Mindfulness Training for Seniors

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

Official Title
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Mindfulness Training for Older Adults During the COVID-19 Pandemic

Conditions
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Well Aging

Intervention / Treatment
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* Behavioral: Mindfulness training (MT) Connect


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: The wait-list control group will receive the training program at a later point.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mindfulness training (MT) group<br>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<br>* 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.<br>|
| Experimental: Wait-list control (WLC) group<br>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<br>* 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.<br>|

What is the study measuring?
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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 |