Happy Mother-Healthy Baby: An Anxiety-focused Early Prenatal Intervention (HMHB)

• ClinicalTrials.gov Identifier: NCT03880032
• Recruitment Status: Completed
• First Posted: March 19, 2019
• Results First Posted: February 15, 2024
• Last Update Posted: February 15, 2024
• Sponsor: Johns Hopkins Bloomberg School of Public Health
• Collaborator: Human Development Research Foundation, Pakistan
• Information provided by (Responsible Party): Johns Hopkins Bloomberg School of Public Health

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Conditions: Postpartum Depression; Small for Gestational Age at Delivery; Preterm Birth; Anxiety; Birth Weight
• Intervention: Behavioral: Cognitive Behavioral Therapy Intervention for Anxiety
• Enrollment: 1200

Participant Flow

Recruitment Details
Pre-assignment Details

Arm/Group Title	Cognitive Behavioral Therapy (CBT) Intervention for Anxiety	Enhanced Usual Care
Arm/Group Description	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.	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).
Period Title: Overall Study
Started	600	600
Completed	380	375
Not Completed	220	225

Baseline Characteristics

Arm/Group Title		Cognitive Behavioral Therapy Intervention for Anxiety	Enhanced Usual Care	Total
Arm/Group Description		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.	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 of all reporting groups
Overall Number of Baseline Participants		600	600	1200
Baseline Analysis Population Description		[Not Specified]
Age, Continuous; Mean (Full Range); Unit of measure: Years
	Number Analyzed	600 participants	600 participants	1200 participants
		25.08; (18 to 40)	25.46; (18 to 40)	25.3; (18 to 40)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	600 participants	600 participants	1200 participants
	Female	600 100.0%	600 100.0%	1200 100.0%
	Male	0 0.0%	0 0.0%	0 0.0%
Race (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	600 participants	600 participants	1200 participants
	American Indian or Alaska Native	0 0.0%	0 0.0%	0 0.0%
	Asian	600 100.0%	600 100.0%	1200 100.0%
	Native Hawaiian or Other Pacific Islander	0 0.0%	0 0.0%	0 0.0%
	Black or African American	0 0.0%	0 0.0%	0 0.0%
	White	0 0.0%	0 0.0%	0 0.0%
	More than one race	0 0.0%	0 0.0%	0 0.0%
	Unknown or Not Reported	0 0.0%	0 0.0%	0 0.0%
Region of Enrollment; Measure Type: Count of Participants; Unit of measure: Participants
Pakistan	Number Analyzed	600 participants	600 participants	1200 participants
		600 100.0%	600 100.0%	1200 100.0%
Baseline Hospital Anxiety and Depression Score (HADS) of >=8 on the anxiety subscale; Measure Type: Number; Unit of measure: Participants
	Number Analyzed	600 participants	600 participants	1200 participants
		600	600	1200

Outcome Measures

1. Primary Outcome

Title	Number of Participants With Combined Common Mental Disorders (CMDs, i.e. Anxiety and Depression).
Description	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.
Time Frame	6 weeks postpartum

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cognitive Behavioral Therapy Intervention for Anxiety	Enhanced Usual Care
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	600	600
Measure Type: Count of Participants; Unit of Measure: Participants
	57 9.5%	178 29.7%

2. Secondary Outcome

Title	Number of Preterm Births
Description	Number of infants born with <37 weeks' gestation
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Cognitive Behavioral Therapy Intervention for Anxiety	Enhanced Usual Care
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	362	358
Measure Type: Number; Unit of Measure: infants
	79	68

3. Secondary Outcome

Title	Small-for-gestational Age Birth
Description	<10th% for gestational age at birth compared to the reference population
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Cognitive Behavioral Therapy Intervention for Anxiety	Enhanced Usual Care
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	362	358
Measure Type: Number; Unit of Measure: infants
	89	105

4. Secondary Outcome

Title	Low Birthweight
Description	weight of ≤2500 grams
Time Frame	at birth

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Cognitive Behavioral Therapy Intervention for Anxiety	Enhanced Usual Care
Arm/Group Description:	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.	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).
Overall Number of Participants Analyzed	362	358
Measure Type: Number; Unit of Measure: infants
	46	53

Adverse Events

Time Frame	5 months
Adverse Event Reporting Description	None of the participants died, only there were some neo-natal deaths which were reported as Severe Adverse Event.
Arm/Group Title	Cognitive Behavioral Therapy Intervention for Anxiety		Enhanced Usual Care
Arm/Group Description	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.		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).
All-Cause Mortality
	Cognitive Behavioral Therapy Intervention for Anxiety		Enhanced Usual Care
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/600 (0.00%)		0/600 (0.00%)
Serious Adverse Events
	Cognitive Behavioral Therapy Intervention for Anxiety		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	48/600 (8.00%)		42/600 (7.00%)
Injury, poisoning and procedural complications
Serious Adverse Event * [1]	48/600 (8.00%)	48	42/600 (7.00%)	42
* Indicates events were collected by non-systematic assessment; [1] Still birth, miscarriage and child deaths
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	0%
	Cognitive Behavioral Therapy Intervention for Anxiety		Enhanced Usual Care
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/600 (0.00%)		0/600 (0.00%)

