MindfulnessPEPNCT05271851
Tailoring Mindfulness Interventions for Families Managing Chronic Health Conditions
An observational study of Mindfulness and Chronic Disease, run by University of Maryland, College Park at 1 site in United States.
Trial summary
This is not an intervention or treatment study. It is an observational qualitative data study about tailoring a mindfulness intervention to assist families managing chronic health conditions. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mindfulness, Chronic Disease
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2020to 1 Jul 2021
- Phase
- Observational
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member
Who may be able to join
- English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member
Who cannot join
- unable to complete an audio interview in English lasting 30-60 minutes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: PEP (Parent and Child-Informed, Environmentally-Responsive Pediatric Asthma) Study
This is not an intervention or treatment study. It is an observational qualitative data study about tailoring a mindfulness intervention to assist families managing chronic health conditions.
Read the detailed description
This is not an intervention or treatment study. It is an observational qualitative data study. Collecting information from virtual audio only interviews from between 30 and 40 US adults about whether a mindfulness intervention would assist families managing chronic health conditions; and if so, how should it be tailored to meet their needs.
- Conditions
- Mindfulness, Chronic Disease
- Medical subject headings
- Chronic Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
what families managing chronic illness want in a mindfulness intervention
structured open ended questions analyzed with grounded theory- no quantitative data will be captured
Measured: 30 to 60 minute interview
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2022
- Study start1 Mar 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MindfulnessStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, College Park
- Sponsor type
- University, hospital or other
- Collaborators
- University of Wisconsin, Madison, University of Maryland, Baltimore, University of Memphis
- Responsible party
- Sponsor
- Investigators
- Robin Puett, PhD, Principal investigator, UMD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05271851
- Sponsor's protocol ID
- AT010207
- Acronym
- PEP
- Status last verified
- Mar 2022
- First submitted
- 27 Feb 2022
- Last updated
- 31 Mar 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 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PEP (Parent and Child-Informed, Environmentally-Responsive Pediatric Asthma) Study
- ClinicalTrials.gov ID
- NCT05271851
- Acronym / sponsor ID
- PEP / AT010207
- Conditions
- Mindfulness, Chronic Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of Maryland, College ParkUniversity, hospital or other
- Collaborators
- University of Wisconsin, Madison, University of Maryland, Baltimore, University of Memphis
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 9 Mar 2022 (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.
This is not an intervention or treatment study. It is an observational qualitative data study about tailoring a mindfulness intervention to assist families managing chronic health conditions.
Detailed description
This is not an intervention or treatment study. It is an observational qualitative data study. Collecting information from virtual audio only interviews from between 30 and 40 US adults about whether a mindfulness intervention would assist families managing chronic health conditions; and if so, how should it be tailored to meet their needs.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member
Key inclusion criteria (1 listed)
- English speaking and either a long-time mindfulness practitioner/instructor or an adult managing a chronic health condition for yourself or a close family member
Key exclusion criteria (1 listed)
- unable to complete an audio interview in English lasting 30-60 minutes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
what families managing chronic illness want in a mindfulness intervention
Time frame: 30 to 60 minute interview
structured open ended questions analyzed with grounded theory- no quantitative data will be captured
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 31 Mar 2022.
- Individual participant dataSharing planned: No
Related trials for Mindfulness
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Recruiting
Addressing Nocturia in Older Women Utilizing Behavioral Sleep Intervention and Brief Mindfulness
Nocturia, Insomnia
Recruiting
Bonding Before Birth: A mHealth Intervention for First-time Expectant Couples
Anxiety, Pregnancy
Not yet recruiting
Physiology of Liberation
Psychophysiological Reactivity and Recovery
RecruitingPhase 2
Targeting Treatment-Resistant OUD With Ketamine-Assisted Mindfulness Oriented Recovery Enhancement
Opioid Use Disorder
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.
Robin Puett, PhD principal investigator
UMD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mindfulness and Chronic Disease, run by University of Maryland, College Park 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 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 31 Mar 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?
what families managing chronic illness want in a mindfulness intervention (time frame: 30 to 60 minute interview). 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 31 Mar 2022.