Kaimen Rigor reviewed

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Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.

Name: Kaimen Rigor review — Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.
Item: Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.
Rating: 100
Author: Alpha1

Surkan PJ, Malik A, Perin J, Atif N, Rowther A, Zaidi A, Rahman A

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Kaimen Rigor review — 3★ (Adequate), 0 critical, 0 high issues for “Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.”

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This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

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Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.

Surkan PJ, Malik A, Perin J, Atif N, Rowther A, Zaidi A, Rahman A

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DOI

10.1038/s41591-024-02809-x

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Kaimen Rigor reviewed

Rigor-Reviewed Manuscript

Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.

Surkan PJ, Malik A, Perin J, Atif N, Rowther A, Zaidi A, Rahman A

Paper source

Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.

Read full text (PMC)

Embed this Rigor badge

Links back to this Kaimen Rigor review.

Alpha1 Editorial

This rigor review was examined and confirmed by Alpha1 Editorial · August 16, 2026

Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×4−2★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit7 minor suggestions

This Kaimen Rigor review uses Kaimen Rigor reviewers trained on a curated corpus of high-fidelity and retracted papers, with expert supervision and curation. It can still make mistakes; verify each finding against the source before relying on it.

This is a well-conducted and well-reported phase 3 RCT with a strong scientific premise, rigorous design, and transparent reporting. The main weaknesses are minor reporting gaps: no explicit CONSORT reference, no explicit statistical assumption checks, and no analysis code sharing. The copyedit pass found only minor typos and rounding inconsistencies.

Both reviewers agreed on all dimensions and study type (interventional). The statistics verification recomputed 5 tests, all consistent; coverage is limited to tests with test statistics/df or effect estimates with CIs. The citation check found no retracted or unresolved references. The integrity check flagged only low-severity rounding differences, which are not validity threats.

Numerical inconsistencies

1 finding · worst low

Values that contradict each other or are impossible for the stated sample: recomputed p-values and test statistics, GRIM/GRIMMER checks on summary numbers, percentages against their own counts, totals against their parts, and estimates against their own confidence intervals.

Internal contradictions in the reported numbersAssessed

Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.

Overstated conclusions

None found

Conclusions that reach past what the paper's own results support — including a significance claim that no longer holds when the statistic is recomputed, and efficacy resting on an unvalidated surrogate endpoint.

Checked — nothing surfaced.

5 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

An adversarial read for patterns associated with data that may not be genuine: results that look too clean, implausibly large effects, duplicated data or images, and methods that do not match the results reported.

Checked — nothing surfaced.

Reporting gaps

None found

Required detail the manuscript never states — study design, biological variables, ethics approval and consent, key resources, statistical reporting, data and code availability, and overall transparency.

Checked — nothing surfaced.

Eight Dimensions8 pass

The introduction cites multiple studies on prevalence, co-occurrence, and consequences of prenatal anxiety, and notes the lack of preventive approaches. It also references the authors' own formative qualitative work that informed the intervention. The hypothesis follows logically from the cited evidence. Limitations of prior research (e.g., focus on depression, not anxiety) are explicitly addressed.

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper establishes a strong scientific premise by citing prior research on prenatal anxiety as a predictor of postnatal CMDs, the treatment gap in LMICs, and the lack of preventive interventions, and it builds a logical rationale for the study.

Evidence

“Prenatal anxiety predicts anxiety, depression and suicide risk in the postnatal period”

Introduction ¶1Find in source

“Effective treatments exist, but preventive approaches that could reduce the prevalence of severe postnatal depression are lacking”

Introduction ¶3Find in source

“much less attention has been paid to maternal anxiety and stress than depression”

Discussion ¶2Find in source

PASSReviewer 2· 90% conf

Evidence

“Prenatal anxiety predicts anxiety, depression and suicide risk in the postnatal period”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 3]

“Effective treatments exist, but preventive approaches that could reduce the prevalence of severe postnatal depression are lacking.”

“According to a systematic review, much less attention has been paid to maternal anxiety and stress than depression, and even fewer studies have tested the effects of prenatal interventions on postnatal anxiety”

Discussion ¶2Find in source

Randomization used a pseudo random-number generator with permuted blocks of sizes 4, 8, 12, 16, and allocation concealment via opaque envelopes. The unit of randomization is the individual woman. Outcome assessors were blinded to allocation. A power calculation assumed 30% CMD prevalence, 30% reduction, 85% power, and 30% attrition, targeting 1200 women. Inclusion/exclusion criteria are detailed. The primary analysis is ITT; missing data were handled by complete-case analysis, and Little's MCAR test was used to assess missingness. No separate replication cohort is reported, but this is not expected for a single pivotal trial.

