NCT04177836

Brief 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. 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
274

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Nov 2019

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 4, 2019

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 26, 2019

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2024

Completed
Last Updated

February 6, 2024

Status Verified

February 1, 2024

Enrollment Period

4.7 years

First QC Date

November 21, 2019

Last Update Submit

February 2, 2024

Conditions

Keywords

Romantic relationship qualityMindfulness

Outcome Measures

Primary Outcomes (1)

  • Changes in Romantic Relationship Quality

    Assessed with well validated sel-report questionnaire, the Couples Satisfaction Index

    Before and after the 2 week intervention

Secondary Outcomes (4)

  • Changes in Sleep quality

    Before and after the 2 week intervention

  • Changes in Depressive symptoms

    Before and after the 2 week intervention

  • Changes in Blood pressure

    Before and after the 2 week intervention

  • Changes in Life satisfaction

    Before and after the 2 week intervention

Study Arms (2)

MIndfulness

EXPERIMENTAL

This arm was developed to increase attention towards and acceptance of current experiences.

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.

Behavioral: Mindfulness intervention

Interventions

Participants will either complete a mindfulness intervention or active control for 2 weeks on their smartphone

Active ControlMIndfulness

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

RECRUITING

Central Study Contacts

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
The participant and the people interacting with participants will be blind to condition.
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: There are 2 arms to this intervention - mindfulness and active control.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 21, 2019

First Posted

November 26, 2019

Study Start

November 4, 2019

Primary Completion

June 30, 2024

Study Completion

June 30, 2024

Last Updated

February 6, 2024

Record last verified: 2024-02

Data Sharing

IPD Sharing
Will not share

We will not share IPD.

Locations