NCT07159516

Brief Summary

A total of 67 people were recruited from maternity units and social media to take part in the study. They first completed an online questionnaire, then filled out the CityBiTS measure, and finally took part in a diagnostic interview over the phone. The CityBiTS scores were compared to the results of the interviews using ROC curve analysis. We looked at how well the scores identified cases (sensitivity), correctly identified non-cases (specificity), and overall accuracy to find the best cutoff scores and see how these compared to other available methods.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2025

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 8, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2025

Enrollment Period

1 year

First QC Date

August 21, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

PTSDchildbirthcut-offCityBitssensitivityspecificityDiagnostic InterviewROC curve

Outcome Measures

Primary Outcomes (1)

  • Number of participants fulfilling the diagnostic criteria for BR-PTSD based on the diagnostic interview compared to CityBiTS

    Day 1

Secondary Outcomes (1)

  • Cut-offs for CityBits

    up to 6 months

Study Arms (1)

Individuals recruited from birth units and social media who recently gave birth

Diagnostic Test: Diagnostic interview

Interventions

Diagnostic interviewDIAGNOSTIC_TEST

SCID-5 Clinician Version (SCID-5-CV) was used as gold standard method for determining if diagnostic criteria of PTSD was met or not (First, 2023). SCID-5-CV has been validated for use via telephone with good results for PTSD (Osorio et al., 2019). Only the PTSD-chapter was used, and exclusively birth-related traumatic experiences were considered. This was done achieved by adding a question to the interview guide, addressing potentially traumatic experiences associated with healthcare during a physical examination, operation, intensive care or childbirth.

Individuals recruited from birth units and social media who recently gave birth

Eligibility Criteria

Age18 Years+
Sexfemale
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Recruitment was performed from a risk group of individuals with a higher likelihood of having BR-PTSD than the average population, to decrease the number of needed diagnostic interviews. Recruitment was made achieved via two different paths. Since birth complications are important risk factors for BR-PTSD, individuals with documented medical complications during birth were recruited from nine birth units in different parts of Sweden for the first path. These were identified by the following diagnostic codes in medical records. Those meeting inclusion criteria were invited by postal mail, including information about the study as well as a link and QR-code to the first survey. The second recruitment path was via social media. The ad invited those who had recently given birth and experienced the birth as difficult.

You may qualify if:

  • age 18 or more
  • who had given birth with a minimum at four weeks prior to completing CityBiTS,
  • who had a sufficient level of Swedish to participate.

You may not qualify if:

  • Cases of stillbirth

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vrinnevisjukhuset, KK

Norrköping, 603 54, Sweden

Location

MeSH Terms

Conditions

Stress Disorders, Post-TraumaticCombat DisordersHypersensitivity

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental DisordersImmune System Diseases

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Associate Professor

Study Record Dates

First Submitted

August 21, 2025

First Posted

September 8, 2025

Study Start

November 1, 2023

Primary Completion

November 1, 2024

Study Completion

November 1, 2024

Last Updated

September 8, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations