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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03292692
Enrollment
600
Registered
2017-09-25
Start date
2013-08-13
Completion date
2014-10-18
Last updated
2018-02-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Marital Conflict, Relationship, Marital

Brief 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. 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.

Interventions

BEHAVIORALOurRelationship

Online intervention with coach support

Sponsors

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
CollaboratorNIH
University of California, Los Angeles
CollaboratorOTHER
University of Washington
CollaboratorOTHER
University of Miami
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
21 Years to 64 Years
Healthy volunteers
Yes

Inclusion criteria

* 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)

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Relationship SatisfactionPre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)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.

Secondary

MeasureTime frameDescription
Relationship ConfidencePre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)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).
Depressive SymptomsPre (0 weeks) and Post (approximately 6 weeks)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.
Anxiety SymptomsPre (0 weeks) and Post (approximately 6 weeks)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.

Participant flow

Participants by arm

ArmCount
OurRelationship
Online Intervention OurRelationship: Online intervention with coach support
302
Waitlist Control
2 month waiting period before couples can receive intervention
298
Total600

Baseline characteristics

CharacteristicOurRelationshipTotalWaitlist Control
Age, Continuous36.01 years
STANDARD_DEVIATION 9.54
36.11 years
STANDARD_DEVIATION 9.58
36.22 years
STANDARD_DEVIATION 9.62
Ethnicity (NIH/OMB)
Hispanic or Latino
30 Participants59 Participants29 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
272 Participants541 Participants269 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
3 Participants7 Participants4 Participants
Race (NIH/OMB)
Asian
13 Participants25 Participants12 Participants
Race (NIH/OMB)
Black or African American
62 Participants119 Participants57 Participants
Race (NIH/OMB)
More than one race
13 Participants22 Participants9 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
2 Participants6 Participants4 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants0 Participants0 Participants
Race (NIH/OMB)
White
209 Participants421 Participants212 Participants
Region of Enrollment
United States
302 Participants600 Participants298 Participants
Sex: Female, Male
Female
151 Participants300 Participants149 Participants
Sex: Female, Male
Male
151 Participants300 Participants149 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 3020 / 298
serious
Total, serious adverse events
0 / 3020 / 298

Outcome results

Primary

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.

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

ArmMeasureGroupValue (MEAN)Dispersion
OurRelationshipRelationship SatisfactionPre-intervention8.335 units on a scaleStandard Deviation 3.915
OurRelationshipRelationship SatisfactionMid-intervention10.63 units on a scaleStandard Deviation 4.335
OurRelationshipRelationship SatisfactionPost-intervention12.08 units on a scaleStandard Deviation 4.42
Waitlist ControlRelationship SatisfactionPre-intervention8.37 units on a scaleStandard Deviation 4.025
Waitlist ControlRelationship SatisfactionMid-intervention9.555 units on a scaleStandard Deviation 4.53
Waitlist ControlRelationship SatisfactionPost-intervention9.51 units on a scaleStandard Deviation 4.82
p-value: <0.00195% CI: [0.279, 0.465]Regression, Linear
Secondary

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.

Time frame: Pre (0 weeks) and Post (approximately 6 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
OurRelationshipAnxiety SymptomsPre-intervention7.995 units on a scaleStandard Deviation 5.385
OurRelationshipAnxiety SymptomsPost-intervention4.875 units on a scaleStandard Deviation 4.5
Waitlist ControlAnxiety SymptomsPre-intervention8.24 units on a scaleStandard Deviation 5.645
Waitlist ControlAnxiety SymptomsPost-intervention6.11 units on a scaleStandard Deviation 5.135
p-value: 0.00295% CI: [-1.871, -0.417]Regression, Linear
Secondary

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.

Time frame: Pre (0 weeks) and Post (approximately 6 weeks)

ArmMeasureGroupValue (MEAN)Dispersion
OurRelationshipDepressive SymptomsPre-intervention10.82 units on a scaleStandard Deviation 4.24
OurRelationshipDepressive SymptomsPost-intervention9.105 units on a scaleStandard Deviation 3.22
Waitlist ControlDepressive SymptomsPre-intervention10.42 units on a scaleStandard Deviation 4.34
Waitlist ControlDepressive SymptomsPost-intervention9.895 units on a scaleStandard Deviation 4.185
p-value: <0.00195% CI: [-2.974, -1.324]Regression, Linear
Secondary

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).

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

ArmMeasureGroupValue (MEAN)Dispersion
OurRelationshipRelationship ConfidencePre-intervention7.94 units on a scaleStandard Deviation 2.565
OurRelationshipRelationship ConfidenceMid-intervention8.92 units on a scaleStandard Deviation 2.495
OurRelationshipRelationship ConfidencePost-intervention9.635 units on a scaleStandard Deviation 2.325
Waitlist ControlRelationship ConfidencePre-intervention7.58 units on a scaleStandard Deviation 3.185
Waitlist ControlRelationship ConfidenceMid-intervention8.045 units on a scaleStandard Deviation 3.215
Waitlist ControlRelationship ConfidencePost-intervention8.05 units on a scaleStandard Deviation 3.335
p-value: <0.00195% CI: [0.105, 0.235]Regression, Linear

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026