AnxietyHMHB-BioNCT04566861

Happy Mother - Healthy Baby: Supplement Study on Biological Processes Underlying Anxiety During Pregnancy

A study testing Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy in people with Anxiety, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Pakistan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

As a supplement to the ongoing randomized evaluation of the Cognitive Behavioral Therapy (CBT) anxiety prevention intervention in Pakistan (R01-MH111859), the investigators propose to explore potential biological mechanisms (related to inflammation and endocrine functioning) of antenatal anxiety through additional… Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Anxiety
What is being tested?: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 117 participants
Where: 1 sitePakistan
Study dates: 20 Oct 2020to 31 Aug 2022
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

ability to understand spoken Urdu
pregnant, ≤22 weeks' gestation
age ≥18 years
residence ≤20 km of Holy Family Hospital
intent to reside in the study areas until the completion of the study

Who cannot join

Current anemia
Current major depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation
Self-report of past or current significant learning disability
Self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug)
medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101)
ICU admission indicated by diagnosis (not only for assessment)

Trial locations and contacts

1 site in 1 country.

Pakistan1 site

Holy Family Hospital
Rawalpindi

Other trials in Pakistan

About this study

Official title: Biological Processes Underlying Anxiety During Pregnancy: A Substudy of an Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan

Read the detailed description

This study will leverage the ongoing randomized evaluation of the CBT anxiety prevention intervention in Pakistan (R01-MH111859) to explore potential biological mechanisms. This CBT intervention targets both sub-threshold anxiety symptoms and generalized anxiety disorder (GAD) in early- to mid- pregnancy, aiming to both prevent and treat Common Mental Disorders (CMDs) (GAD and major depressive episodes (MDE)) as well as improve birth outcomes. The study team proposes to additionally study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), the study will also include 100 healthy women without anxiety or depression. The aims are to 1) characterize the "immune phenotype" of anxious women across the peripartum, specifically by measuring the relation among anxiety symptoms and peripheral markers of inflammation within and across women (both anxious and healthy) and between those receiving the intervention and control; 2) determine the relation between levels of allopregnanolone (ALLO) in pregnancy and concurrent anxiety symptoms and future symptoms of postpartum depression (PPD), 3) examine the relation between changes in immune functioning and ALLO levels in anxious pregnancy across time, 4) examine whether immune function and/or ALLO are mediators or moderators of the association between antenatal anxiety and preterm birth and/or small-for-gestational age, and 5) examine the effects of both anxiety and the intervention (including biomarkers) on infant development at six weeks postpartum.

Conditions: Anxiety
Being tested: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy
Keywords: randomized controlled trial, inflammation, hormones
Medical subject headings: Anxiety Disorders, Inflammation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Cognitive Behavioral Therapy (CBT) for anxiety during pregnancyBehavioural
Women who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety.

Study groups in NCT04566861
Study group	Role	What they receive
Anxious pregnant women - intervention group	Experimental	100 pregnant women who have at least mild anxiety will be randomized to the intervention group where they will receive six one-on-one core sessions of Cognitive Behavioral Therapy during pregnancy (plus possible booster sessions) Receives: Behavioral: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy
Anxious pregnant women - enhanced usual care group	No intervention	100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the other group).
Non-anxious pregnant women - healthy control	No intervention	100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the other groups).

What is being measured

The primary outcome is the main question the study is designed to answer.

Peripheral Markers of Inflammation
Differences in levels of peripheral inflammatory markers and change in these markers across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious and healthy women, and between intervention and control women. Markers include IFNgamma, IL6, IL8, IL10, IL12p70, TNFalpha, IL17A, TARC, MIP1alpha, MCP4, Eotaxin
Measured: trimester 1, trimester 2, trimester 3, 6 weeks postpartum
Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
Measure differences in level of allopregnanolone (mean) at each time point and across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious women and healthy women, and between intervention and control.
The results are measured by log-transformed values of the concentration of each cytokine in the plasma, in ng/mL (nanogram per milliliter).
Measured: trimester 2, trimester 3, 6 weeks postpartum
Allopregnanolone Levels Predicting Postpartum Depression
Differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression (PPD).
The results are measured by log-transformed values of the concentration of allopregnanolone in the plasma, in ng/ml (nanogram per milliliter.
Women who have Allopregnanolone (ALLO) levels and developed PPD are analyzed.
Measured: Trimester 2
Allopregnanolone (ALLO) and Immune Function
Measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time (trimester 2 (T2), trimester 3 (T3) and 6 weeks postpartum (W6))
Measured: trimester 2, trimester 3, 6 weeks postpartum

Secondary outcomes (2)