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The trial design is rigorous: randomization method and unit are described, blinding of outcome assessors is stated, a power calculation is provided, inclusion/exclusion criteria are pre-specified, and the analysis population (ITT) is defined.

Evidence

“Arm assignment was generated using a pseudo random-number generator by a trial statistician in the US based on randomly permuted blocks of size 4, 8, 12 and 16.”

MethodsFind in source

“Outcome assessors were blinded to the trial arm allocation.”

MethodsFind in source

“we calculated needing 840 pregnant women (420 in each arm) to achieve 85% power to detectable a 30% reduction in CMDs”

MethodsFind in source

PASSReviewer 2· 95% conf

Evidence

“Arm assignment was generated using a pseudo random-number generator by a trial statistician in the US based on randomly permuted blocks of size 4, 8, 12 and 16.”

MethodsFind in source

“Outcome assessors were blinded to the trial arm allocation.”

MethodsFind in source

“Assuming this prevalence, we calculated needing 840 pregnant women (420 in each arm) to achieve 85% power to detectable a 30% reduction in CMDs (30% in the control arm compared to 21% in the intervention arm).”

MethodsFind in source

Sex is inherently female (pregnant women), and both arms include women, so sex_justified is not applicable. Age, gestational age, and health status (anxiety/depression scores) are reported in Table 1. Demographics such as education, income, and family structure are also reported. Species/strain and housing conditions are not applicable for a human trial.

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study reports key demographic and clinical characteristics of participants, including age, gestational age, and baseline anxiety/depression scores, and compares arms at baseline.

Evidence

“Participants had an average age of 25 (standard deviation (SD) 4.7) years at enrollment, with an average gestational age of 16 (SD=5) weeks.”

ResultsFind in source

“Participants had at least mild anxiety at enrollment by design, with an average Hospital Anxiety and Depression Scale (HADS) anxiety score of 11.0 (SD=2.0).”

ResultsFind in source

paraphrase[Table 1]

“Table 1 lists education level and monthly income categories with counts and percentages.”

PASSReviewer 2· 90% conf

The study reports key demographic and clinical characteristics of participants, including age, gestational age, anxiety/depression scores, and other relevant variables. Sex is not applicable as all participants are female by design.

Evidence

“Participants had an average age of 25 (standard deviation (SD) 4.7) years at enrollment, with an average gestational age of 16 (SD=5) weeks.”

ResultsFind in source

“Table 1. Description of 1200 pregnant women enrolled in the HMHB trial by arm.”

Table 1Find in source

Ethical approval was obtained from three named IRBs (Rawalpindi Medical University, Human Development Research Foundation, Johns Hopkins Bloomberg School of Public Health) with protocol numbers, and an NIMH-appointed DSMB. Written informed consent was obtained from all participants. The trial was registered at ClinicalTrials.gov. Regulatory compliance is implied through IRB approvals and DSMB oversight.

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports named IRB approvals with protocol numbers, written informed consent, and compliance with relevant regulations, including DSMB oversight.

Evidence

“Ethical approval for this research was obtained from the Institutional Review Boards of Rawalpindi Medical University, Human Development Research Foundation, and the Johns Hopkins Bloomberg School of Public Health and an NIMH-appointed Data Safety Monitoring Board.”

EthicsFind in source

“All participants provided written informed consent prior to screening and to data collection.”

EthicsFind in source

paraphrase[Methods, Ethical Approval]

“The trial was registered at the US National Library of Medicine ( clinicaltrials.gov : NCT03880032 )”

PASSReviewer 2· 95% conf

The study reports ethical approval from named IRBs and informed consent, and it is registered on ClinicalTrials.gov.

Evidence

EthicsFind in source

“All participants provided written informed consent prior to screening and to data collection.”

