Mindfulness and Romantic Relationship Quality (MINDv2)

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.

Study Overview

• Status: Recruiting
• Conditions: The Focus of the Study is Romantic Relationship Quality
• Intervention / Treatment: Behavioral: Mindfulness intervention

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 Type: Interventional
• Enrollment (Estimated): 274
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Marcia Ellis; Phone Number: 302-831-4591; Email: projectclosestaff@gmail.com
• Study Contact Backup: Name: Lisa Jaremka, PhD; Phone Number: 3028314810; Email: projectclosestaff@gmail.com

Study Locations

• United States
  • Delaware
    • Newark, Delaware, United States, 19716
      • Recruiting
      • University of Delaware
      • Contact: Marcia Ellis; Phone Number: 302-831-4591; Email: projectclosestaff@gmail.com
      • Contact: Lisa Jaremka, PhD; Phone Number: 3028314810; Email: projectclosestaff@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: MIndfulness; This arm was developed to increase attention towards and acceptance of current experiences.	Behavioral: Mindfulness intervention; Participants will either complete a mindfulness intervention or active control for 2 weeks on their smartphone
Active Comparator: Active Control; 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; Participants will either complete a mindfulness intervention or active control for 2 weeks on their smartphone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Romantic Relationship Quality	Assessed with well validated sel-report questionnaire, the Couples Satisfaction Index	Before and after the 2 week intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in Sleep quality	Assessed with well validated measure, the PROMIS sleep disturbance questionnaire	Before and after the 2 week intervention
Changes in Depressive symptoms	Assessed with well validated measure, the PROMIS depressive symptoms questionnire	Before and after the 2 week intervention
Changes in Blood pressure	Assessed with well validated measure, physiological assessment via a blood pressure machine	Before and after the 2 week intervention
Changes in Life satisfaction	Assessed with well validated measure, the Life Satisfaction Scale	Before and after the 2 week intervention

Collaborators and Investigators

• Sponsor: University of Delaware
• Collaborators: Carnegie Mellon University

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2019
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 21, 2019
• First Submitted That Met QC Criteria: November 23, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 2, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Mindfulness; Romantic relationship quality
• Other Study ID Numbers: 1R21AT010515-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: We will not share IPD.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No