Birth Outcomes
Differences in birth outcomes (preterm birth, small for gestational age, low birth weight) between women with high inflammatory markers vs. those low in inflammatory markers, and also between anxious and healthy women.
Measured: at birth
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
Measure infant neuro-development using Ages \& Stages Questionnaire to measure differences in infant neurodevelopment (communication, gross motor, fine motor, personal-social and problem solving) using a standardized questionnaire between those high in inflammatory markers vs. those low, and also between anxious and healthy women
communication cut-off score 22.77 gross motor cut-off score 41.84 fine motor cut-off score 30.16 personal-social cut-off score 24.62 problem solving cut-off score 33.71
Number of participants with impaired neuron-developmental infants (below cut-off scores) are reported below
Measured: 6 weeks postpartum

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 Oct 202031 Aug 2022

First posted28 Sep 2020
Study start20 Oct 2020
Primary completion31 Aug 2022
Study completion31 Aug 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (4)Papers the sponsor has linked to this study.
Other trials for AnxietyStudies of the same condition, open and under way.
More trials run by Johns Hopkins Bloomberg School of Public HealthThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Model description: Within women in a larger randomized trial (randomized to the intervention or enhanced care group), we propose to study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), we will also include 100 healthy women without anxiety or depression. These enrollment goals were modified after interruptions by the Covid-19 pandemic.
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 117 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04566861
Sponsor's protocol ID: 3R01MH111859-03S1
Other IDs: 3R01MH111859-03S1
Acronym: HMHB-Bio
Status last verified: Oct 2024
First submitted: 22 Sep 2020
Last updated: 20 Nov 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: De-identified project data from the study will be posted on ClinicalTrials.gov and the National Institute of Mental Health (NIMH) data archive.

Publications

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.
PubMed 31998151
Sherer ML, Malik A, Osborne LM, Rowther AA, Zaidi A, Atif N, Rahman A, Kahloon LE, Salman M, Yenokyan G, Surkan PJ. Biological Mechanisms in Pregnant Women With Anxiety (Happy Mother-Healthy Baby Supplement Study): Protocol for a Longitudinal Mixed Methods Observational Study. JMIR Res Protoc. 2023 Apr 11;12:e43193. doi: 10.2196/43193.
PubMed 37040167
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.
PubMed 32300002
Etyemez S, Mehta K, Tutino E, Zaidi A, Atif N, Rahman A, Malik A, Voegtline KM, Surkan PJ, Osborne LM. The immune phenotype of perinatal anxiety in an anxiety-focused behavioral intervention program in Pakistan. Brain Behav Immun. 2024 Aug;120:141-150. doi: 10.1016/j.bbi.2024.05.028. Epub 2024 May 21.
PubMed 38777289

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Anxiety trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Biological Processes Underlying Anxiety During Pregnancy: A Substudy of an Anxiety-focused Early Prenatal Intervention for the Prevention of Common Mental Disorders in Pakistan
ClinicalTrials.gov ID: NCT04566861
Acronym / sponsor ID: HMHB-Bio / 3R01MH111859-03S1
Conditions: Anxiety
Keywords: randomized controlled trial, inflammation, hormones
Study type: Interventional
Recruitment status: Completed
Enrolment: 117 participants (actual)
Lead sponsor: Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
Collaborators: Human Development Research Foundation, Pakistan, Rawalpindi Medical College, Pakistan, University of Liverpool, National Institute of Mental Health (NIMH)
Study start: 20 Oct 2020 (actual)
Primary completion: 31 Aug 2022 (actual)
Study completion: 31 Aug 2022 (actual)
First posted: 28 Sep 2020 (actual)
Results: Posted 20 Nov 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 3
Model description: Within women in a larger randomized trial (randomized to the intervention or enhanced care group), we propose to study biological correlates of antenatal anxiety (i.e., immune and endocrine functioning) in 300 women: in addition to 200 drawn from our randomized trial (100 intervention, 100 usual care), we will also include 100 healthy women without anxiety or depression. These enrollment goals were modified after interruptions by the Covid-19 pandemic.

Arm	Type	Receives
Anxious pregnant women - intervention group	Experimental	Behavioral: Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy100 pregnant women who have at least mild anxiety will be randomized to the intervention group where they will receive six one-on-one core sessions of Cognitive Behavioral Therapy during pregnancy (plus possible booster sessions)
Anxious pregnant women - enhanced usual care group	No intervention	–100 pregnant women who have at least mild anxiety will be randomized to the enhanced usual care group. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the other group).
Non-anxious pregnant women - healthy control	No intervention	–100 pregnant women who do not have symptoms of anxiety or depression be followed in the healthy control group. Reminder calls were given, provider visits were facilitated (shorter wait times), and transportation to assist participants in attending appointments and medically indicated ultrasounds were paid for (as in the other groups).

