Recruiting

Anxiety Management

Sponsor:

Rutgers, The State University of New Jersey

Code:

NCT05040711

Conditions

Caregiver Stress Syndrome

Anxiety

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

Interventions

Mindfulness Coach

Active Comparator

Study Details

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

Study ID

NCT05040711

Start date

Apr 26, 2022

Status verified date

Apr, 2026

Completion date

Oct 1, 2026

Anticipated

Primary completion date

Oct 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 21+

Healthy Volunteers: Accepted

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

Enrollment

162 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: mindfulness coach

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.

active comparator: control - web MD

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.

Interventions

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.

Primary outcome measure

  • Hospital Anxiety and Depression Scale - Anxiety Sub Scale [ Time Frame: 6 months ]
  • Hospital Anxiety and Depression Scale - Anxiety Sub Scale [ Time Frame: 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

RWJ Barnabas Outpatient Geriatric Clinics

Recruiting

Livingston, New Jersey, United States, 07039

RWJB Outpatient Geriatrics

Recruiting

Monroe, New Jersey, United States, 08831

Cancer Institute of New Jersey

Recruiting

New Brunswick, New Jersey, United States, 08901

More Information

Sponsor

Rutgers, The State University of New Jersey

Last update posted

Apr 24, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Rutgers, The State University of New Jersey on 2026-04-24.