mHealth Mindfulness With Patients With Serious Illness and Their Caregivers
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21+
SponsorRutgers, The State University of New Jersey
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Mindfulness Coach
BehavioralThis 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
BehavioralA 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.
Treatment groups
162 Participants
are divided into 2 treatment groupsGroup A: mindfulness coachExperimental treatment 1 intervention
Group B: control - web MDActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Hospital Anxiety and Depression Scale - Anxiety Sub Scale
Anxiety scale with range from 0-21 with higher scores denoting highest anxiety
Time frame
6 months2
Hospital Anxiety and Depression Scale - Anxiety Sub Scale
Anxiety scale with range from 0-21 with higher scores denoting highest anxiety
Time frame
8 weeksSecondary outcomes
1
Hospital Anxiety and Depression Scale - Depression Sub Scale
Depression scale with range from 0-21 with higher scores denoting highest depression
Time frame
6 months2
Hospital Anxiety and Depression Scale - Depression Sub Scale
Depression scale with range from 0-21 with higher scores denoting highest depression
Time frame
8 weeks3
Perceived stress scale
Scale with range from 0 - 40 with higher values indicating more perceived stress
Time frame
8 weeksSponsors and contacts
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Source ClinicalTrials.gov