NCT07110727

Brief Summary

This is a community- and hospital-based interventional study consisting of two interventions:

  • Capacity building of healthcare workers (HCWs) in the intervention group (Buea Regional Hospital, selected by simple random sampling-balloting method) on management of post-traumatic stress disorder (PTSD) among road traffic injury (RTI) patients (victims). This intervention will be evaluated using pre/posttest scores via a questionnaire to be administered to HCWs to assess change in knowledge and comfort level in PTSD management and 6 months of follow-up to assess change in practice (number of RTI patients screened for PTSD and number of identified PTSD cases referred for treatment to mental health specialists) after the capacity building.
  • Also, a pre/post quasi-experimental study design without a control group where psychotherapy will be used in a 6-month follow-up of RTI patients diagnosed with PTSD. The participants (RTI patients diagnosed with PTSD) that will be used for this pre/post quasi-experimental study using psychotherapy will come from the baseline study where the prevalence of PTSD among RTI victims will be determined. The goal of this clinical trial is to learn if capacity building of healthcare workers on the management (screening, treatment, and referral) of post-traumatic stress disorder (PTSD) among road traffic injury (RTI) patients in hospitals leads to change in knowledge and comfort level of healthcare workers in screening and timely management of PTSD to improve patients' outcomes. Given that attention to care for RTI victims in hospitals in Cameroon and Fako Division in particular is focused on physical care, this study seeks to ensure the provision of holistic care to RTI victims in hospitals, which is in line with the definition of health (comprising the mental, physical, and social well-being of individuals and not just the mere absence of disease or infirmity) by the World Health Organization (WHO). This study will also, through the pre/post quasi-experiment without a control group, learn about the feasibility of using/integrating psychotherapy alongside timely screening for PTSD in routine RTI patient care in primary health care to improve PTSD status in adult RTI patients diagnosed with PTSD in the Cameroonian context. This study aims to answer five research questions: Research Questions
  • What is the epidemiological profile of RTI patients at health facilities in Fako Division from 2019 to 2023?
  • What is the prevalence of PTSD among RTI patients in health facilities in Fako Division?
  • What factors are associated with PTSD among RTI patients in health facilities in Fako Division?
  • What is the standard of PTSD care provided to RTI patients in health facilities in Fako Division?
  • What is the impact of capacity building of healthcare workers on the management of PTSD in RTI patients in health facilities in Fako Division? Researchers will
  • Describe the epidemiological profile of RTI patients in hospitals in Fako Division, Cameroon, from January 2019 to December 2023, particularly with regard to PTSD screening recommendation and uptake via an exhaustive chart review of medical records.
  • Determine the prevalence of PTSD among RTI patients via survey using PCL-5 and a cut-off score of at least 33/80.
  • Assess factors associated with PTSD.
  • Assess care given to RTI patients and identify barriers, particularly regarding PTSD management.
  • Compare pre/posttest scores (at baseline-T0, post-training-T1, and 30 days post-training-T2) of healthcare workers' knowledge and comfort level in PTSD management following capacity building of HCWs on PTSD management to see if there is change in knowledge and comfort level due to the capacity-building intervention in the randomly selected hospital chosen as the intervention group (Buea Regional Hospital) and also establish if the knowledge was sustained after 30 days.
  • Collect data at 1, 3, and 6 months of follow-up on the number of RTI patients screened for PTSD by trained health workers during 6 months of post-training follow-up and the number of timely referrals of PTSD cases identified, and compare these to what was obtained before the training (baseline) and establish if there is a change.
  • Collect data on the PTSD status of PTSD patients at 1, 3, and 6 months of follow-up with psychotherapy and conclude on the feasibility of including psychotherapy in the Cameroonian context to improve PTSD status. Participants (RTI victims) will:
  • Be booked for PTSD screening 1 month after RTI, be called up for an appointment to be screened 1 month after RTI, and have diagnosed PTSD cases referred for effective management.
  • Diagnosed PTSD cases will be followed up with psychotherapy once every 2 weeks for 6 months (12 sessions in total), and PTSD status will be followed up monthly.
  • Keep a record of symptoms, difficulties/challenges faced in managing PTSD, the number of times they experience PTSD symptoms, and improvement over time.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

3 active sites

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

July 30, 2024

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2025

Completed
19 days until next milestone

First Posted

Study publicly available on registry

August 8, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2025

Completed
Last Updated

May 1, 2026

Status Verified

July 1, 2025

Enrollment Period

1.2 years

First QC Date

July 20, 2025

Last Update Submit

April 27, 2026

Conditions

Keywords

Post-Traumatic Stress DisorderCapacity BuildingScreeningPTSD ManagementHealthcare workersRoad Traffic InjuryPrevalenceAssociated factorsCameroon

Outcome Measures

Primary Outcomes (1)

  • Proportion of eligible RTI survivors screened for PTSD at the 1-month follow-up visit in the hospital.

    The percentage of eligible road traffic injury (RTI) survivors presenting to the participating health facility for the intervention (Buea Regional Hospital) who are screened for Post-Traumatic Stress Disorder (PTSD) using a standardized screening tool (e.g., PCL-5) at the participants (RTI survivors) 1-month follow-up visit following capacity building of healthcare workers. The unit of measurement is percentage.