Limitations and Caveats

The Covid-19 pandemic occurred in the middle of data collection for this study. Because of the lockdowns data collection was halted for a period and also slowed. It probably also contributed to loss to follow up as many women were fearful of coming to the hospital.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

• Name/Title: Pamela Surkan
• Organization: Johns Hopkins Bloomberg School of Public Health
• Phone: 4105027396
• EMail: psurkan@jhu.edu

Publications of Results:

Atif N, Nazir H, Zafar S, Chaudhri R, Atiq M, Mullany LC, Rowther AA, Malik A, Surkan PJ, Rahman A. Development of a Psychological Intervention to Address Anxiety During Pregnancy in a Low-Income Country. Front Psychiatry. 2020 Jan 10;10:927. doi: 10.3389/fpsyt.2019.00927. eCollection 2019.

Other Publications:

Surkan PJ, Hamdani SU, Huma ZE, Nazir H, Atif N, Rowther AA, Chaudhri R, Zafar S, Mullany LC, Malik A, Rahman A. Cognitive-behavioral therapy-based intervention to treat symptoms of anxiety in pregnancy in a prenatal clinic using non-specialist providers in Pakistan: design of a randomised trial. BMJ Open. 2020 Apr 15;10(4):e037590. doi: 10.1136/bmjopen-2020-037590.

Rowther AA, Kazi AK, Nazir H, Atiq M, Atif N, Rauf N, Malik A, Surkan PJ. "A Woman Is a Puppet." Women's Disempowerment and Prenatal Anxiety in Pakistan: A Qualitative Study of Sources, Mitigators, and Coping Strategies for Anxiety in Pregnancy. Int J Environ Res Public Health. 2020 Jul 8;17(14):4926. doi: 10.3390/ijerph17144926.

Rauf N, Zulfiqar S, Mumtaz S, Maryam H, Shoukat R, Malik A, Rowther AA, Rahman A, Surkan PJ, Atif N. The Impact of the COVID-19 Pandemic on Pregnant Women with Perinatal Anxiety Symptoms in Pakistan: A Qualitative Study. Int J Environ Res Public Health. 2021 Aug 4;18(16):8237. doi: 10.3390/ijerph18168237.

Kazi AK, Rowther AA, Atif N, Nazir H, Atiq M, Zulfiqar S, Malik A, Surkan PJ. Intersections between patient-provider communication and antenatal anxiety in a public healthcare setting in Pakistan. PLoS One. 2021 Feb 5;16(2):e0244671. doi: 10.1371/journal.pone.0244671. eCollection 2021.

Nazir H, Rowther AA, Rauf N, Atiq M, Kazi AK, Malik A, Atif N, Surkan PJ. 'Those whom I have to talk to, I can't talk to': Perceived social isolation in the context of anxiety symptoms among pregnant women in Pakistan. Health Soc Care Community. 2022 Nov;30(6):e5885-e5896. doi: 10.1111/hsc.14019. Epub 2022 Sep 19.

Zaidi A, Khan A, Rowther A, Nazir H, Perin J, Rauf N, Mumtaz S, Naseem H, Atif N, Rahman A, Surkan PJ, Malik A. Cultural adaptation and psychometric validation of the Pregnancy Experience Scale-Brief version (PES-Brief) in Pakistani women with antenatal anxiety symptoms. SSM Ment Health. 2022 Dec;2:100055. doi: 10.1016/j.ssmmh.2021.100055. Epub 2021 Dec 24.

Atif N, Rauf N, Nazir H, Maryam H, Mumtaz S, Zulfiqar S, Shouket R, Rowther AA, Malik A, Rahman A, Surkan PJ. Non-specialist-delivered psychosocial intervention for prenatal anxiety in a tertiary care setting in Pakistan: a qualitative process evaluation. BMJ Open. 2023 Feb 23;13(2):e069988. doi: 10.1136/bmjopen-2022-069988.

Malik A, Park S, Mumtaz S, Rowther A, Zulfiqar S, Perin J, Zaidi A, Atif N, Rahman A, Surkan PJ. Perceived Social Support and Women's Empowerment and Their Associations with Pregnancy Experiences in Anxious Women: A Study from Urban Pakistan. Matern Child Health J. 2023 May;27(5):916-925. doi: 10.1007/s10995-023-03588-6. Epub 2023 Feb 6.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Yonemoto N, Nagai S, Mori R. Schedules for home visits in the early postpartum period. Cochrane Database Syst Rev. 2021 Jul 21;7(7):CD009326. doi: 10.1002/14651858.CD009326.pub4.

• Responsible Party: Johns Hopkins Bloomberg School of Public Health
• ClinicalTrials.gov Identifier: NCT03880032
• Other Study ID Numbers: R01MH111859-01 ( U.S. NIH Grant/Contract )
• First Submitted: March 4, 2019
• First Posted: March 19, 2019
• Results First Submitted: December 21, 2023
• Results First Posted: February 15, 2024
• Last Update Posted: February 15, 2024