EthicsFind in source

“clinicaltrials.gov (http://clinicaltrials.gov) #: NCT03880032”

AbstractFind in source

The HMHB intervention is described in detail (six core sessions, booster sessions, content based on CBT and THP). The control condition (enhanced routine care) is also described. The paper identifies the software used for data collection (Open Data Kit) and statistical analysis (R 4.2.0). No antibodies, cell lines, or other bench reagents are used, so those criteria are not applicable.

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (HMHB intervention) is described in detail, and the software used for data collection and analysis is identified.

Evidence

paraphrase[Methods, The HMHB intervention]

“The treatment arm Women in the treatment arm received six core sessions and were allowed up to 6 supplemental booster sessions of HMHB, a psychosocial intervention based on CBT for expectant women experiencing anxiety during early to mid-pregnancy.”

“Statistical analyses were performed with R 4.2.0.”

Statistical analysisFind in source

“The Open Data Kit (ODK) was used to store data in a de-identified format.”

MethodsFind in source

PASSReviewer 2· 85% conf

The investigational product (HMHB intervention) is described in detail, and the software used for data collection (ODK) and analysis (R) are identified. No antibodies, cell lines, or other bench reagents are used.

Evidence

“The HMHB intervention While the intervention content was informed by formative qualitative research – , it uses the same core principles and strategies of the Thinking Healthy Program (THP), an evidence-based psychosocial intervention for mothers experiencing perinatal depression .”

MethodsFind in source

“Statistical analyses were performed with R 4.2.0.”

Statistical analysisFind in source

The paper names logistic and linear regression, Student's t-test, and Chi-square test. Effect sizes (ORs and mean differences) are reported with 95% CIs. Exact p-values are given for primary outcomes (e.g., p = 7.0 ×10^-11). Assumptions are not explicitly tested, but the use of standard methods for large samples is acceptable. Data presentation includes tables with per-group Ns and dispersion. Mathematical plausibility checks were not performed due to lack of raw data, but no obvious inconsistencies were noted.

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Statistical tests are named, effect sizes with confidence intervals are reported, software is identified, and data presentation is appropriate for a clinical trial. Exact p-values are reported for primary outcomes.

Evidence

“we performed standard statistical comparisons such as the Student’s t-test and the Chi-square test”

Statistical analysisFind in source

“aOR=0.19, 95% CI: 0.14-0.28”

ResultsFind in source

“p | 7.0 ×10^E-11”

Table 4Find in source

PASSReviewer 2· 90% conf

Statistical methods are appropriate and well-described: tests are named, effect sizes with confidence intervals are reported, software is identified, and data presentation follows clinical trial conventions. Exact p-values are reported for primary outcomes.

Evidence

“we performed standard statistical comparisons such as the Student’s t-test and the Chi-square test, depending on the type of variable.”

Statistical analysisFind in source

“aOR=0.19, 95% CI: 0.14-0.28”

ResultsFind in source

“p | 7.0 ×10^E-11 | 2.8 ×10^E-20 | 1.7 ×10^E-22”

Table 4Find in source

The data availability statement names the NIMH Data Archive (nda.nih.gov) as the repository, which is a concrete access route. The paper also mentions that data structures and codebooks are uploaded there. No custom code is mentioned, so code_sharing is not applicable. Repository deposit and accession numbers are not applicable for patient-level data, but the NIMH Data Archive provides a managed access mechanism.

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper provides a data availability statement with a concrete route (NIMH Data Archive) and states that codebooks are available.

Evidence

“All our data and relevant codebooks have been submitted to the US National Institute of Mental Health’s data archive for public access, which can be accessed at https://nda.nih.gov/ .”

Data availabilityFind in source

“Data structures, variables and variables names and relevant codebooks used for the statistical analyses have been uploaded to the NIMH Data Archives and are freely available to the public for use https://nda.nih.gov/ .”

Data availabilityFind in source

PASSReviewer 2· 90% conf

The paper provides a data availability statement with a concrete route to access data via the NIMH Data Archive, and codebooks are also available. No code is shared, but the analysis is standard and code sharing is not explicitly required.

Evidence

“All our data and relevant codebooks have been submitted to the US National Institute of Mental Health’s data archive for public access, which can be accessed at https://nda.nih.gov/ .”

Data availabilityFind in source

Methods are detailed enough for replication. The trial is registered (NCT03880032). Limitations are discussed extensively, including loss to follow-up and COVID-19 impact. Conclusions are proportional to the evidence. Funding (NIMH grant) and COI (none declared) are stated. No reporting guideline (e.g., CONSORT) is explicitly mentioned, but the paper follows standard trial reporting.

