Relationship, Marital Clinical Trial
Official title:
OurRelationship.Com Effectiveness Study
Verified date | November 2017 |
Source | University of Miami |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Miami |
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) |
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