mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

Anxiety Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05040711
• Other study ID #: Pro2021001219
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2022
• Est. completion date: October 1, 2026

Study information

• Verified date: April 2024
• Source: Rutgers, The State University of New Jersey
• Contact: ELISSA KOZLOV, PhD
• Phone: 9147153012
• Email: elissa.kozlov[@]Rutgers.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 162
• Est. completion date: October 1, 2026
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Caregiver Stress Syndrome

Intervention

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.
• 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

Country	Name	City	State
United States	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

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospital Anxiety and Depression Scale - Anxiety Sub Scale	Anxiety scale with range from 0-21 with higher scores denoting highest anxiety	6 months
Primary	Hospital Anxiety and Depression Scale - Anxiety Sub Scale	Anxiety scale with range from 0-21 with higher scores denoting highest anxiety	8 weeks
Secondary	Hospital Anxiety and Depression Scale - Depression Sub Scale	Depression scale with range from 0-21 with higher scores denoting highest depression	6 months
Secondary	Hospital Anxiety and Depression Scale - Depression Sub Scale	Depression scale with range from 0-21 with higher scores denoting highest depression	8 weeks
Secondary	Perceived stress scale	Scale with range from 0 - 40 with higher values indicating more perceived stress	8 weeks