Mindfulness Training for Seniors

NCT04378803 | Completed

• 1 other identifier: 20200443
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Well Aging

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (5)

• 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 Experience of Intrusions Scale (EIS)

  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 Arms (2)

Mindfulness training (MT) group

EXPERIMENTAL

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

Wait-list control (WLC) group

EXPERIMENTAL

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

Interventions

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.

Mindfulness training (MT) group; Wait-list control (WLC) group

Eligibility Criteria

• Age: 60 Years - 95 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Coral Gables, Florida, 33146, United States

Location

Study Officials

• Ekaterina Ninova, Ph.D.

  University of Miami

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assistant Professor

Model Details: The wait-list control group will receive the training program at a later point.

Study Record Dates

• First Submitted: May 4, 2020
• First Posted: May 7, 2020
• Study Start: May 13, 2020
• Primary Completion: August 4, 2020
• Study Completion: August 4, 2020
• Last Updated: August 17, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)