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NCT Number: NCT05040711

mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

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.

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Key information

Conditions

Caregiver Stress Syndrome Anxiety Anxiety Disorders Mental Disorders

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

RWJ Barnabas Outpatient Geriatric Clinics, Livingston, New Jersey, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness Coach

Behavioral

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

Behavioral

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.

Other names: WebMD

Primary outcomes

  1. Hospital Anxiety and Depression Scale - Anxiety Sub Scale

    Time frame: 6 months

    Anxiety scale with range from 0-21 with higher scores denoting highest anxiety

  2. Hospital Anxiety and Depression Scale - Anxiety Sub Scale

    Time frame: 8 weeks

    Anxiety scale with range from 0-21 with higher scores denoting highest anxiety

Secondary outcomes

  1. Hospital Anxiety and Depression Scale - Depression Sub Scale

    Time frame: 6 months

    Depression scale with range from 0-21 with higher scores denoting highest depression

  2. Hospital Anxiety and Depression Scale - Depression Sub Scale

    Time frame: 8 weeks

    Depression scale with range from 0-21 with higher scores denoting highest depression

  3. Perceived stress scale

    Time frame: 8 weeks

    Scale with range from 0 - 40 with higher values indicating more perceived stress

Study contacts

Contact information is provided by the study sponsor or research team.

Danielle Llaneza, MA

CONTACT

[email protected]

ELISSA KOZLOV, PhD

CONTACT

[email protected]

9147153012

Sponsors and collaborators

Lead sponsor

Rutgers, The State University of New Jersey

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2026
First posted
Sep 10, 2021
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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