Trial Outcomes & Findings for PREPP: Preventing Postpartum Depression (NCT NCT03283254)

Results Overview

Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores range from 0 to 30, with higher scores indicate more depressive symptoms (worse outcome).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

216 participants

Primary outcome timeframe

Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Results posted on

2025-09-26

Participant Flow

Only mothers were enrolled, and infants were assessed for efficacy

Participant milestones

Participant milestones
Measure	Practical Resources for Effective Postpartum (PREPP) Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.
Overall Study STARTED	88	87
Overall Study 6-week Postpartum Session	69	66
Overall Study 12-week Postpartum Session	52	52
Overall Study 16-week Postpartum Session	57	57
Overall Study COMPLETED	57	57
Overall Study NOT COMPLETED	31	30

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

PREPP: Preventing Postpartum Depression

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Practical Resources for Effective Postpartum (PREPP) n=88 Participants Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual n=87 Participants Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.	Total n=175 Participants Total of all reporting groups
Age, Continuous	31.15 years STANDARD_DEVIATION 5.51 • n=5 Participants	30.16 years STANDARD_DEVIATION 6.8 • n=7 Participants	30.66 years STANDARD_DEVIATION 6.19 • n=5 Participants
Sex: Female, Male Female	88 Participants n=5 Participants	87 Participants n=7 Participants	175 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	54 Participants n=5 Participants	54 Participants n=7 Participants	108 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	34 Participants n=5 Participants	33 Participants n=7 Participants	67 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	0 Participants n=5 Participants	2 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants	4 Participants n=7 Participants	7 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	15 Participants n=5 Participants	11 Participants n=7 Participants	26 Participants n=5 Participants
Race (NIH/OMB) White	22 Participants n=5 Participants	15 Participants n=7 Participants	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	7 Participants n=5 Participants	3 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	40 Participants n=5 Participants	52 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment United States	88 participants n=5 Participants	87 participants n=7 Participants	175 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Population: Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session.

Maternal mood: Postpartum Depression Symptoms will be measured by Edinburgh Postnatal Depression Scale (EPDS). The EPDS is a 10-item questionnaire that was developed to identify women who have postpartum depression. Items of the scale correspond to various clinical depression symptoms, such as guilt feeling, sleep disturbance, low energy, anhedonia, and suicidal ideation. Overall assessment is done by total score, which is determined by adding together the scores for each of the 10 items. Scores range from 0 to 30, with higher scores indicate more depressive symptoms (worse outcome).

Outcome measures

Outcome measures
Measure	Practical Resources for Effective Postpartum (PREPP) n=88 Participants Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual n=87 Participants Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.
Score on the Edinburgh Postnatal Depression Scale (EPDS) Baseline	5.04 score on a scale Standard Error 0.49	4.36 score on a scale Standard Error 3.51
Score on the Edinburgh Postnatal Depression Scale (EPDS) 6 week	4.43 score on a scale Standard Error 0.46	4.04 score on a scale Standard Error 0.42
Score on the Edinburgh Postnatal Depression Scale (EPDS) 12 week	3.51 score on a scale Standard Error 0.39	3.74 score on a scale Standard Error 0.42
Score on the Edinburgh Postnatal Depression Scale (EPDS) 16 week	3.69 score on a scale Standard Error 0.41	4.04 score on a scale Standard Error 0.44

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Population: Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session.

Maternal perception of sleep quality: The Pittsburgh Sleep Quality Index (PSQI) is a self-rated questionnaire that assesses sleep quality and disturbances over a 1-month time interval. A total of 19 individual items generate 7 "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. Scores range from 0 to 21, where lower scores indicate a healthier sleep quality (better outcome).

Outcome measures

Outcome measures
Measure	Practical Resources for Effective Postpartum (PREPP) n=88 Participants Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual n=87 Participants Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.
Score on the Pittsburgh Sleep Quality Index (PSQI) Baseline	7.01 score on a scale Standard Error 0.37	6.55 score on a scale Standard Error 0.35
Score on the Pittsburgh Sleep Quality Index (PSQI) 6 week	7.21 score on a scale Standard Error 0.43	8.16 score on a scale Standard Error 0.47
Score on the Pittsburgh Sleep Quality Index (PSQI) 12 week	5.73 score on a scale Standard Error 0.40	6.48 score on a scale Standard Error 0.44
Score on the Pittsburgh Sleep Quality Index (PSQI) 16 week	5.88 score on a scale Standard Error 0.39	6.06 score on a scale Standard Error 0.40

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Population: Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session.

