The Focus of the Study is Romantic Relationship QualityPhase 1MINDv2NCT04177836
Mindfulness and Romantic Relationship Quality
A Phase 1 study testing Mindfulness intervention in people with The Focus of the Study is Romantic Relationship Quality, run by University of Delaware at 1 site in United States.
Trial summary
The overarching aim of this proposal is to experimentally test whether a mindfulness intervention improves relationship quality. Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- The Focus of the Study is Romantic Relationship Quality
- What is being tested?
- Mindfulness intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 274 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Nov 2019to 30 Jun 2024
- Phase
- Phase 1
- 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
Who may be able to join
- Couples living together for at least 2 years
- Both partners must be fluent in English
- Both partners cannot already engage in regular systematic mind-body practice (>2 times per week).
- Both partners must have daily access to an internet-enabled smartphone to complete the intervention
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Delaware
Newark, Delaware, 19716
Marcia Ellis, 302-831-4591, projectclosestaff@gmail.com
Lisa Jaremka, PhD, 3028314810, projectclosestaff@gmail.com
About this study
The overarching aim of this proposal is to experimentally test whether a mindfulness intervention improves relationship quality. Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research. After the 14-day period, couples will attend a lab visit and provide relationship quality data.
Read the detailed description
Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Thus, both partners will either complete the mindfulness intervention (developed to increase attention towards and acceptance of current experiences) or a relaxation-based active treatment comparison intervention (developed to parallel the structure of the mindfulness intervention without the attention towards or acceptance of present experiences). Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research, which demonstrated that the mindfulness intervention reduced stress reactivity and improved daily well-being. After the 14-day period, couples will attend a lab visit and provide multi-method relationship quality data.
- Being tested
- Mindfulness intervention
- Keywords
- Romantic relationship quality, Mindfulness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness interventionBehavioural
Participants will either complete a mindfulness intervention or active control for 2 weeks on their smartphone
| Study group | Role | What they receive |
|---|---|---|
| MIndfulness | Experimental | This arm was developed to increase attention towards and acceptance of current experiences. Receives: Behavioral: Mindfulness intervention |
| Active Control | Active comparator | This arm is a relaxation-based active treatment comparison intervention, developed to parallel the structure of the mindfulness intervention without the attention towards or acceptance of present experiences. Receives: Behavioral: Mindfulness intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in Romantic Relationship Quality
Assessed with well validated sel-report questionnaire, the Couples Satisfaction Index
Measured: Before and after the 2 week intervention
Secondary outcomes (4)
Changes in Sleep quality
Assessed with well validated measure, the PROMIS sleep disturbance questionnaire
Measured: Before and after the 2 week intervention
Changes in Depressive symptoms
Assessed with well validated measure, the PROMIS depressive symptoms questionnire
Measured: Before and after the 2 week intervention
Changes in Blood pressure
Assessed with well validated measure, physiological assessment via a blood pressure machine
Measured: Before and after the 2 week intervention
Changes in Life satisfaction
Assessed with well validated measure, the Life Satisfaction Scale
Measured: Before and after the 2 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start4 Nov 2019
- Primary completion30 Jun 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for The Focus of the Study is Romantic Relationship QualityStudies 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 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- There are 2 arms to this intervention - mindfulness and active control.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 274 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Delaware
- Sponsor type
- University, hospital or other
- Collaborators
- Carnegie Mellon University
- Responsible party
- Principal investigator, Lisa Jaremka, University of Delaware
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04177836
- Sponsor's protocol ID
- 1R21AT010515-01
- Acronym
- MINDv2
- Status last verified
- Feb 2024
- First submitted
- 21 Nov 2019
- Last updated
- 6 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We will not share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mindfulness and Romantic Relationship Quality
- ClinicalTrials.gov ID
- NCT04177836
- Acronym / sponsor ID
- MINDv2 / 1R21AT010515-01
- Keywords
- Romantic relationship quality, Mindfulness
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 274 participants (estimated)
- Lead sponsor
- University of DelawareUniversity, hospital or other
- Collaborators
- Carnegie Mellon University
- Study start
- 4 Nov 2019 (actual)
- Primary completion
- 30 Jun 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 26 Nov 2019 (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 overarching aim of this proposal is to experimentally test whether a mindfulness intervention improves relationship quality. Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research. After the 14-day period, couples will attend a lab visit and provide relationship quality data.
Detailed description
Romantic couples from the community will be randomly assigned to one of two arms: mindfulness vs. active control. Thus, both partners will either complete the mindfulness intervention (developed to increase attention towards and acceptance of current experiences) or a relaxation-based active treatment comparison intervention (developed to parallel the structure of the mindfulness intervention without the attention towards or acceptance of present experiences). Both interventions will be completed on a smart-phone for 14 days using identical intervention activities as our existing published research, which demonstrated that the mindfulness intervention reduced stress reactivity and improved daily well-being. After the 14-day period, couples will attend a lab visit and provide multi-method relationship quality data.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- There are 2 arms to this intervention - mindfulness and active control.
| Arm | Type | Receives |
|---|---|---|
| MIndfulness | Experimental | Behavioral: Mindfulness interventionThis arm was developed to increase attention towards and acceptance of current experiences. |
| Active Control | Active comparator | Behavioral: Mindfulness interventionThis arm is a relaxation-based active treatment comparison intervention, developed to parallel the structure of the mindfulness intervention without the attention towards or acceptance of present experiences. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Couples living together for at least 2 years
- Both partners must be fluent in English
- Both partners cannot already engage in regular systematic mind-body practice (>2 times per week).
- Both partners must have daily access to an internet-enabled smartphone to complete the intervention
Key exclusion criteria (1 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 |
|---|---|---|
| Mindfulness interventionParticipants will either complete a mindfulness intervention or active control for 2 weeks on their smartphone | Behavioural | Active Control, MIndfulness |
Primary outcome
Changes in Romantic Relationship Quality
Time frame: Before and after the 2 week intervention
Assessed with well validated sel-report questionnaire, the Couples Satisfaction Index
4 secondary outcomes
Changes in Sleep quality
Time frame: Before and after the 2 week intervention
Changes in Depressive symptoms
Time frame: Before and after the 2 week intervention
Changes in Blood pressure
Time frame: Before and after the 2 week intervention
Changes in Life satisfaction
Time frame: Before and after the 2 week intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2024.
- Individual participant dataSharing planned: No. We will not share IPD.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mindfulness intervention in people with The Focus of the Study is Romantic Relationship Quality, run by University of Delaware 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 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: status not confirmed, as of the sponsor's last update on 6 Feb 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marcia Ellis (302-831-4591, projectclosestaff@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Romantic Relationship Quality (time frame: Before and after the 2 week intervention). 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 6 Feb 2024.