Cognitive ChangeNCT04589195
Measuring Mindfulness Application
A study testing Mindfulness Training in people with Cognitive Change, run by University of Miami at 1 site in United States.
Trial summary
The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Cognitive Change
- What is being tested?
- Mindfulness Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Oct 2021to 26 Dec 2021
- 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 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Individuals who are between 18 and 64 years of age.
- Individuals who are fluent English speakers.
- Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.
- Individuals who are willing and able to consent to participate in the study.
- Individuals who are in the South Florida ROTC program.
Who cannot join
- 1.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: Measurement of an Application - Based Delivery of Mindfulness Training Program Content
The purpose of the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.
- Conditions
- Cognitive Change
- Being tested
- Mindfulness Training
- Keywords
- Mindfulness Training, Cognitive Training, Psychological Health
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness TrainingBehavioural
The intervention includes four weeks of MT application use, accessed via phone or computer, consisting of 15-minute daily mindfulness practices 5 days a week.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness Training (MT) Group | Experimental | Participants will receive four weeks of MT. Receives: Behavioral: Mindfulness Training |
| Wait List MT Group | Active comparator | Participants will receive four weeks of MT training after a five week washout period. Receives: Behavioral: Mindfulness Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Positive Affect
Positive affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS positive sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
Measured: Baseline to Week 5
Change in Negative Affect
Negative affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS negative sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
Measured: Baseline to Week 5
Change in Perceived Stress
Perceived Stress will be measured with the Perceived Stress Scale (PSS). PSS has a range of scores from 0 to 40, with a higher score indicates a higher level of perceived stress.
Measured: Baseline to Week 5
Secondary outcomes (2)
Change in Sustained Attention Response Task (SART) scores
The SART involves pressing a button to frequently presented non-target trials and withholding the button press to the infrequent target trials. The participants can have a total score between 0 and 100%, with a higher score indicating butter sustained attention.
Measured: Baseline to Week 5
Change in Cognitive Failures
Cognitive Failures will be measured with the Cognitive Failures Questionnaire (CFQ). CFQ has a range of scores from 0 to 100, with a higher score indicating more cognitive failures.
Measured: Baseline to Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2020
- Study start11 Oct 2021
- Primary completion29 Nov 2021
- Study completion26 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cognitive ChangeStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amishi Jha, University of Miami
- Investigators
- Amishi Jha, PhD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04589195
- Sponsor's protocol ID
- 20201140
- Status last verified
- Jan 2022
- First submitted
- 9 Oct 2020
- Last updated
- 14 Jan 2022
- 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 14 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of an Application - Based Delivery of Mindfulness Training Program Content
- ClinicalTrials.gov ID
- NCT04589195
- Acronym / sponsor ID
- 20201140
- Conditions
- Cognitive Change
- Keywords
- Mindfulness Training, Cognitive Training, Psychological Health
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 11 Oct 2021 (actual)
- Primary completion
- 29 Nov 2021 (actual)
- Study completion
- 26 Dec 2021 (actual)
- First posted
- 19 Oct 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 the research study is to learn more about how ROTC cadets may engage with mindfulness training program content that is delivered through a smartphone or website application. Mindfulness training program content includes mindfulness practices that foster attention and awareness.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness Training (MT) Group | Experimental | Behavioral: Mindfulness TrainingParticipants will receive four weeks of MT. |
| Wait List MT Group | Active comparator | Behavioral: Mindfulness TrainingParticipants will receive four weeks of MT training after a five week washout period. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individuals who are between 18 and 64 years of age.
- Individuals who are fluent English speakers.
- Individuals who have access to either an Apple or Android smart phone and a desktop or laptop computer, are able to adequately and independently use both devices, and have Internet connection.
- Individuals who are willing and able to consent to participate in the study.
- Individuals who are in the South Florida ROTC program.
Key exclusion criteria (1 listed)
- 1.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 TrainingThe intervention includes four weeks of MT application use, accessed via phone or computer, consisting of 15-minute daily mindfulness practices 5 days a week. | Behavioural | Mindfulness Training (MT) Group, Wait List MT Group |
Primary outcome
Change in Positive Affect
Time frame: Baseline to Week 5
Positive affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS positive sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher positive mood.
Change in Negative Affect
Time frame: Baseline to Week 5
Negative affect will be measured with the 10-item version of the Positive and Negative Affect Schedule (PANAS-10). The PANAS negative sub-scale has 5 items and a range of scores from 5 to 25, with a higher score indicating a higher negative mood.
Change in Perceived Stress
Time frame: Baseline to Week 5
Perceived Stress will be measured with the Perceived Stress Scale (PSS). PSS has a range of scores from 0 to 40, with a higher score indicates a higher level of perceived stress.
2 secondary outcomes
Change in Sustained Attention Response Task (SART) scores
Time frame: Baseline to Week 5
Change in Cognitive Failures
Time frame: Baseline to Week 5
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 14 Jan 2022.
- Individual participant dataSharing planned: No
Related trials for Cognitive Change
Recruiting
A Clinical Trial to Evaluate the Effects of Adrenal Adapt on Sleep Quality, Daytime Energy, Stress Resilience, and Cognitive Performance.
Improves Daytime Energy Levels, Reduces Afternoon Energy Crashes and Midday Fatigue
Recruiting
Milk Fat Globule Membrane-Enhanced RUTF for Children With Severe Acute Malnutrition
Severe Acute Malnutrition, Cognitive Impairment
RecruitingObservational study
Looking at Cognitive and Brain Changes in People With Lymphoma Receiving CAR-T Therapy
Lymphoma Receiving CAR-T Therapy
Enrolling by invitation
Brain Heath Service for Prevention of AD
Alzheimer, Cognitive Unimpaired
Enrolling by invitation
Effects of Long-Duration Spaceflight on General and Spatial Cognition and Its Neural Basis
Brain Structure, Cognitive Performance
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.
Amishi Jha, PhD 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 in people with Cognitive Change, 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 5 inclusion and 1 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 14 Jan 2022. 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 Positive Affect (time frame: Baseline to Week 5). The study lists 3 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 14 Jan 2022.