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper reports methods in detail, is registered, discusses limitations, and provides funding and COI statements. It does not explicitly reference a reporting guideline, but the trial is registered and outcomes are reported.

Evidence

paraphrase[Methods, Ethical Approval]

“The trial was registered at the US National Library of Medicine ( clinicaltrials.gov : NCT03880032 )”

“One limitation to our intervention was loss to follow-up.”

Discussion ¶5Find in source

“This study was supported by the National Institute of Mental Health at the US National Institutes of Health Grant # RO1 MH111859”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

The paper is transparent: methods are detailed, the trial is registered, limitations are discussed, conclusions are proportional, and funding and competing interests are declared. A reporting guideline is not explicitly mentioned, but the paper follows CONSORT-like structure.

Evidence

“The trial was registered at the US National Library of Medicine ( clinicaltrials.gov (http://clinicaltrials.gov) : NCT03880032”

EthicsFind in source

“One limitation to our intervention was loss to follow-up.”

Discussion ¶6Find in source

“This study was supported by the National Institute of Mental Health at the US National Institutes of Health Grant # RO1 MH111859”

AcknowledgementsFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 72 references by DOI: 62 verified — 10 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

7 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

The published work is robust and well-reported. An informed reader should weigh the minor reporting gaps (no explicit CONSORT reference, no explicit assumption checks, no code sharing) as transparency limitations, but none undermine the validity of the findings. No erratum or correction is warranted based on the identified issues.

1.
MEDIUMreporting
Add an explicit statement referencing the CONSORT reporting guideline in the Methods or a separate section.
Enhances transparency and aligns with standard trial reporting expectations.
2.
MEDIUMstatistics
Add a statement about verifying statistical assumptions (e.g., normality, homoscedasticity) for linear regression models, or justify why they are not needed, in the Statistical analyses section.
Reviewer 2 flagged this as a reporting gap; explicit assumption checks strengthen the statistical analysis.
3.
MEDIUMdata code
Consider sharing the analysis code in a public repository (e.g., GitHub) to facilitate reproducibility.
Even though data are available, code sharing would improve reproducibility and is a common reviewer request.
4.
MEDIUMreporting
Clarify the handling of missing data for secondary outcomes and sensitivity analyses in the Statistical analyses section.
The paper uses complete-case analysis; specifying sensitivity analyses would address potential bias from missing data.
5.
MEDIUMreporting
Provide a more detailed description of the randomization sequence generation and allocation concealment in the Methods to fully meet CONSORT requirements.
Reviewer 2 suggested this to fully meet CONSORT requirements.
6.
MEDIUMreporting
Include a statement on whether any deviations from the pre-specified statistical analysis plan occurred, beyond those already mentioned.
Transparency about protocol deviations is important for trial reporting.
7.
MEDIUMreporting
Consider reporting the number of participants who received each number of booster sessions to better describe intervention dose.
Provides a clearer picture of intervention adherence and dose-response.
8.
MEDIUMreporting
Add a note on the generalizability of the findings given the high attrition rate and the COVID-19 pandemic context.
Contextualizes the results and helps readers interpret external validity.
9.
LOWcopyedit
Fix the typo in the Methods, Power calculation: change 'to detectable' to 'to detect'.
Grammatical error that should be corrected.
10.
LOWcopyedit
Remove the stray 'N' at the beginning of the sentence in the Abstract: 'NGiven many women are required...'.
Typographical error that should be corrected.
11.
LOWcopyedit
Use standard scientific notation in Table 4 (e.g., 7.0 × 10^-11) instead of '7.0 ×10^E-11'.
Formatting issue that could confuse readers.
12.
LOWcopyedit
Specify the significance level (e.g., alpha = 0.05) in the Statistical analyses section where it says 'P-values were two-sided'.
Minor omission that clarifies the threshold for significance.
13.
LOWcopyedit
Ensure percentages in the text (e.g., '12%' and '41%') are consistent with Table 4 (11.6% and 40.5%) or clarify that they are rounded.
Rounding differences are acceptable but should be noted for consistency.
14.
LOWreporting
Consider reporting the number of participants who received the intervention as randomized (per-protocol) in addition to ITT.
Addresses the 25% who never received any session and provides a sensitivity analysis.
15.
LOWreporting
Clarify the definition of 'enhanced routine care' to specify what constitutes 'enhanced' beyond the listed components.
Improves clarity of the control condition.

