Trial Outcomes & Findings for Social Media Intervention for Postpartum Depression (NCT NCT02355067)
NCT ID: NCT02355067
Last Updated: 2021-03-09
Results Overview
Percentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
40 participants
Primary outcome timeframe
8 weeks
Results posted on
2021-03-09
Participant Flow
Participant milestones
| Measure |
Social Media Format
Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group.
|
In-Person Format
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
|---|---|---|
|
Overall Study
STARTED
|
20
|
20
|
|
Overall Study
COMPLETED
|
12
|
12
|
|
Overall Study
NOT COMPLETED
|
8
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Social Media Intervention for Postpartum Depression
Baseline characteristics by cohort
| Measure |
Social Media Format
n=12 Participants
Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group.
|
In-Person Format
n=12 Participants
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
26.4 years
STANDARD_DEVIATION 1.9 • n=99 Participants
|
26.3 years
STANDARD_DEVIATION 1.8 • n=107 Participants
|
26.3 years
STANDARD_DEVIATION 1.9 • n=206 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
12 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Beck Depression Inventory II
|
30.7 units on a scale
n=99 Participants
|
25.7 units on a scale
n=107 Participants
|
28.2 units on a scale
n=206 Participants
|
|
Parenting Sense of Competency
|
67.8 units on a scale
n=99 Participants
|
78.3 units on a scale
n=107 Participants
|
73.0 units on a scale
n=206 Participants
|
PRIMARY outcome
Timeframe: 8 weeksPercentage of participants who attend each group session or check in online weekly. This is averaged over the course of the 8-week program.
Outcome measures
| Measure |
Social Media Format
n=12 Participants
Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group.
|
In-Person Format
n=12 Participants
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
|---|---|---|
|
Attendance
|
83.3 percentage of participants
Interval 67.0 to 100.0
|
3.3 percentage of participants
Interval 0.0 to 33.0
|
PRIMARY outcome
Timeframe: 12 weeksParticipants report concerning their overall program effects-Satisfaction Questionnaire. The scale ranges from 1-5 with higher values representing higher satisfaction.
Outcome measures
| Measure |
Social Media Format
n=9 Participants
Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group.
|
In-Person Format
n=4 Participants
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
|---|---|---|
|
Acceptability
|
4.5 units on a scale
Interval 1.0 to 5.0
|
4.5 units on a scale
Interval 1.0 to 5.0
|
SECONDARY outcome
Timeframe: 12 weeksThe BDI-II is a 21-item self-report tool that measures the severity of depression and includes two subscales: cognitive and somatic. It has been well validated, with scores 14-19 indicating mild depression, 20-28 moderate depression, and 29-63 severe depression. The full range of the BDI-II is 0-64.
Outcome measures
| Measure |
Social Media Format
n=12 Participants
Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group.
|
In-Person Format
n=8 Participants
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
|---|---|---|
|
Beck Depression Inventory (BDI-II)
|
20.2 units on a scale
Interval 17.0 to 40.0
|
23.3 units on a scale
Interval 14.0 to 33.0
|
SECONDARY outcome
Timeframe: 12 weeksThe Parenting Sense of Competence scale measures parental competence on two dimensions: Satisfaction and Efficacy. It is a 17 item Likert-scale questionnaire (on a 6 point scale ranging from strongly agree \[1\] to strongly disagree \[6\]), with nine questions under Satisfaction and seven under Efficacy. Satisfaction section examines the parents' anxiety, motivation and frustration, while the Efficacy section looks at the parents' competence, capability levels, and problem-solving abilities in their parental role. Higher scores represent better parenting sense of competency. The full range of the score is 17-102.
Outcome measures
| Measure |
Social Media Format
n=12 Participants
Social Media Intervention for women with postpartum depression (PPD) symptoms
Social Media Intervention: These women will participate in the intervention through the online Facebook group.
|
In-Person Format
n=8 Participants
Traditional In-Person Intervention for Women with postpartum depression (PPD)
Traditional In-Person Intervention: These women will participate in the intervention through a traditional weekly meeting of a group in-person.
|
|---|---|---|
|
Parenting Sense of Competency (PSOC) Scale
|
76.3 units on a scale
Interval 54.0 to 97.0
|
73.6 units on a scale
Interval 60.0 to 92.0
|
Adverse Events
Social Media Format
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
In-Person Format
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place