Mindfulness Training for Seniors

Mindfulness Training for Older Adults During the COVID-19 Pandemic

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

Study Overview

• Status: Completed
• Conditions: Well Aging
• Intervention / Treatment: Behavioral: Mindfulness training (MT) Connect

• Study Type: Interventional
• Enrollment (Actual): 53
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Florida
    • Coral Gables, Florida, United States, 33146
      • University of Miami

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 95 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mindfulness training (MT) group; Receives 4 weeks of mindfulness training followed by a testing session. Then, 4 weeks of no-training interval followed by a testing session.	Behavioral: Mindfulness training (MT) Connect; MT Connect will involve instructor-led weekly sessions and mindfulness exercises over a 4-week interval for a total of 8 to 10 hours. There will be one instructor-led session per week that will last between 2 and 2.5 hours. Participants will also be asked to complete three categories of mindfulness exercises (formal and informal mindfulness exercises, and reflective practices) as part of their daily 'out-of-class' homework. The daily homework will require between 10 to 30 minutes to complete.
Experimental: Wait-list control (WLC) group; Receives 4 weeks of no-training interval followed by a testing session. Then, 4 weeks of mindfulness training followed by a testing session.	Behavioral: Mindfulness training (MT) Connect; MT Connect will involve instructor-led weekly sessions and mindfulness exercises over a 4-week interval for a total of 8 to 10 hours. There will be one instructor-led session per week that will last between 2 and 2.5 hours. Participants will also be asked to complete three categories of mindfulness exercises (formal and informal mindfulness exercises, and reflective practices) as part of their daily 'out-of-class' homework. The daily homework will require between 10 to 30 minutes to complete.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in mindfulness skills as measured by Five-Facet Mindfulness Questionnaire (5FMQ)	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.	Baseline to week 10
Change in mindfulness skills as measured by decentering - Experiences Questionnaire (EQ).	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.	Baseline to week 10
Change in psychological health as measured by Patient Health Questionnaire 4 items (PHQ4).	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.	Baseline to week 10
Change in positive affect on psychological health as measured by the short variant of the Positive and Negative Affect Scale (PANAS).	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.	Baseline to week 10
Change in negative affect on psychological health as measured by the short variant of the Positive and Negative Affect Scale (PANAS).	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.	Baseline to week 10
Change in loneliness measured by the loneliness questions from the social isolation battery.	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.	Baseline to week 10
Change in loneliness measured by a loneliness question.	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.	Baseline to week 10

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in attention	Attention is measured by using the Sustained Attention Response Task that involves pressing a button to frequently presented non-target trials (numbers 1, 2, 4, 5, 6, 7, 8, and 9) and withholding the button press to the infrequent target trials (number 3). The score (A prime) is calculated by considering accuracy on both non-target and target trials with a score maximum of 1. A higher score indicates better attentional performance.	Baseline to week 10
Change in well-being as measured by the Perseverative Thought Questionnaire (PTQ)	PTQ is a 15-item questionnaire indexing the occurrence of negative thinking. The total PTQ score range is from 0 to 60, with a higher score indicating a frequent occurrence of negative thoughts.	Baseline to week 10
Change in well-being as measured by the Experience of Intrusions Scale (EIS)	The EIS is a 5-item questionnaire indexing the impact of intrusive thoughts regarding an emotional event with a score ranging from 0 to 20. A higher score indicating a higher level of intrusions.	Baseline to week 10
Change in well-being as measured by the short version of the perceived stress scale (PSS).	The short version of PSS is a 4-item questionnaire measuring the degree to which situations in one's life are viewed as stressful within the past month. The total score ranges from 0 to 16. A higher score indicates higher level of perceived stress.	Baseline to week 10
Change in well-being as measured by the PERMA-Profiler	PERMA-Profiler a 15-item multidimensional measure used to index well-being according to the following 5 dimensions: positive emotions, engagement, relationships, meaning, and accomplishments. The score for each subscale range from 0 to 10, with a higher score indicating better well-being.	Baseline to week 10

Collaborators and Investigators

• Sponsor: University of Miami
• Investigators: Principal Investigator: Ekaterina Ninova, Ph.D., University of Miami

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2020
• Primary Completion (Actual): August 4, 2020
• Study Completion (Actual): August 4, 2020

Study Registration Dates

• First Submitted: May 4, 2020
• First Submitted That Met QC Criteria: May 4, 2020
• First Posted (Actual): May 7, 2020

Study Record Updates

• Last Update Posted (Actual): August 17, 2020
• Last Update Submitted That Met QC Criteria: August 14, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 20200443

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No