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Read alongside

Anxiety-focused cognitive behavioral therapy delivered by non-specialists to prevent postnatal depression: a randomized, phase 3 trial.

Surkan PJ, Malik A, Perin J, Atif N, Rowther A, Zaidi A, Rahman A

Read full text (PMC)

DOI

10.1038/s41591-024-02809-x

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Record fingerprint

c9f4bfe855cc31fa2d253b8ba6003b8e8cee41f0793bc6e5daf764c89374bb78

Verify via API

Issued Aug 16, 2026Engine 7.39.0

Alpha1 assesses methodological rigor, not the importance of the findings. See how we calibrate →

Kaimen Rigor review

Kaimen Rigor reviewed

3 / 5

Adequate — real issues to address

Interventional Study

Critical

High-priority

How this rating was calculated▸

Started at 5★ — deductions

IntegrityIntegrity concern ×4−2★

Model-reported confidence: highReviewer agreement: highEngine: 7.39.0Source: full text

Findings by category

101ArithmeticNumerical inconsistencies 02OverreachNone found 03AuthenticityNone found 04DisclosureNone found 05AvailabilityNone found 06Copyedit7 minor suggestions

Numerical inconsistencies

1 finding · worst low

Internal contradictions in the reported numbersAssessed

Recomputed 5 tests: 5 consistent, 0 inconsistent; 5 via agent-written checks.

Overstated conclusions

None found

Checked — nothing surfaced.

5 major claims checked against the paper's own evidence: all adequately supported.

Efficacy claim is anchored to an adequate endpoint and a meaningful effect.

Data authenticity concerns

None found

Checked — nothing surfaced.

Reporting gaps

None found

Checked — nothing surfaced.

Eight Dimensions8 pass

Sub-criteria

prior work citedADEQUATE

premise rationaleADEQUATE

limitations addressedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“Prenatal anxiety predicts anxiety, depression and suicide risk in the postnatal period”

Introduction ¶1Find in source

“Effective treatments exist, but preventive approaches that could reduce the prevalence of severe postnatal depression are lacking”

Introduction ¶3Find in source

“much less attention has been paid to maternal anxiety and stress than depression”

Discussion ¶2Find in source

PASSReviewer 2· 90% conf

Evidence

“Prenatal anxiety predicts anxiety, depression and suicide risk in the postnatal period”

Introduction ¶1Find in source

paraphrase[Introduction, paragraph 3]

“Effective treatments exist, but preventive approaches that could reduce the prevalence of severe postnatal depression are lacking.”

Discussion ¶2Find in source

Sub-criteria

controlsN/A

power analysisADEQUATE

blinding levelsADEQUATE

outlier handlingADEQUATE

randomization unitADEQUATE

inclusion exclusionADEQUATE

randomization methodADEQUATE

replicate distinctionN/A

independent replicationN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

Evidence

“Arm assignment was generated using a pseudo random-number generator by a trial statistician in the US based on randomly permuted blocks of size 4, 8, 12 and 16.”

MethodsFind in source

“Outcome assessors were blinded to the trial arm allocation.”

MethodsFind in source

“we calculated needing 840 pregnant women (420 in each arm) to achieve 85% power to detectable a 30% reduction in CMDs”

MethodsFind in source

PASSReviewer 2· 95% conf

Evidence

“Arm assignment was generated using a pseudo random-number generator by a trial statistician in the US based on randomly permuted blocks of size 4, 8, 12 and 16.”

MethodsFind in source

“Outcome assessors were blinded to the trial arm allocation.”

MethodsFind in source

Sub-criteria

demographicsADEQUATE

sex reportedADEQUATE

sex justifiedN/A

age weight healthADEQUATE

housing conditionsN/A

species strain sourceN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The study reports key demographic and clinical characteristics of participants, including age, gestational age, and baseline anxiety/depression scores, and compares arms at baseline.

Evidence

“Participants had an average age of 25 (standard deviation (SD) 4.7) years at enrollment, with an average gestational age of 16 (SD=5) weeks.”

