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Clinical Trials/NCT04378803
NCT04378803
Completed
N/A

Mindfulness Training for Older Adults During the COVID-19 Pandemic

University of Miami1 site in 1 country53 target enrollmentMay 13, 2020
ConditionsWell Aging

Overview

Phase
N/A
Intervention
Not specified
Conditions
Well Aging
Sponsor
University of Miami
Enrollment
53
Locations
1
Primary Endpoint
Change in mindfulness skills as measured by Five-Facet Mindfulness Questionnaire (5FMQ)
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

The purpose of this research study is to learn more about how mindfulness training may influence thinking and feeling.

Registry
clinicaltrials.gov
Start Date
May 13, 2020
End Date
August 4, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ekaterina Denkova

Research Assistant Professor

University of Miami

Eligibility Criteria

Inclusion Criteria

  • Individuals who are between 60 and 95 years of age
  • Individuals who are fluent English speakers
  • Individuals who are able to adequately and independently use electronic devices, such as a laptop, computer, or tablet, and have an Internet connection
  • Individuals who are willing and able to consent to participate in the study

Exclusion Criteria

  • Individuals who are cognitively impaired and not independent in daily activities, such as the use of the telephone, preparing meals
  • Individuals with an active and untreated mental condition (e.g., Bipolar disorder, Major Depression) and/or hospitalization for psychological/mental health issues within the last month.

Outcomes

Primary Outcomes

Change in mindfulness skills as measured by Five-Facet Mindfulness Questionnaire (5FMQ)

Time Frame: Baseline to week 10

5FMQ is a 15-item questionnaire with 5 sub-scales: observing, describing, acting with awareness, non-judgmental inner experience, and non-reactivity. The score for each sub-scale ranges from 3 to 15, a higher score is indicative of greater mindfulness skills.

Change in mindfulness skills as measured by decentering - Experiences Questionnaire (EQ).

Time Frame: Baseline to week 10

EQ Decentering is an 11-item sub-scale measuring various thoughts and experiences, and the tendency to distance from those. The decentering score ranges from 1 to 55, with a higher score indicating high level of decentering.

Change in psychological health as measured by Patient Health Questionnaire 4 items (PHQ4).

Time Frame: Baseline to week 10

PHQ4 is an ultra-brief 4-item measure of depression and anxiety with the total score ranging from 0 to 12. Higher score indicates higher level of anxiety and depression.

Change in positive affect on psychological health as measured by the short variant of the Positive and Negative Affect Scale (PANAS).

Time Frame: Baseline to week 10

The PANAS positive sub-scale includes 5 items with a score ranges from 5 to 25 with a higher score indicating a higher positive mood.

Change in negative affect on psychological health as measured by the short variant of the Positive and Negative Affect Scale (PANAS).

Time Frame: Baseline to week 10

The PANAS negative sub-scale includes 5 items with a score ranges from 5 to 25 with a higher score indicating a higher negative mood.

Change in loneliness measured by the loneliness questions from the social isolation battery.

Time Frame: Baseline to week 10

The 3 loneliness questions from the social isolation battery will be used to measure loneliness with each question has a score ranging from 1 to 3 and a higher score indicates more loneliness.

Change in loneliness measured by a loneliness question.

Time Frame: Baseline to week 10

The loneliness question will be used to measure perceived loneliness with a score ranging from 1 to 7 and a higher score indicates more loneliness.

Secondary Outcomes

  • Change in well-being as measured by the Experience of Intrusions Scale (EIS)(Baseline to week 10)
  • Change in attention(Baseline to week 10)
  • Change in well-being as measured by the Perseverative Thought Questionnaire (PTQ)(Baseline to week 10)
  • Change in well-being as measured by the short version of the perceived stress scale (PSS).(Baseline to week 10)
  • Change in well-being as measured by the PERMA-Profiler(Baseline to week 10)

Study Sites (1)

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