Trial Outcomes & Findings for Empirically-Based Couple Interventions on the Web: Serving the Underserved (NCT NCT03292692)
NCT ID: NCT03292692
Last Updated: 2018-02-12
Results Overview
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.
COMPLETED
NA
600 participants
Pre (0 weeks), Mid (3 weeks), and Post (approximately 6 weeks)
2018-02-12
Participant Flow
Participant milestones
| Measure |
OurRelationship
Online Intervention
OurRelationship: Online intervention with coach support
|
Waitlist Control
2 month waiting period before couples can receive intervention
|
|---|---|---|
|
Overall Study
STARTED
|
302
|
298
|
|
Overall Study
COMPLETED
|
264
|
260
|
|
Overall Study
NOT COMPLETED
|
38
|
38
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Empirically-Based Couple Interventions on the Web: Serving the Underserved
Baseline characteristics by cohort
| Measure |
OurRelationship
n=302 Participants
Online Intervention
OurRelationship: Online intervention with coach support
|
Waitlist Control
n=298 Participants
2 month waiting period before couples can receive intervention
|
Total
n=600 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
36.01 years
STANDARD_DEVIATION 9.54 • n=5 Participants
|
36.22 years
STANDARD_DEVIATION 9.62 • n=7 Participants
|
36.11 years
STANDARD_DEVIATION 9.58 • n=5 Participants
|
|
Sex: Female, Male
Female
|
151 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
151 Participants
n=5 Participants
|
149 Participants
n=7 Participants
|
300 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
30 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
59 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
272 Participants
n=5 Participants
|
269 Participants
n=7 Participants
|
541 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
62 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
119 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
209 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
421 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
13 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
302 Participants
n=5 Participants
|
298 Participants
n=7 Participants
|
600 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Pre (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.
Outcome measures
| Measure |
OurRelationship
n=302 Participants
Online Intervention
OurRelationship: Online intervention with coach support
|
Waitlist Control
n=298 Participants
2 month waiting period before couples can receive intervention
|
|---|---|---|
|
Relationship Satisfaction
Post-intervention
|
12.08 units on a scale
Standard Deviation 4.42
|
9.51 units on a scale
Standard Deviation 4.82
|
|
Relationship Satisfaction
Pre-intervention
|
8.335 units on a scale
Standard Deviation 3.915
|
8.37 units on a scale
Standard Deviation 4.025
|
|
Relationship Satisfaction
Mid-intervention
|
10.63 units on a scale
Standard Deviation 4.335
|
9.555 units on a scale
Standard Deviation 4.53
|
SECONDARY outcome
Timeframe: Pre (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).
Outcome measures
| Measure |
OurRelationship
n=302 Participants
Online Intervention
OurRelationship: Online intervention with coach support
|
Waitlist Control
n=298 Participants
2 month waiting period before couples can receive intervention
|
|---|---|---|
|
Relationship Confidence
Pre-intervention
|
7.94 units on a scale
Standard Deviation 2.565
|
7.58 units on a scale
Standard Deviation 3.185
|
|
Relationship Confidence
Mid-intervention
|
8.92 units on a scale
Standard Deviation 2.495
|
8.045 units on a scale
Standard Deviation 3.215
|
|
Relationship Confidence
Post-intervention
|
9.635 units on a scale
Standard Deviation 2.325
|
8.05 units on a scale
Standard Deviation 3.335
|
SECONDARY outcome
Timeframe: Pre (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.
Outcome measures
| Measure |
OurRelationship
n=302 Participants
Online Intervention
OurRelationship: Online intervention with coach support
|
Waitlist Control
n=298 Participants
2 month waiting period before couples can receive intervention
|
|---|---|---|
|
Depressive Symptoms
Pre-intervention
|
10.82 units on a scale
Standard Deviation 4.24
|
10.42 units on a scale
Standard Deviation 4.34
|
|
Depressive Symptoms
Post-intervention
|
9.105 units on a scale
Standard Deviation 3.22
|
9.895 units on a scale
Standard Deviation 4.185
|
SECONDARY outcome
Timeframe: Pre (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.
Outcome measures
| Measure |
OurRelationship
n=302 Participants
Online Intervention
OurRelationship: Online intervention with coach support
|
Waitlist Control
n=298 Participants
2 month waiting period before couples can receive intervention
|
|---|---|---|
|
Anxiety Symptoms
Pre-intervention
|
7.995 units on a scale
Standard Deviation 5.385
|
8.24 units on a scale
Standard Deviation 5.645
|
|
Anxiety Symptoms
Post-intervention
|
4.875 units on a scale
Standard Deviation 4.5
|
6.11 units on a scale
Standard Deviation 5.135
|
Adverse Events
OurRelationship
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place