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OpenTrials
Completed

NCT Number: NCT03332875

OurRelationship.Com Effectiveness Study

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.

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Key information

Age range

18 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

OurRelationship Online Program

Behavioral

OurRelationship.com is an online program designed to improve distressed romantic relationships.

Primary outcomes

  1. Relationship satisfaction

    Time frame: Change between baseline and the end of the intervention (approx. 2 months later)

    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.

Secondary outcomes

  1. Depressive symptoms

    Time frame: Change between baseline and the end of the intervention (approx. 2 months later)

    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).

  2. Anxiety symptoms

    Time frame: Change between baseline and the end of the intervention (approx. 2 months later)

    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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 6, 2017
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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