Clinical trial NCT05040711: mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
Official title: Piloting an mHealth-delivered Mindfulness Therapy With Patients With Serious Illness and Their Caregivers to Alleviate Symptoms of Anxiety
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Caregiver Stress Syndrome
Anxiety
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2021-09-10
Enrollment: 162
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Hospital Anxiety and Depression Scale - Anxiety Sub Scale
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale - Anxiety Sub Scale
timeFrame: 8 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale - Depression Sub Scale
timeFrame: 6 months
measure: Hospital Anxiety and Depression Scale - Depression Sub Scale
timeFrame: 8 weeks
measure: Perceived stress scale
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Livingston
country: United States
facility: RWJ Barnabas Outpatient Geriatric Clinics
state: New Jersey
city: Monroe
country: United States
facility: RWJB Outpatient Geriatrics
state: New Jersey
city: New Brunswick
country: United States
facility: Cancer Institute of New Jersey
state: New Jersey
Study officials:
affiliation: Rutgers University
name: Elissa Kozlov, PhD
role: PRINCIPAL_INVESTIGATOR
References: