Mindfulness Training for Seniors

Well Aging Clinical Trial

Official title:

Mindfulness Training for Older Adults During the COVID-19 Pandemic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04378803
• Other study ID #: 20200443
• Status: Completed
• Phase: N/A
• Start date: May 13, 2020
• Est. completion date: August 4, 2020

Study information

• Verified date: August 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: August 4, 2020
• Est. primary completion date: August 4, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years to 95 Years

Eligibility

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.

Related Conditions & MeSH terms

• Well Aging

Intervention

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.

Locations

Country	Name	City	State
United States	University of Miami	Coral Gables	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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