OurRelationship.Com Effectiveness Study

November 1, 2017 updated by: Brian Doss, University of Miami

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

712

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: OurRelationship - 1 Coach Call
OurRelationship online program plus a single call with a coach.
Behavioral: OurRelationship Online Program
OurRelationship.com is an online program designed to improve distressed romantic relationships.
Experimental: OurRelationship - 4 Coach Calls
OurRelationship online program plus four calls with a coach.
Behavioral: OurRelationship Online Program
OurRelationship.com is an online program designed to improve distressed romantic relationships.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Change between baseline and the end of the intervention (approx. 2 months later)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Change between baseline and the end of the intervention (approx. 2 months later)
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.
Change between baseline and the end of the intervention (approx. 2 months later)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2014

Primary Completion (Actual)

July 1, 2015

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 23, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 6, 2017

Last Update Submitted That Met QC Criteria

November 1, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 20140405

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

De-identified participant data available to qualified professionals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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