Trial Outcomes & Findings for Oxytocin for Couples Conflict Resolution (NCT NCT02941692)
NCT ID: NCT02941692
Last Updated: 2018-10-12
Results Overview
Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
66 participants
Primary outcome timeframe
Frequency of distress maintaining attrbibutions per 10 minutes
Results posted on
2018-10-12
Participant Flow
Participant milestones
| Measure |
Oxytocin
Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.
Oxytocin
|
Placebo
Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.
Placebo: Placebo for Oxytocin
|
|---|---|---|
|
Overall Study
STARTED
|
32
|
34
|
|
Overall Study
COMPLETED
|
32
|
34
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
Baseline characteristics by cohort
| Measure |
Oxytocin
n=32 Participants
Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.
Oxytocin
|
Placebo
n=28 Participants
Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.
Placebo: Placebo for Oxytocin
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.97 years
STANDARD_DEVIATION 10.17 • n=5 Participants
|
32.21 years
STANDARD_DEVIATION 9.73 • n=7 Participants
|
32.08 years
STANDARD_DEVIATION 9.88 • n=5 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
|
14 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
|
30 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
|
|
Sex: Female, Male
Male
|
16 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
|
14 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
|
30 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multi-level modeling approach. one couple was excluded from analyses due to questionable reliability of data.
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
2 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
3 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
0 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
1 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
0 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
0 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
14 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
31 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
|
Race (NIH/OMB)
White
|
13 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
11 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
24 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
1 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
1 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
0 Participants
n=7 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
0 Participants
n=5 Participants • Two same-sex couples were excluded from analyses to accommodate multilevel modeling analyses. One couple was excluded from analyses due to unreliability of data.
|
PRIMARY outcome
Timeframe: Frequency of distress maintaining attrbibutions per 10 minutesPopulation: Analyses were limited to heterosexual couples with reliable data reporting in order to accommodate the data analytic approach (i.e., multilevel modeling).
Couples' conflict resolution discussions are video recorded and coded according to an observational coding system: the Rapid Marital Interaction Coding System, which assesses the frequency of behaviors (distress maintaining attributions and relationship enhancing attributions) during the 10 minute conflict resolution discussion. This variable is operationalized as the number of instances of distress maintaining attributions during each of two ten minute conflict resolution discussions.
Outcome measures
| Measure |
Oxytocin
n=32 Participants
Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.
Oxytocin
|
Placebo
n=28 Participants
Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.
Placebo: Placebo for Oxytocin
|
|---|---|---|
|
Change in Frequency of Distress Maintaining Attributions
|
.81 distress maintaining attributions
Standard Deviation 2.67
|
-.48 distress maintaining attributions
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: Measured at 7 time points: Baseline, immediately before and after Conflict Resolution Task #1, Immediately after Conflict Resolution Task #2, and at 15, 30, and 60 minutes following the completion of Conflict Resolution task #2.Population: Three couples (6 total participants) were not included in analyses.
Cortisol samples are collected at baseline, pre-post each conflict resolution discussion, and at 15, 30, and 60 minute post-task intervals.
Outcome measures
| Measure |
Oxytocin
n=28 Participants
Participants randomized to this condition will receive 40 IU dose of intranasal oxytocin.
Oxytocin
|
Placebo
n=32 Participants
Participants randomized to this condition will receive a matching dose of intranasal saline spray as placebo.
Placebo: Placebo for Oxytocin
|
|---|---|---|
|
Change in Salivary Cortisol (μg/dL)
Time 1 (Baseline)
|
.28 μg/dL
Standard Deviation .18
|
.30 μg/dL
Standard Deviation .20
|
|
Change in Salivary Cortisol (μg/dL)
Time 2 (Pre Conflict Discussion #1)
|
.25 μg/dL
Standard Deviation .14
|
.29 μg/dL
Standard Deviation .18
|
|
Change in Salivary Cortisol (μg/dL)
Time 3 (Post Conflict Discussion #1)
|
.18 μg/dL
Standard Deviation .11
|
.21 μg/dL
Standard Deviation .12
|
|
Change in Salivary Cortisol (μg/dL)
Time 4 (Post Conflit Discussion #2)
|
.17 μg/dL
Standard Deviation .11
|
.22 μg/dL
Standard Deviation .16
|
|
Change in Salivary Cortisol (μg/dL)
Time 5 (15 minutes Post Conflict Discussion)
|
.16 μg/dL
Standard Deviation .10
|
.22 μg/dL
Standard Deviation .20
|
|
Change in Salivary Cortisol (μg/dL)
Time 6 (30 minutes Post Conflict Discussion)
|
.17 μg/dL
Standard Deviation .10
|
.22 μg/dL
Standard Deviation .18
|
|
Change in Salivary Cortisol (μg/dL)
Time 7 (60 Minutes Post Conflict Discussion)
|
.16 μg/dL
Standard Deviation .08
|
.19 μg/dL
Standard Deviation .13
|
Adverse Events
Oxytocin
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Julianne Flanagan
Medical University of South Carolina
Phone: 843-792-5569
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place