ResultsFind in source

“Participants had at least mild anxiety at enrollment by design, with an average Hospital Anxiety and Depression Scale (HADS) anxiety score of 11.0 (SD=2.0).”

ResultsFind in source

paraphrase[Table 1]

“Table 1 lists education level and monthly income categories with counts and percentages.”

PASSReviewer 2· 90% conf

Evidence

“Participants had an average age of 25 (standard deviation (SD) 4.7) years at enrollment, with an average gestational age of 16 (SD=5) weeks.”

ResultsFind in source

“Table 1. Description of 1200 pregnant women enrolled in the HMHB trial by arm.”

Table 1Find in source

Sub-criteria

iacuc statementN/A

informed consentADEQUATE

irb ethics statementADEQUATE

regulatory complianceADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 95% conf

The study reports named IRB approvals with protocol numbers, written informed consent, and compliance with relevant regulations, including DSMB oversight.

Evidence

EthicsFind in source

“All participants provided written informed consent prior to screening and to data collection.”

EthicsFind in source

paraphrase[Methods, Ethical Approval]

“The trial was registered at the US National Library of Medicine ( clinicaltrials.gov : NCT03880032 )”

PASSReviewer 2· 95% conf

The study reports ethical approval from named IRBs and informed consent, and it is registered on ClinicalTrials.gov.

Evidence

EthicsFind in source

“All participants provided written informed consent prior to screening and to data collection.”

EthicsFind in source

“clinicaltrials.gov (http://clinicaltrials.gov) #: NCT03880032”

AbstractFind in source

Sub-criteria

mycoplasma testingN/A

reagents identifiedADEQUATE

organisms identifiedN/A

antibodies identifiedN/A

cell line authenticationN/A

software tools identifiedADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The investigational product (HMHB intervention) is described in detail, and the software used for data collection and analysis is identified.

Evidence

paraphrase[Methods, The HMHB intervention]

“Statistical analyses were performed with R 4.2.0.”

Statistical analysisFind in source

“The Open Data Kit (ODK) was used to store data in a de-identified format.”

MethodsFind in source

PASSReviewer 2· 85% conf

Evidence

MethodsFind in source

“Statistical analyses were performed with R 4.2.0.”

Statistical analysisFind in source

Sub-criteria

tests namedADEQUATE

exact p valuesADEQUATE

effect sizes ciADEQUATE

data presentationADEQUATE

software identifiedADEQUATE

assumptions verifiedADEQUATE

mathematical plausibilityN/A

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

“we performed standard statistical comparisons such as the Student’s t-test and the Chi-square test”

Statistical analysisFind in source

“aOR=0.19, 95% CI: 0.14-0.28”

ResultsFind in source

“p | 7.0 ×10^E-11”

Table 4Find in source

PASSReviewer 2· 90% conf

Evidence

“we performed standard statistical comparisons such as the Student’s t-test and the Chi-square test, depending on the type of variable.”

Statistical analysisFind in source

“aOR=0.19, 95% CI: 0.14-0.28”

ResultsFind in source

“p | 7.0 ×10^E-11 | 2.8 ×10^E-20 | 1.7 ×10^E-22”

Table 4Find in source

Sub-criteria

code sharingN/A

accession numbersN/A

repository depositADEQUATE

data availability statementADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

The paper provides a data availability statement with a concrete route (NIMH Data Archive) and states that codebooks are available.

Evidence

“All our data and relevant codebooks have been submitted to the US National Institute of Mental Health’s data archive for public access, which can be accessed at https://nda.nih.gov/ .”

Data availabilityFind in source

PASSReviewer 2· 90% conf

Evidence

“All our data and relevant codebooks have been submitted to the US National Institute of Mental Health’s data archive for public access, which can be accessed at https://nda.nih.gov/ .”

Data availabilityFind in source

Sub-criteria

funding coiADEQUATE

trial registrationADEQUATE

reporting guidelineNOT REPORTED

methods completenessADEQUATE

all outcomes reportedADEQUATE

limitations discussedADEQUATE

conclusions proportionalADEQUATE

Per reviewer (2) — the votes behind the verdict

PASSReviewer 1· 90% conf

Evidence

paraphrase[Methods, Ethical Approval]

“The trial was registered at the US National Library of Medicine ( clinicaltrials.gov : NCT03880032 )”

“One limitation to our intervention was loss to follow-up.”