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

ability to understand spoken Urdu
pregnant, ≤22 weeks' gestation
age ≥18 years
residence ≤20 km of Holy Family Hospital
intent to reside in the study areas until the completion of the study

Key exclusion criteria (6 listed)

Current anemia
Current major depressive episode (MDE on SCID) or life-threatening health conditions including e.g. active severe depression or suicidal ideation
Self-report of past or current significant learning disability
Self-report of past or current psychiatric disorder (e.g. bipolar disorder or schizophrenia) or psychiatric care (e.g. current use of anxiolytic drug and/or other psychotropic drug)
medical disorders or severe maternal morbidity that require inpatient management that would preclude participation (101)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Cognitive Behavioral Therapy (CBT) for anxiety during pregnancyWomen who are randomized to the intervention group will receive six core Cognitive Behavioral Therapy (CBT) sessions for anxiety during pregnancy (and possible booster sessions) to treat symptoms of anxiety.	Behavioural	Anxious pregnant women - intervention group

Primary outcome

Peripheral Markers of Inflammation
Time frame: trimester 1, trimester 2, trimester 3, 6 weeks postpartum
Differences in levels of peripheral inflammatory markers and change in these markers across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious and healthy women, and between intervention and control women. Markers include IFNgamma, IL6, IL8, IL10, IL12p70, TNFalpha, IL17A, TARC, MIP1alpha, MCP4, Eotaxin
Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum
Time frame: trimester 2, trimester 3, 6 weeks postpartum
Measure differences in level of allopregnanolone (mean) at each time point and across time (trimester 1 (T1), trimester 2 (T2), trimester 3 (T3) and postpartum (PP)) between anxious women and healthy women, and between intervention and control. The results are measured by log-transformed values of the concentration of each cytokine in the plasma, in ng/mL (nanogram per milliliter).
Allopregnanolone Levels Predicting Postpartum Depression
Time frame: Trimester 2
Differences in allopregnanolone levels at the second trimester between women who do and do not go on to develop postpartum depression (PPD). The results are measured by log-transformed values of the concentration of allopregnanolone in the plasma, in ng/ml (nanogram per milliliter. Women who have Allopregnanolone (ALLO) levels and developed PPD are analyzed.
Allopregnanolone (ALLO) and Immune Function
Time frame: trimester 2, trimester 3, 6 weeks postpartum
Measure the relationship between ALLO levels and levels of peripheral inflammatory markers across time (trimester 2 (T2), trimester 3 (T3) and 6 weeks postpartum (W6))

2 secondary outcomes

Birth Outcomes
Time frame: at birth
Infant Neuro-development Using Ages & Stages Questionnaire, Third Edition (ASQ-3)
Time frame: 6 weeks postpartum

Results and safety

Results posted to the registry on 20 Nov 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Anxious Pregnant Women - Intervention Group	26	17
Anxious Pregnant Women - Enhanced Usual Care Group	31	19
Non-anxious Pregnant Women - Healthy Control	60	42

Primary outcome: Peripheral Markers of Inflammation

Time frame: trimester 1, trimester 2, trimester 3, 6 weeks postpartum. Mean (Standard Deviation). Unit: pg/ml

Measure	Anxious Pregnant Women - Intervention Group n = 26	Anxious Pregnant Women - Enhanced Usual Care Group n = 31	Non-anxious Pregnant Women - Healthy Control n = 60
TARC at T1	17.09 (10.30)	20.22 (10.85)	14.79 (8.06)
TARC at T2	11.78 (8.30)	12.12 (7.18)	11.65 (7.87)
TARC at T3	6.06 (2.95)	7.52 (3.29)	6.65 (3.35)
TARC at PP	15.28 (6.40)	18.07 (8.84)	16.81 (11.03)
MIP1alpha at T1	2.52 (1.61)	2.17 (0.75)	2.16 (0.74)
MIP1alpha at T2	4.09 (4.33)	2.93 (1.45)	3.41 (1.43)
MIP1alpha at T3	2.45 (0.99)	2.22 (0.60)	2.28 (1.02)
MIP1alpha at PP	3.62 (0.83)	3.23 (0.83)	3.54 (0.99)

Primary outcome: Allopregnanolone Levels and Anxiety Symptoms Across the Peripartum

Time frame: trimester 2, trimester 3, 6 weeks postpartum. Mean (Standard Deviation). Unit: log (ng/ml)

