MINDv2: Mindfulness and Romantic Relationship Quality

• Sponsor: University of Delaware (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04177836
• Collaborator: Carnegie Mellon University (Other)
• Enrollment: 178
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 44.8
• Patients Per Site Per Month: 4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
The Focus of the Study is Romantic Relationship Quality	Behavioral: Mindfulness intervention	Phase 1

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

• Study Type: Interventional
• Anticipated Enrollment: 178 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: There are 2 arms to this intervention - mindfulness and active control.There are 2 arms to this intervention - mindfulness and active control.
• Masking: Single (Participant)
• Masking Description: The participant and the people interacting with participants will be blind to condition.
• Primary Purpose: Basic Science
• Official Title: Mindfulness and Romantic Relationship Quality
• Actual Study Start Date: Nov 4, 2019
• Anticipated Primary Completion Date: Jul 31, 2023
• Anticipated Study Completion Date: Jul 31, 2023

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Changes in Romantic Relationship Quality [Before and after the 2 week intervention]

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

Secondary Outcome Measures

1. Changes in Sleep quality [Before and after the 2 week intervention]

   Assessed with well validated measure, the PROMIS sleep disturbance questionnaire

2. Changes in Depressive symptoms [Before and after the 2 week intervention]

   Assessed with well validated measure, the PROMIS depressive symptoms questionnire

3. Changes in Blood pressure [Before and after the 2 week intervention]

   Assessed with well validated measure, physiological assessment via a blood pressure machine

4. Changes in Life satisfaction [Before and after the 2 week intervention]

   Assessed with well validated measure, the Life Satisfaction Scale

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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:

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Delaware	Newark	Delaware	United States	19716

Sponsors and Collaborators

• University of Delaware
• Carnegie Mellon University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Lisa Jaremka, Principal Investigator, University of Delaware
• ClinicalTrials.gov Identifier: NCT04177836
• Other Study ID Numbers: 1R21AT010515-01
• First Posted: Nov 26, 2019
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lisa Jaremka, Principal Investigator, University of Delaware: Romantic relationship quality; Mindfulness

Study Results

No Results Posted as of Aug 11, 2022