Marital ConflictNCT03332875
OurRelationship.Com Effectiveness Study
A study testing OurRelationship Online Program in people with Marital Conflict and Relationship, Marital, run by University of Miami.
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. Read more about this study
- Who is it for?
- Ages 18 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- Marital Conflict, Relationship, Marital
- What is being tested?
- OurRelationship Online Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 712 participants
- Where
- No sites listed yet
- Study dates
- 15 Jun 2014to 1 Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
About this 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:
- 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.
- 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)
- Determine completion rates and effectiveness of the program once payments for participation have been removed.
- 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.
- Conditions
- Marital Conflict, Relationship, Marital
- Being tested
- OurRelationship Online Program
- Keywords
- OurRelationship, Couple therapy, Internet, Marriage Counseling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OurRelationship Online ProgramBehavioural
OurRelationship.com is an online program designed to improve distressed romantic relationships.
| Study group | Role | What they receive |
|---|---|---|
| OurRelationship - 1 Coach Call | Experimental | OurRelationship online program plus a single call with a coach. Receives: Behavioral: OurRelationship Online Program |
| OurRelationship - 4 Coach Calls | Experimental | OurRelationship online program plus four calls with a coach. Receives: Behavioral: OurRelationship Online Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change between baseline and the end of the intervention (approx. 2 months later)
Secondary outcomes (2)
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).
Measured: Change between baseline and the end of the intervention (approx. 2 months later)
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.
Measured: Change between baseline and the end of the intervention (approx. 2 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2017
- Study start15 Jun 2014
- Primary completion1 Jul 2015
- Study completion1 Jul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Marital ConflictStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Couples are randomized to receive either one call with a coach or four calls with a coach.
- Masking
- None (open label)
- Enrolment
- 712 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Brian Doss, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03332875
- Sponsor's protocol ID
- 20140405
- Status last verified
- Nov 2017
- First submitted
- 23 Oct 2017
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified participant data available to qualified professionals.
Publications
Roddy MK, Rothman K, Doss BD. A randomized controlled trial of different levels of coach support in an online intervention for relationship distress. Behav Res Ther. 2018 Nov;110:47-54. doi: 10.1016/j.brat.2018.09.002. Epub 2018 Sep 13.
PubMed 30240874
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OurRelationship.Com Effectiveness Study
- ClinicalTrials.gov ID
- NCT03332875
- Acronym / sponsor ID
- 20140405
- Conditions
- Marital Conflict, Relationship, Marital
- Keywords
- OurRelationship, Couple therapy, Internet, Marriage Counseling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 712 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- 15 Jun 2014 (actual)
- Primary completion
- 1 Jul 2015 (actual)
- Study completion
- 1 Jul 2015 (actual)
- First posted
- 6 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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)
- Determine completion rates and effectiveness of the program once payments for participation have been removed.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Couples are randomized to receive either one call with a coach or four calls with a coach.
| Arm | Type | Receives |
|---|---|---|
| OurRelationship - 1 Coach Call | Experimental | Behavioral: OurRelationship Online ProgramOurRelationship online program plus a single call with a coach. |
| OurRelationship - 4 Coach Calls | Experimental | Behavioral: OurRelationship Online ProgramOurRelationship online program plus four calls with a coach. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OurRelationship Online ProgramOurRelationship.com is an online program designed to improve distressed romantic relationships. | Behavioural | OurRelationship - 1 Coach Call, OurRelationship - 4 Coach Calls |
Primary outcome
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.
2 secondary outcomes
Depressive symptoms
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- Derived from this study: PubMed 30240874Roddy MK, Rothman K, Doss BD. A randomized controlled trial of different levels of coach support in an online intervention for relationship distress. Behav Res Ther. 2018 Nov;110:47-54. doi: 10.1016/j.brat.2018.09.002. Epub 2018 Sep 13.
- Individual participant dataSharing planned: Undecided. De-identified participant data available to qualified professionals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing OurRelationship Online Program in people with Marital Conflict and Relationship, Marital, run by University of Miami.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Relationship satisfaction (time frame: Change between baseline and the end of the intervention (approx. 2 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03332875, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.