Well AgingNCT04378803
Mindfulness Training for Seniors
A study testing Mindfulness training (MT) Connect in people with Well Aging, run by University of Miami at 1 site in United States.
Trial summary
The purpose of this research study is to learn more about how mindfulness training may influence thinking and feeling. Read more about this study
- Who is it for?
- Ages 60 to 95 yearsHealthy volunteers can take part
- Conditions the study is for
- Well Aging
- What is being tested?
- Mindfulness training (MT) Connect
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- 13 May 2020to 4 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 95 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Well Aging
- Being tested
- Mindfulness training (MT) Connect
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness training (MT) ConnectBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mindfulness training (MT) Connect |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to week 10
Secondary outcomes (5)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2020
- Study start13 May 2020
- Primary completion4 Aug 2020
- Study completion4 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- The wait-list control group will receive the training program at a later point.
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ekaterina Denkova, University of Miami
- Investigators
- Ekaterina Ninova, Ph.D., Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04378803
- Sponsor's protocol ID
- 20200443
- Status last verified
- Aug 2020
- First submitted
- 4 May 2020
- Last updated
- 17 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness Training for Older Adults During the COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04378803
- Acronym / sponsor ID
- 20200443
- Conditions
- Well Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 4 Aug 2020 (actual)
- Study completion
- 4 Aug 2020 (actual)
- First posted
- 7 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to learn more about how mindfulness training may influence thinking and feeling.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The wait-list control group will receive the training program at a later point.
| Arm | Type | Receives |
|---|---|---|
| Mindfulness training (MT) group | Experimental | Behavioral: Mindfulness training (MT) ConnectReceives 4 weeks of mindfulness training followed by a testing session. Then, 4 weeks of no-training interval followed by a testing session. |
| Wait-list control (WLC) group | Experimental | Behavioral: Mindfulness training (MT) ConnectReceives 4 weeks of no-training interval followed by a testing session. Then, 4 weeks of mindfulness training followed by a testing session. |
Who may qualify
- Ages
- 60 to 95 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness training (MT) ConnectMT 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. | Behavioural | Mindfulness training (MT) group, Wait-list control (WLC) group |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
5 secondary outcomes
Change in attention
Time frame: Baseline to week 10
Change in well-being as measured by the Perseverative Thought Questionnaire (PTQ)
Time frame: Baseline to week 10
Change in well-being as measured by the Experience of Intrusions Scale (EIS)
Time frame: Baseline to week 10
Change in well-being as measured by the short version of the perceived stress scale (PSS).
Time frame: Baseline to week 10
Change in well-being as measured by the PERMA-Profiler
Time frame: Baseline to week 10
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ekaterina Ninova, Ph.D. principal investigator
University of Miami
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training (MT) Connect in people with Well Aging, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in mindfulness skills as measured by Five-Facet Mindfulness Questionnaire (5FMQ) (time frame: Baseline to week 10). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2020.