NCT04150055

Brief Summary

The investigators will recruit 60 family caregivers of older adults with cognitive impairment or dementia to participate in a pilot feasibility and acceptability trial of Mindfulness Coach, an mHealth mobile application that delivers mindfulness therapy. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The app also offers a library of information about MT (e.g., "how to anchor participants' attention"), 12 audio-guided mindfulness exercises, and a catalog of additional exercises available for free. In addition to collecting data about the feasibility and acceptability of Mindfulness Coach with caregivers of patients with dementia or cognitive impairment, the investigators will also collect data on preliminary efficacy of Mindfulness Coach at relieving symptoms of caregiver burden, anxiety, stress and depression.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 4, 2019

Completed
1 day until next milestone

Study Start

First participant enrolled

November 5, 2019

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 8, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 8, 2021

Completed
Last Updated

September 5, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

October 30, 2019

Last Update Submit

September 3, 2021

Conditions

Caregiver BurnoutStressAnxiety

Keywords

mindfulnesscaregiverpalliative care

Outcome Measures

Primary Outcomes (3)

  • Feasibility - amount of time participants spend in app

    how much do caregivers use mindfulness coach

    8 weeks

  • Acceptability - satisfaction with mindfulness coach survey

    Do caregivers find mindfulness coach helpful and easy to use?

    8 weeks

  • Bakas Caregiver Outcomes Scale - 15 items

    scores range from 15-105 with higher scores indicating better outcomes

    8 weeks

Secondary Outcomes (4)

  • hospital anxiety and depression scale- anxiety sub scale

    8 weeks

  • hospital anxiety and depression scale, depression sub scale

    8 weeks

  • The World Health Organization Quality of Life Brief

    8 weeks

  • perceived stress scale

    8 weeks

Study Arms (1)

Intervention

EXPERIMENTAL

Everyone in the study will get Mindfulness Coach and an orientation session. Mindfulness Coach is a self-guided mHealth intervention designed to help individuals learn MT, an evidence-based treatment to enhance health, wellness and mental health. The intervention will be introduced during 1 in-person session by a trained research assistant with 1-2 booster instructional phone call at 7 and 14-days to ensure that the participant knows how and is encouraged to use the app. The participant will also be provided with a laminated card that provides the basic instructions. We will encourage the participant to use Mindfulness Coach weekly for 8 weeks, or more if desired, as this treatment dose is commensurate with most in-person MT psychotherapy treatment protocols.

Behavioral: Mindfulness Coach

Interventions

Mindfulness CoachBEHAVIORAL

Mindfulness Coach is an mHealth delivered mindfulness therapy.

Intervention

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • owns a smart phone or tablet
  • speaks English fluently, aged 21+
  • identifies as the caregiver for an older adult with dementia or mild cognitive impairment

You may not qualify if:

  • does not own smart phone or tablet
  • does not speak English fluently
  • is under age 21
  • does not provide care for older adult with dementia or mild cognitive impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

RWJ Barnabas Monmouth South

Lakewood, New Jersey, 08701, United States

Location

RWJ Barnabas

Monroe, New Jersey, 08331, United States

Location

MeSH Terms

Conditions

Caregiver BurdenAnxiety Disorders

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Core Faculty, Instructor

Study Record Dates

First Submitted

October 30, 2019

First Posted

November 4, 2019

Study Start

November 5, 2019

Primary Completion

March 8, 2021

Study Completion

March 8, 2021

Last Updated

September 5, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)