OurRelationship.Com Effectiveness Study

Relationship, Marital Clinical Trial

Official title:

OurRelationship.Com Effectiveness Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332875
• Other study ID #: 20140405
• Status: Completed
• Phase: N/A
• First received: October 23, 2017
• Last updated: November 1, 2017
• Start date: June 15, 2014
• Est. completion date: July 1, 2015

Study information

• Verified date: November 2017
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose this study is to determine the continued reach and effectiveness of the OurRelationship.com program once paid advertising and payment for participation ceases. The answer to this question is essential to determining the sustainability of web-based interventions for couples. Specifically, this study has four aims:

1. Examine continued level of initial interest in the study, as measured by number of initial visits to the website, time spent on the page, and number of couples signing up for the study.

2. Measure any changes in the characteristics of the individuals expressing interest in the study, including demographics (e.g., race, ethnicity, education), relationship functioning (e.g., relationship satisfaction, previous help-seeking), and individual functioning (e.g., depression, anxiety)

3. Determine completion rates and effectiveness of the program once payments for participation have been removed.

4. Determine whether having a single Skype/phone call with a coach (rather than the four calls that were used in the NIH trial) significantly degrades completion rates.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 712
• Est. completion date: July 1, 2015
• Est. primary completion date: July 1, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• Currently in a heterosexual relationship

• Married, Engaged, or living with partner for 6 months or more

• Living in the United States

• Both partners score at least 0.5 standards below the community mean on relationship satisfaction

Exclusion Criteria:

• Clinically significant intimate partner violence

• Younger than 18 or older than 64 years of age

• Reporting infidelity in last three months

• Reporting severe suicidal ideation in last three months

Related Conditions & MeSH terms

• Marital Conflict
• Relationship, Marital

Intervention

Behavioral:
• OurRelationship Online Program
OurRelationship.com is an online program designed to improve distressed romantic relationships.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relationship satisfaction	Relationship satisfaction as measured by the Couple Satisfaction Inventory, 16-item (Funk & Rogge, 2007; http://dx.doi.org/10.1037/0893-3200.21.4.572). Higher scores on this scale indicate greater satisfaction. Total scores range from 0 to 81, with a score below 51.5 indicating clinical distress. Internal consistency (alpha = 0.98) and convergent validity are strong.	Change between baseline and the end of the intervention (approx. 2 months later)
Secondary	Depressive symptoms	Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies Depression Scale (CES-D-10). Higher scores on this scale indicate greater depressive symptoms. The scale has been shown to have excellent sensitivity, specificity, and internal consistency (e.g., Irwin, Artin, & Oxman, 1999; doi:10.1001/archinte.159.15.1701).	Change between baseline and the end of the intervention (approx. 2 months later)
Secondary	Anxiety symptoms	Anxiety symptoms, as measured by the Generalized Anxiety Disorder Scale-7 (GAD-7; Spitzer, Kroenke, Williams, & Lowe; DOI: 10.1001/archinte.166.10.1092). Scores on this measure range from 0 to 21, with higher scores indicating greater anxiety symptoms. Sensitivity (89%), specificity (82%), and criterion validity are excellent for this measure.	Change between baseline and the end of the intervention (approx. 2 months later)