mHealth Mindfulness With Patients With Serious Illness and Their Caregivers

NCT05040711 | Recruiting

• 1 other identifier: Pro2021001219
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 3

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.

Conditions

Caregiver Stress Syndrome; Anxiety

Outcome Measures

Primary Outcomes (2)

• Hospital Anxiety and Depression Scale - Anxiety Sub Scale

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

  6 months

• Hospital Anxiety and Depression Scale - Anxiety Sub Scale

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

  8 weeks

Secondary Outcomes (3)

• Hospital Anxiety and Depression Scale - Depression Sub Scale

  6 months

• Hospital Anxiety and Depression Scale - Depression Sub Scale

  8 weeks

• Perceived stress scale

  8 weeks

Study Arms (2)

mindfulness coach

EXPERIMENTAL

Mindfulness coach is an app that 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 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. . 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.

Behavioral: Mindfulness Coach

control - web MD

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.

Behavioral: Active Comparator

Interventions

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.

mindfulness coach

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.

Also known as: WebMD

control - web MD

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead

Study Sites (3)

RWJ Barnabas Outpatient Geriatric Clinics

Livingston, New Jersey, 07039, United States

RECRUITING

RWJB Outpatient Geriatrics

Monroe, New Jersey, 08831, United States

RECRUITING

Cancer Institute of New Jersey

New Brunswick, New Jersey, 08901, United States

RECRUITING

MeSH Terms

Conditions

Anxiety Disorders

Condition Hierarchy (Ancestors)

Mental Disorders

Study Officials

• Elissa Kozlov, PhD

  Rutgers University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

ELISSA KOZLOV, PhD

CONTACT

9147153012; elissa.kozlov@Rutgers.edu

Danielle Llaneza, MA

CONTACT

dhl2132@tc.columbia.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor

Study Record Dates

• First Submitted: September 7, 2021
• First Posted: September 10, 2021
• Study Start: April 26, 2022
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (3)