Trial Outcomes & Findings for Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention (NCT NCT03880032)
NCT ID: NCT03880032
Last Updated: 2024-02-15
Results Overview
Data reported is the number of participants with Common Mental Disorders (CMDs), which is defined as a woman having either high anxiety or clinical depression at the time of follow-up. Both CMDs, anxiety was indicated by moderate to severe symptoms on the anxiety portion of the Hospital and Anxiety Scale (HADS). A cutoff of \>10 was used as the threshold for moderate to severe levels of anxiety. A Major Depressive Episode (MDE) was measured with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID), which is a semi-structured interview used to make major Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses. Its scoring will be based on case or non-case basis.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
1200 participants
Primary outcome timeframe
6 weeks postpartum
Results posted on
2024-02-15
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy (CBT) Intervention for Anxiety
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Usual care will also be enhanced by hospital staff receiving additional training in mental health treatment and counseling. Transportation will be facilitated to assist participants in attending appointments and medically indicated ultrasounds will be paid for (as in the intervention group).
|
|---|---|---|
|
Overall Study
STARTED
|
600
|
600
|
|
Overall Study
COMPLETED
|
380
|
375
|
|
Overall Study
NOT COMPLETED
|
220
|
225
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy Intervention for Anxiety
n=600 Participants
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
n=600 Participants
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Usual care will also be enhanced by hospital staff receiving additional training in mental health treatment and counseling. Transportation will be facilitated to assist participants in attending appointments and medically indicated ultrasounds will be paid for (as in the intervention group).
|
Total
n=1200 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
25.08 Years
n=93 Participants
|
25.46 Years
n=4 Participants
|
25.3 Years
n=27 Participants
|
|
Sex: Female, Male
Female
|
600 Participants
n=93 Participants
|
600 Participants
n=4 Participants
|
1200 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
600 Participants
n=93 Participants
|
600 Participants
n=4 Participants
|
1200 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Pakistan
|
600 Participants
n=93 Participants
|
600 Participants
n=4 Participants
|
1200 Participants
n=27 Participants
|
|
Baseline Hospital Anxiety and Depression Score (HADS) of >=8 on the anxiety subscale
|
600 participants
n=93 Participants
|
600 participants
n=4 Participants
|
1200 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 6 weeks postpartumData reported is the number of participants with Common Mental Disorders (CMDs), which is defined as a woman having either high anxiety or clinical depression at the time of follow-up. Both CMDs, anxiety was indicated by moderate to severe symptoms on the anxiety portion of the Hospital and Anxiety Scale (HADS). A cutoff of \>10 was used as the threshold for moderate to severe levels of anxiety. A Major Depressive Episode (MDE) was measured with the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders (SCID), which is a semi-structured interview used to make major Axis I Diagnostic and Statistical Manual of Mental Disorders (DSM) diagnoses. Its scoring will be based on case or non-case basis.
Outcome measures
| Measure |
Cognitive Behavioral Therapy Intervention for Anxiety
n=600 Participants
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
n=600 Participants
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Reminders were given, provider visits facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the intervention group).
|
|---|---|---|
|
Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression).
|
57 Participants
|
178 Participants
|
SECONDARY outcome
Timeframe: at birthPopulation: The analysis for the secondary outcomes on children is 720 rather than 755 for the primary outcome on mothers. The reason for this is because the sample size differed for these two groups for a number of reasons (e.g. women who did not carry their pregnancies to term).
Number of infants born with \<37 weeks' gestation
Outcome measures
| Measure |
Cognitive Behavioral Therapy Intervention for Anxiety
n=362 Participants
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
n=358 Participants
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Reminders were given, provider visits facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the intervention group).
|
|---|---|---|
|
Number of Preterm Births
|
79 infants
|
68 infants
|
SECONDARY outcome
Timeframe: at birthPopulation: The analysis for the secondary outcomes on children is 720 rather than 755 for the primary outcome on mothers. The reason for this is because the sample size differed for these two groups for a number of reasons (e.g. women who did not carry their pregnancies to term).
\<10th% for gestational age at birth compared to the reference population
Outcome measures
| Measure |
Cognitive Behavioral Therapy Intervention for Anxiety
n=362 Participants
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
n=358 Participants
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Reminders were given, provider visits facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the intervention group).
|
|---|---|---|
|
Small-for-gestational Age Birth
|
89 infants
|
105 infants
|
SECONDARY outcome
Timeframe: at birthPopulation: The analysis for the secondary outcomes on children is 720 rather than 755 for the primary outcome on mothers. The reason for this is because the sample size differed for these two groups for a number of reasons (e.g. women who did not carry their pregnancies to term).
weight of ≤2500 grams
Outcome measures
| Measure |
Cognitive Behavioral Therapy Intervention for Anxiety
n=362 Participants
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
n=358 Participants
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Reminders were given, provider visits facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the intervention group).
|
|---|---|---|
|
Low Birthweight
|
46 infants
|
53 infants
|
Adverse Events
Cognitive Behavioral Therapy Intervention for Anxiety
Serious events: 48 serious events
Other events: 0 other events
Deaths: 0 deaths
Enhanced Usual Care
Serious events: 42 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Cognitive Behavioral Therapy Intervention for Anxiety
n=600 participants at risk
Pregnant women experiencing anxiety randomized to the Happy Mother Healthy Baby (HMHB) intervention receive a CBT-based psychosocial intervention (with six core and up to six booster sessions). HMHB is a facility-based intervention delivered by non-specialist providers. It is aimed to raise psychosocial awareness and facilitate positive change inter personal wellbeing, social support, and bonding with their baby during pregnancy. It addresses with relapse prevention, planning for the baby's arrival, and in management of emotional challenges in the early postnatal period. Family member/s will be invited to attend 3 core sessions.
Cognitive Behavioral Therapy Intervention for Anxiety: Happy Mother Healthy Baby (HMHB) is a CBT-based psychosocial intervention for expectant women experiencing anxiety during their pregnancy. Strategies such as empathetic listening, thought challenging, behavior activation, problem management, take-home exercises, and family involvement are employed by HMHB.
|
Enhanced Usual Care
n=600 participants at risk
Women randomized to the control group will receive enhanced usual care (EUC). The World Health Organization (WHO) recommends 8 antenatal visits for a positive pregnancy experience, the number of visits our EUC control group participants will receive (depending on their gestational week). Usual care will also be enhanced by hospital staff receiving additional training in mental health treatment and counseling. Transportation will be facilitated to assist participants in attending appointments and medically indicated ultrasounds will be paid for (as in the intervention group).
|
|---|---|---|
|
Injury, poisoning and procedural complications
Serious Adverse Event
|
8.0%
48/600 • Number of events 48 • 5 months
None of the participants died, only there were some neo-natal deaths which were reported as Severe Adverse Event.
|
7.0%
42/600 • Number of events 42 • 5 months
None of the participants died, only there were some neo-natal deaths which were reported as Severe Adverse Event.
|
Other adverse events
Adverse event data not reported
Additional Information
Pamela Surkan
Johns Hopkins Bloomberg School of Public Health
Phone: 4105027396
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place