The Hamilton Rating Scale for Depression (HRSD), also called the Hamilton Depression Rating Scale (HDRS), sometimes also abbreviated as HAM-D, is a multiple-item questionnaire used to provide an indication of depression, and as a guide to evaluate recovery. The patient is rated on 24 items scored either on a 3-point (0-2) or 5-point (0-4) Likert-type scale. Total scores range from 0 to 74 with a lower score indicating a better outcome.

Outcome measures

Outcome measures
Measure	Practical Resources for Effective Postpartum (PREPP) n=88 Participants Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual n=87 Participants Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.
Score on HRSD-24 Baseline	4.09 score on a scale Standard Error 0.39	3.16 score on a scale Standard Error 0.32
Score on HRSD-24 6 week	3.23 score on a scale Standard Error 0.34	2.99 score on a scale Standard Error 0.32
Score on HRSD-24 12 week	2.99 score on a scale Standard Error 0.34	3.31 score on a scale Standard Error 0.37
Score on HRSD-24 16 week	2.74 score on a scale Standard Error 0.31	2.73 score on a scale Standard Error 0.31

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Population: Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session.

The nine-item Patient Health Questionnaire (PHQ-9) is a depressive symptom scale and diagnostic tool introduced in 2001 to screen adult patients in primary care settings. The instrument assesses for the presence and severity of depressive symptoms and a possible depressive disorder. It is scored by simply adding up the individual items' scores. Scores range from 0 to 27 with a lower score indicating a better outcome.

Outcome measures

Outcome measures
Measure	Practical Resources for Effective Postpartum (PREPP) n=88 Participants Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual n=87 Participants Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.
Score on the PHQ-9 16 week	4.50 score on a scale Standard Error 0.41	4.08 score on a scale Standard Error 0.38
Score on the PHQ-9 Baseline	6.36 score on a scale Standard Error 0.49	5.64 score on a scale Standard Error 0.45
Score on the PHQ-9 6 week	5.21 score on a scale Standard Error 0.44	5.42 score on a scale Standard Error 0.46
Score on the PHQ-9 12 week	4.13 score on a scale Standard Error 0.39	5.19 score on a scale Standard Error 0.47

PRIMARY outcome

Timeframe: Baseline, 6 weeks, 12 weeks, and 16 weeks postpartum

Population: Data for this outcome was only collected from participants who were able to attend a session to receive the intervention. Data was not collected from participants who did not attend a session.

The scale consists of 14 items designed to assess the severity of a patient's anxiety. The patient is rated by on 14 items scored on a 5-point (0-4) Likert-type scale. Total scores range from 0 to 56 with a lower score indicating a better outcome.

Outcome measures

Outcome measures
Measure	Practical Resources for Effective Postpartum (PREPP) n=88 Participants Participants received the experimental PREPP intervention.	Enhanced Treatment as Usual n=87 Participants Participants received enhanced treatment as usual (ETAU): Postpartum Depression psychoeducation, mood assessments, and referral for treatment if needed or requested by the participant.
Hamilton Anxiety Scale (HRSA) 12 week	3.01 score on a scale Standard Error 0.35	3.30 score on a scale Standard Error 0.38
Hamilton Anxiety Scale (HRSA) 16 week	2.93 score on a scale Standard Error 0.34	2.94 score on a scale Standard Error 0.34
Hamilton Anxiety Scale (HRSA) Baseline	4.09 score on a scale Standard Error 0.41	3.63 score on a scale Standard Error 0.37
Hamilton Anxiety Scale (HRSA) 6 week	3.01 score on a scale Standard Error 0.33	3.09 score on a scale Standard Error 0.34

PRIMARY outcome

Timeframe: 28-32 weeks gestation (prenatal), 34-39 weeks gestation (prenatal), 6 weeks postpartum, 16 weeks postpartum

Population: Data for this outcome could not be collected from participants who did not wear the activity monitor continuously for 7 days

Sleep Efficiency (SEact) was measured by an activity monitor worn by the participants continuously over 7 days. SEact is reported as a percent of time spent asleep during the total time spent in bed.