Measure	Anxious Pregnant Women - Intervention Group n = 21	Anxious Pregnant Women - Enhanced Usual Care Group n = 25	Non-anxious Pregnant Women - Healthy Control n = 50
Allopregnanolone at T2	-0.3796214 (0.7621596)	-0.3828328 (0.8335611)	-0.2820709 (0.9410302)
Allopregnanolone at T3	2.825177 (0.995552)	3.149545 (0.3715666)	3.048794 (0.3715666)
Allopregnanolone at W6	-0.592519 (0.5954829)	-0.6423627 (0.5764104)	-0.7948805 (0.4380674)

Population analysed: trimester 2, trimester 3, 6 weeks postpartum

Primary outcome: Allopregnanolone Levels Predicting Postpartum Depression

Time frame: Trimester 2. Mean (Standard Deviation). Unit: log (ng/ml)

Measure	Anxious Pregnant Women - Intervention Group n = 19	Anxious Pregnant Women - Enhanced Usual Care Group n = 21	Non-anxious Pregnant Women - Healthy Control n = 41
Allopregnanolone at T2 in women with PPD	-0.004127186 (0.7631303)	-0.8292861 (0.7694288)	–
Allopregnanolone at T2 in women without PPD	-0.4591347 (0.7616261)	-0.08843005 (0.7569726)	-0.1739193 (0.9115309)

Population analysed: Trimester 2. The numbers of analyzed data is lower than the overall number since not every women who had ALLO had also data available for PPD.

Primary outcome: Allopregnanolone (ALLO) and Immune Function

Time frame: trimester 2, trimester 3, 6 weeks postpartum. Number. Unit: p value

Measure	Anxious Pregnant Women - Intervention Group n = 21	Anxious Pregnant Women - Enhanced Usual Care Group n = 25	Non-anxious Pregnant Women - Healthy Control n = 50
T2 Allo and T2_EOTAXIN	0.607838873	0.508436643	0.731221724
T2 Allo and T2_IFNgam	0.943495625	0.962951805	0.32767424
T2 Allo and T2_IL10	0.442764509	0.852343415	0.251810201
T2 Allo and T2_IL12P70	0.043026211	0.182583506	0.032112919
T2 Allo and T2_IL17A	0.994071069	0.628278059	0.155033717
T2 Allo and T2_IL6	0.661240061	0.433900134	0.101928485
T2 Allo and T2_IL8	0.58507263	0.377422318	0.000902406
T2 Allo and T2_MCP4	0.253876939	0.975614712	0.261553

Population analysed: Trimester 2, 3, postpartum

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 5 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Anxious Pregnant Women - Intervention Group	9 of 26 (34.6%)	0 of 26 (0%)	0 of 26
Anxious Pregnant Women - Enhanced Usual Care Group	14 of 31 (45.2%)	0 of 31 (0%)	0 of 31
Non-anxious Pregnant Women - Healthy Control	20 of 60 (33.3%)	0 of 60 (0%)	0 of 60

Limitations and caveats (from the sponsor): The original sample size target was 300 for this biological supplement study. However, the study was delayed because of Covid-19 pandemic lockdowns in Pakistan and forced to end at the same time as the main study. This prevented us from collecting all the anticipated data, leaving us with a sample size of 117.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31998151Atif 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.
Background: PubMed 37040167Sherer ML, Malik A, Osborne LM, Rowther AA, Zaidi A, Atif N, Rahman A, Kahloon LE, Salman M, Yenokyan G, Surkan PJ. Biological Mechanisms in Pregnant Women With Anxiety (Happy Mother-Healthy Baby Supplement Study): Protocol for a Longitudinal Mixed Methods Observational Study. JMIR Res Protoc. 2023 Apr 11;12:e43193. doi: 10.2196/43193.
Results publication: PubMed 32300002Surkan 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.
Derived from this study: PubMed 38777289Etyemez S, Mehta K, Tutino E, Zaidi A, Atif N, Rahman A, Malik A, Voegtline KM, Surkan PJ, Osborne LM. The immune phenotype of perinatal anxiety in an anxiety-focused behavioral intervention program in Pakistan. Brain Behav Immun. 2024 Aug;120:141-150. doi: 10.1016/j.bbi.2024.05.028. Epub 2024 May 21.
Individual participant dataSharing planned: Yes. De-identified project data from the study will be posted on ClinicalTrials.gov and the National Institute of Mental Health (NIMH) data archive.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Pamela J Surkan, ScD principal investigator

Johns Hopkins Bloomberg School of Public Health

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive Behavioral Therapy (CBT) for anxiety during pregnancy in people with Anxiety, run by Johns Hopkins Bloomberg School of Public Health at 1 site in Pakistan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Peripheral Markers of Inflammation (time frame: trimester 1, trimester 2, trimester 3, 6 weeks postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04566861, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2024.