	Time	Method
Hospital Anxiety and Depression Scale - Depression Sub Scale	8 weeks	Depression scale with range from 0-21 with higher scores denoting highest depression
Perceived stress scale	8 weeks	Scale with range from 0 - 40 with higher values indicating more perceived stress

Trial Locations

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