    Measured at 1 month post-injury (following capacity building of HCWs) and followed up for 6 months.

Secondary Outcomes (3)

  • Change in healthcare workers Knowledge of PTSD management.

    Day 1 (baseline), day 2 (at the end of training), and day 30 (after capacity building).

  • Change in Healthcare worker Comfort (HCW) Level in PTSD Management

    Day 1 (baseline), day 2 (at the end of training), and day 30 (after the capacity-building intervention).

  • Proportion of PTSD-positive screens referred for treatment.

    6 months after training

Study Arms (1)

PTSD cases followed up in a pre/post quasi study for 6 months and pre/post PTSD scores compared.

EXPERIMENTAL

* Intervention 1: Capacity building of healthcare workers Capacity building of healthcare workers on PTSD management. Pre/post capacity building scores of HCWs will be measured and compared (t-test) to assess change in knowledge and comfort level in PTSD management. * Intervention 2: Pre/Post Quasi-Experimental Design (QED) with no control group for RTI victims with PTSD. A single-arm study with no control group will be included. Participants (RTI patients) diagnosed with PTSD in the baseline study during the determination of the prevalence of PTSD in the intervention group (Buea Regional Hospital) receive psychotherapy during 6 months of follow-up. Psychotherapy sessions will be done every two weeks for 6 months. PTSD score measurement and pre/post PTSD score comparison to evaluate the impact of timely management with psychotherapy of PTSD among RTI patients. Conclusion and recommendations on trauma quality care improvement of PTSD among RTI patients in HFs in Fako Division.

Behavioral: Two days, role play, adult interactive capacity building sessions of healthcare workers on PTSD screening and management. Pre/posttest and change in practice in screening will be used for evaluation

Interventions

Intervention 1\. Capacity Building of Healthcare workers on PTSD Management For training, the three purposefully selected health facilities selected for the study were written on small pieces of paper. The papers were twisted and thrown on a table. Then, a child was asked to pick up any paper. The one picked was the intervention health facility (Buea Regional Hospital). Healthcare workers at the BRH who provide care to RTI survivors at risk of PTSD 1 month after RTI from our health units of interest in the BRH, will be selected for training (mostly unit heads and front-line staff in trauma/injury will be trained) in two role-play, adult training, interactive sessions on the screening of PTSD using the DSM-5 tool and on timely management of RTI patients with regard to PTSD, linkage to care to psychotherapists, and referrals. Pre/post knowledge evaluation on the use of the DSM-5 tool and management of PTSD will be done, and results compared.

PTSD cases followed up in a pre/post quasi study for 6 months and pre/post PTSD scores compared.

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Health care workers at the selected hospital for intervention in Fako Division (Buea Regional Hospital).
  • Involved in trauma/RTI injury care.
  • Have at least one year of working experience with RTI patients.
  • At least 18 years old and above and consent to the study.

You may not qualify if:

  • \- Healthcare worker who will be sick or not available on days of the training.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Buea Regional Hospital

Buea, Cameroon

Location

Saint Luke Hospital

Buea, Cameroon

Location

Limbe Regional Hospital

Limbe, Cameroon

Location

Related Links

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Stress Disorders, TraumaticTrauma and Stressor Related DisordersMental Disorders

Study Officials

  • Claudia Ngeha Ngu, PhD Fellow

    University of Buea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Model Details: Study Design This will be a hospital- and community-based intervention study. It will be a sequential study using mixed methods. The study will employ multistage sampling and also involve intervention consisting of capacity building and a non-randomized trial in which a pre/post quasi-experimental design (QED) without a control group will be used to evaluate the feasibility and effectiveness of the intervention (linkage to psychotherapy) in Fako Division, Cameroon. The aim for the QED is to evaluate the feasibility of linkage to mental health care (psychotherapy) in managing PTSD and improving RTI patients' outcomes, as this is a pilot feasibility study, as this has been proven in different settings to be effective; hence there is no equipoise. As a second intervention, the pre/post QED will evaluate the management of PTSD using psychotherapy among 89 (eighty-nine) RTI patients (intervention group) selected by simple random sampling.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator/ PhD Fellow

Study Record Dates

First Submitted

July 20, 2025

First Posted

August 8, 2025

Study Start

July 30, 2024

Primary Completion

September 30, 2025

Study Completion

October 30, 2025

Last Updated

May 1, 2026

Record last verified: 2025-07

Data Sharing

IPD Sharing
Will share

Individual participants data that underline the results reported in the study will be made available after de-identification. Data will be shared with researchers who provide methodologically sound proposals and agree to use data only for research purposes. Data will be available starting 6 months after publication and for upto 5 years. To request access, contact the principal investigator.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
6 months after publication and 5 years after the start date
Access Criteria
Individual participant data (IPD) and supporting documents will be accessible to qualified researchers who submit a scientifically sound research proposal related to the study objectives. Researchers must agree to use data solely for research purposes and to maintain participant confidentiality. Access will be granted after approval by the principal investigator or the study steering committee. Data and documents will be shared via secure data transfer methods upon signing a data use agreement. Requests can be submitted by contacting the principal investigator at nguclaudia2018@gmail.com
More information

Locations