Healthy AgingNCT05066750
What Makes People Better at Retrieving Difficult Words?
A study testing Mindful breathing in people with Healthy Aging, run by University of Colorado, Colorado Springs at 1 site in United States.
Trial summary
This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Participants will watch a video, then see definitions and try to come up with a word that fits each one. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Mindful breathing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteUnited States
- Study dates
- 23 Aug 2021to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- fluent speakers of English ages 18-30 or ages 65-80
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Participants will watch a video, then see definitions and try to come up with a word that fits each one. Participants will also complete some surveys and other measures. Collected data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to the ability to produce individual words.
Read the detailed description
This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Adult participants ages 18-30 and 65-80 will participate in videoconference calls during which a video is shown and definitions are presented. Participants will try to come up with a word that fits each definition, and then complete some surveys, including some about anxiety, mindfulness, attention, vocabulary, and demographics. Participation will take approximately 1.25 hours. Collected data will be de-identified, and the aggregate data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to peoples' ability to produce individual words.
- Conditions
- Healthy Aging
- Being tested
- Mindful breathing, Control video
- Keywords
- mindful breathing, anxiety, word retrieval
- Medical subject headings
- Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful breathingBehavioural
Participants watch a 10 minute mindful breathing video
Control videoBehavioural
Participants watch a 10 minute control video
| Study group | Role | What they receive |
|---|---|---|
| Mindful breathing video | Experimental | Participants watch a 10 minute mindful breathing video Receives: Behavioral: Mindful breathing |
| Control video | Active comparator | Participants watch a 10 minute control video Receives: Behavioral: Control video |
What is being measured
The primary outcome is the main question the study is designed to answer.
Word Retrieval Performance
Percent of trials with correct responses and percent of trials that are word retrieval failures will be measured on a task created for this purpose. Specifically, participants will try to provide words that best fit definitions, indicating when a word gets stuck on the "tip of their tongue."
Measured: During the 1.25 hour experimental session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2021
- Study start23 Aug 2021
- Primary completion20 Sep 2022
- Study completion1 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomly assigned to one of two behavioral intervention conditions before performing a word retrieval task
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Colorado Springs
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Lori James, University of Colorado, Colorado Springs
- Investigators
- Lori James, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05066750
- Sponsor's protocol ID
- 2020-005
- Other IDs
- R15AG063111-01
- Status last verified
- Apr 2024
- First submitted
- 8 Sep 2021
- Last updated
- 12 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified participant data may be posted on a website for open access to other researchers, if the publication outlet requires it, but it is not currently planned.
Study at a glance
From the registry record, last updated by the sponsor on 12 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- What Makes People Better at Retrieving Difficult Words?
- ClinicalTrials.gov ID
- NCT05066750
- Acronym / sponsor ID
- 2020-005
- Conditions
- Healthy Aging
- Keywords
- mindful breathing, anxiety, word retrieval
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- University of Colorado, Colorado SpringsUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 23 Aug 2021 (actual)
- Primary completion
- 20 Sep 2022 (actual)
- Study completion
- 1 Nov 2022 (actual)
- First posted
- 4 Oct 2021 (actual)
- Results
- Posted 12 Apr 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Participants will watch a video, then see definitions and try to come up with a word that fits each one. Participants will also complete some surveys and other measures. Collected data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to the ability to produce individual words.
Detailed description
This study is being conducted to learn more about how various personal and situational characteristics are related to the ability to produce words in response to definitions. Adult participants ages 18-30 and 65-80 will participate in videoconference calls during which a video is shown and definitions are presented. Participants will try to come up with a word that fits each definition, and then complete some surveys, including some about anxiety, mindfulness, attention, vocabulary, and demographics. Participation will take approximately 1.25 hours. Collected data will be de-identified, and the aggregate data will give researchers a better understanding of how individuals' personality and cognitive traits and setting in which word retrieval occurs relate to peoples' ability to produce individual words.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants are randomly assigned to one of two behavioral intervention conditions before performing a word retrieval task
| Arm | Type | Receives |
|---|---|---|
| Mindful breathing video | Experimental | Behavioral: Mindful breathingParticipants watch a 10 minute mindful breathing video |
| Control video | Active comparator | Behavioral: Control videoParticipants watch a 10 minute control video |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- fluent speakers of English ages 18-30 or ages 65-80
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Mindful breathingParticipants watch a 10 minute mindful breathing video | Behavioural | Mindful breathing video |
| Control videoParticipants watch a 10 minute control video | Behavioural | Control video |
Primary outcome
Word Retrieval Performance
Time frame: During the 1.25 hour experimental session
Percent of trials with correct responses and percent of trials that are word retrieval failures will be measured on a task created for this purpose. Specifically, participants will try to provide words that best fit definitions, indicating when a word gets stuck on the "tip of their tongue."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. De-identified participant data may be posted on a website for open access to other researchers, if the publication outlet requires it, but it is not currently planned.
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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.
Lori James, PhD principal investigator
University of Colorado, Colorado Springs
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful breathing in people with Healthy Aging, run by University of Colorado, Colorado Springs 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 1 inclusion and 0 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 12 Apr 2024. 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?
Yes. Results are posted in the registry (first posted 12 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Word Retrieval Performance (time frame: During the 1.25 hour experimental session). 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 12 Apr 2024.