Discussion ¶5Find in source

“This study was supported by the National Institute of Mental Health at the US National Institutes of Health Grant # RO1 MH111859”

AcknowledgementsFind in source

PASSReviewer 2· 90% conf

Evidence

“The trial was registered at the US National Library of Medicine ( clinicaltrials.gov (http://clinicaltrials.gov) : NCT03880032”

EthicsFind in source

“One limitation to our intervention was loss to follow-up.”

Discussion ¶6Find in source

“This study was supported by the National Institute of Mental Health at the US National Institutes of Health Grant # RO1 MH111859”

AcknowledgementsFind in source

Registered (1 ID: ClinicalTrials.gov). No reporting guideline cited.

Broken references and links

None found

References checked against Crossref, OpenAlex and Retraction Watch for retractions and resolvability, plus declared data and code links probed for whether they resolve to content matching the paper.

Checked — nothing surfaced.

Checked 72 references by DOI: 62 verified — 10 no DOI (shown, not verified).

1 data/code link checked; 1 live.

Copyediting

7 minor

Wording, consistency and formatting errors that need correcting before submission.

No major wording or formatting errors. 7 minor suggestions below.

7 copyedit issues flagged: mostly typo, consistency, clarity.

Kaimen Rigor Action ItemsFinal pass before journal submission

1.
MEDIUMreporting
Add an explicit statement referencing the CONSORT reporting guideline in the Methods or a separate section.
Enhances transparency and aligns with standard trial reporting expectations.
2.
MEDIUMstatistics
Add a statement about verifying statistical assumptions (e.g., normality, homoscedasticity) for linear regression models, or justify why they are not needed, in the Statistical analyses section.
Reviewer 2 flagged this as a reporting gap; explicit assumption checks strengthen the statistical analysis.
3.
MEDIUMdata code
Consider sharing the analysis code in a public repository (e.g., GitHub) to facilitate reproducibility.
Even though data are available, code sharing would improve reproducibility and is a common reviewer request.
4.
MEDIUMreporting
Clarify the handling of missing data for secondary outcomes and sensitivity analyses in the Statistical analyses section.
The paper uses complete-case analysis; specifying sensitivity analyses would address potential bias from missing data.
5.
MEDIUMreporting
Provide a more detailed description of the randomization sequence generation and allocation concealment in the Methods to fully meet CONSORT requirements.
Reviewer 2 suggested this to fully meet CONSORT requirements.
6.
MEDIUMreporting
Include a statement on whether any deviations from the pre-specified statistical analysis plan occurred, beyond those already mentioned.
Transparency about protocol deviations is important for trial reporting.
7.
MEDIUMreporting
Consider reporting the number of participants who received each number of booster sessions to better describe intervention dose.
Provides a clearer picture of intervention adherence and dose-response.
8.
MEDIUMreporting
Add a note on the generalizability of the findings given the high attrition rate and the COVID-19 pandemic context.
Contextualizes the results and helps readers interpret external validity.
9.
LOWcopyedit
Fix the typo in the Methods, Power calculation: change 'to detectable' to 'to detect'.
Grammatical error that should be corrected.
10.
LOWcopyedit
Remove the stray 'N' at the beginning of the sentence in the Abstract: 'NGiven many women are required...'.
Typographical error that should be corrected.
11.
LOWcopyedit
Use standard scientific notation in Table 4 (e.g., 7.0 × 10^-11) instead of '7.0 ×10^E-11'.
Formatting issue that could confuse readers.
12.
LOWcopyedit
Specify the significance level (e.g., alpha = 0.05) in the Statistical analyses section where it says 'P-values were two-sided'.
Minor omission that clarifies the threshold for significance.
13.
LOWcopyedit
Ensure percentages in the text (e.g., '12%' and '41%') are consistent with Table 4 (11.6% and 40.5%) or clarify that they are rounded.
Rounding differences are acceptable but should be noted for consistency.
14.
LOWreporting
Consider reporting the number of participants who received the intervention as randomized (per-protocol) in addition to ITT.
Addresses the 25% who never received any session and provides a sensitivity analysis.
15.
LOWreporting
Clarify the definition of 'enhanced routine care' to specify what constitutes 'enhanced' beyond the listed components.
Improves clarity of the control condition.

Full text (66,577 chars)Analyzed: Aug 16, 2026