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OpenTrials
Completed

NCT Number: NCT04378803

Mindfulness Training for Seniors

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

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Key information

Conditions

Well Aging

Age range

60 year–95 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Coral Gables, Florida, 33146, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindfulness training (MT) Connect

Behavioral

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  1. Change in attention

    Time frame: Baseline to week 10

    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.

  2. Change in well-being as measured by the Perseverative Thought Questionnaire (PTQ)

    Time frame: Baseline to week 10

    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.

  3. Change in well-being as measured by the Experience of Intrusions Scale (EIS)

    Time frame: Baseline to week 10

    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.

  4. Change in well-being as measured by the short version of the perceived stress scale (PSS).

    Time frame: Baseline to week 10

    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.

  5. Change in well-being as measured by the PERMA-Profiler

    Time frame: Baseline to week 10

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Official study title

Mindfulness Training for Older Adults During the COVID-19 Pandemic

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
May 7, 2020
Registry last updated
Aug 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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