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Relationship, MaritalNCT03292692

Empirically-Based Couple Interventions on the Web: Serving the Underserved

A study testing OurRelationship in people with Relationship, Marital and Marital Conflict, run by University of Miami.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Although several empirically-supported interventions to prevent and treat relationship distress have been developed, the majority of couples - especially high-risk couples - do not seek these face-to-face interventions. Read more about this study

Who is it for?
Ages 21 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Relationship, Marital, Marital Conflict
What is being tested?
OurRelationship
Could I receive a placebo?
No, everyone receives an active treatment
How many people
600 participants
Where
No sites listed yet
Study dates
13 Aug 2013to 18 Oct 2014
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 21 to 64 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Currently in a heterosexual relationship
  • Currently married, engaged, or cohabiting for at least 6 months
  • At least one partner scoring in distressed range of relationship satisfaction (or both partners > 0.5 SD of population mean of distress).
  • Living in the United States
  • Both partners ages 21-64 (inclusive)

Who cannot join

  • Severe Intimate Partner Violence in last 3 months
  • Moderate to severe suicidal ideation in last 3 months
  • Concrete plans to divorce
  • Ongoing affair
  • Ongoing couple therapy (or refusal to seek couple therapy for 3 months)

About this study

Although several empirically-supported interventions to prevent and treat relationship distress have been developed, the majority of couples - especially high-risk couples - do not seek these face-to-face interventions. However, our pilot data indicate that large numbers of couples will seek self-administered assistance for their relationship. Additionally, unlike many in-person interventions, couples seeking self-help resources tend to have higher levels of relationship distress. Thus, to improve the reach of couple interventions, this project will translate a leading empirically-supported intervention targeting early signs of relationship distress into a Web-based format. This intervention will consist of individualized feedback and professionally-filmed video clips tailored to a couple's specific needs. By intervening effectively with a large number of couples, the resulting Web-based intervention has the potential to have a population-level impact on relationship distress, divorce, and resulting child difficulties.

In the proposed project, building off our previous pilot studies, effective translation of this in-person intervention into a Web-based format will be ensured by conducting two additional intensive pilot studies. Once final changes have been made to the website and Web-based intervention, 300 couples will be randomly assigned to a wait-list control group or an online intervention. All couples will be assessed for the initial two months; intervention couples will be assessed for one year. This project will: 1) demonstrate that couples randomly assigned to the online intervention will report higher levels of individual, child, and relationship functioning than those in the wait-list control group; 2) document the mechanisms of both active conditions; and 3) show that initial gains in those assigned to the intervention are largely maintained through one-year follow-up.

Being tested
OurRelationship

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OurRelationshipBehavioural

    Also called OurRelationship.com

    Online intervention with coach support

Study groups in NCT03292692
Study groupRoleWhat they receive
OurRelationshipExperimentalOnline Intervention
Receives: Behavioral: OurRelationship
Waitlist ControlNo intervention2 month waiting period before couples can receive intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Relationship Satisfaction

    Relationship satisfaction as measured by the total scale on the four-item version of the Couple Satisfaction Index (Funk \& Rogge, 2007; doi: 10.1037/0893-3200.21.4.572). Scores on this measure range from 0-21, with higher scores indicating greater satisfaction.

    Measured: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)

Secondary outcomes (3)

  1. Relationship Confidence

    Relationship confidence as measured by 2 items from the Confidence Scale ("I believe we can handle whatever conflicts will arise in the future" and "I feel good about our prospects to make this relationship work"). Scored ranged from 0 to 12, with higher scores indicate more confidence.Cronbach's alpha = .88. These two items have been used in previous studies of couples to assess change (e.g., http://dx.doi .org/10.1177/0192513X08324388).

    Measured: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)

  2. Depressive Symptoms

    Depressive symptoms as measured by the 10-item Center for Epidemiologic Studies-Depression (CES-D) Scale (Cole, Rabin, Smith, \& Kaufman, 2004). The total score was used, with possible scores ranging from 0-30. Higher scores on this measure indicate greater depressive symptoms.

    Measured: Pre (0 weeks) and Post (approximately 6 weeks)

  3. Anxiety Symptoms

    Anxiety symptoms as measured by the Generalized Anxiety Disorder 7-item scale (GAD-7; Spitzer, Kroenke, Williams, \& Löwe, 2006). The range of the measure is 0 to 49, with higher scores indicating greater anxiety symptoms. Cronbach's alpha in the present sample was .91.

    Measured: Pre (0 weeks) and Post (approximately 6 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Sep 2017
  2. Study start13 Aug 2013
  3. Primary completion18 Oct 2014
  4. Study completion18 Oct 2014

Resources

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
Masking
None (open label)
Enrolment
600 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03292692
Sponsor's protocol ID
20120378
Other IDs
R01HD059802
Status last verified
Feb 2018
First submitted
20 Sep 2017
Last updated
12 Feb 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: De-identified data available to qualified researchers upon request.

Publications

  • Doss BD, Cicila LN, Georgia EJ, Roddy MK, Nowlan KM, Benson LA, Christensen A. A randomized controlled trial of the web-based OurRelationship program: Effects on relationship and individual functioning. J Consult Clin Psychol. 2016 Apr;84(4):285-96. doi: 10.1037/ccp0000063. Epub 2016 Jan 25.

    PubMed 26999504

  • Roddy MK, Georgia EJ, Doss BD. Couples with Intimate Partner Violence Seeking Relationship Help: Associations and Implications for Self-Help and Online Interventions. Fam Process. 2018 Jun;57(2):293-307. doi: 10.1111/famp.12291. Epub 2017 Apr 20.

    PubMed 28425562

  • Roddy MK, Stamatis CA, Rothman K, Doss BD. Mechanisms of change in a brief, online relationship intervention. J Fam Psychol. 2020 Feb;34(1):57-67. doi: 10.1037/fam0000569. Epub 2019 Aug 5.

    PubMed 31380690

  • Doss BD, Roddy MK, Llabre MM, Georgia Salivar E, Jensen-Doss A. Improvements in coparenting conflict and child adjustment following an online program for relationship distress. J Fam Psychol. 2020 Feb;34(1):68-78. doi: 10.1037/fam0000582. Epub 2019 Aug 5.

    PubMed 31380688

Questions about this trial

What is this clinical trial studying?

A study testing OurRelationship in people with Relationship, Marital and Marital Conflict, 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 5 inclusion and 5 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 12 Feb 2018. 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?

Yes. Results are posted in the registry (first posted 12 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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: Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)). 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 NCT03292692, which also lists 4 linked publications.

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 12 Feb 2018.

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