Post Traumatic Stress SymptomsNCT07768540

Effectiveness of Cognitive Behavioral Intervention for Trauma in Schools (CBITS): A Study With Pakistani Adolescents

A study testing cognitive behavioral intervention for trauma in schools in people with Post Traumatic Stress Symptoms and Psychological Distress, run by National University of Modern Languages at 1 site in Pakistan.

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Sites and contacts

Official record

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Trial summary

Who is it for?: Ages 10 to 16 yearsHealthy volunteers can take part
Conditions the study is for: Post Traumatic Stress Symptoms, Psychological Distress, Trauma Exposure
What is being tested?: cognitive behavioral intervention for trauma in schools
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 sitePakistan
Study dates: 1 Dec 2025to 28 Feb 2027
Phase: Interventional

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 10 to 16 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Students who are 10-16 years of age, have experienced at least one trauma.

Who cannot join

Students who have sexual abuse as only traumatic event

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Pakistan1 site, 1 recruiting

National University Of Modern Languages (NUML), Islamabad
Islamabad
Dr Tasnim Rehna, Assistant Professor, Head of the Department, +923215006165, trehna@numl.edu.pk
Recruiting

Other trials in Pakistan

About this study

This study will evaluate whether a school-based counseling program, Cognitive Behavioral Intervention for Trauma in Schools (CBITS), helps reduce trauma-related symptoms and improve psychological functioning in adolescents in Pakistan who have experienced traumatic events. Students will first be screened to identify those with trauma exposure and related symptoms. Eligible students will receive the CBITS program, delivered at their school by the researcher. Researcher will measure changes in trauma-related symptoms and other psychological outcomes before and after the intervention to determine whether the program is effective for this population.

Read the detailed description

Exposure to trauma is common among adolescents in low- and middle-income countries, including Pakistan, where students may experience adverse events such as violence, natural disasters, displacement, or abuse. These experiences can lead to significant psychological distress, including symptoms of post-traumatic stress, anxiety, and depression, which may go unaddressed due to limited access to mental health services in school settings.

Cognitive Behavioral Intervention for Trauma in Schools (CBITS) is a group-based, school-delivered intervention originally developed to address trauma-related symptoms among students exposed to community violence and other traumatic events. The program uses cognitive-behavioral techniques, including psychoeducation, relaxation training, cognitive restructuring, and gradual exposure, to help students process traumatic experiences and reduce associated symptoms.

This study aims to evaluate the effectiveness of CBITS among adolescents in Pakistani schools who have experienced trauma and are exhibiting trauma-related psychological symptoms. Students will be screened using standardized measures to identify eligible participants. Those who meet criteria will receive the CBITS intervention, delivered by trained facilitators in a school-based setting over a series of structured sessions.

The study will assess changes in participants' psychological symptoms and functioning from baseline to post-intervention, in order to determine whether the intervention is associated with meaningful improvement in this population. Findings from this study may help inform the feasibility and cultural adaptation of trauma-focused, school-based mental health interventions in Pakistan and similar contexts.

Conditions: Post Traumatic Stress Symptoms, Psychological Distress, Trauma Exposure
Being tested: cognitive behavioral intervention for trauma in schools

What participants receive

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

cognitive behavioral intervention for trauma in schoolsBehavioural
Participants in the intervention group will receive Cognitive Behavioral Intervention for Trauma in Schools (CBITS), a manualized, school-based group therapy program for adolescents with trauma-related symptoms. The program includes approximately 10 group sessions (45-60 minutes) covering psychoeducation, relaxation training, cognitive restructuring, trauma narrative development, and social problem-solving. Individual sessions may be included to support the trauma narrative component.

Study groups in NCT07768540
Study group	Role	What they receive
Intervention Group (receiving CBITS)	Experimental	Students in this group will receive the Cognitive Behavioral Intervention for Trauma in Schools, during the school hours Receives: Behavioral: cognitive behavioral intervention for trauma in schools
Control Group (waitlist control group)	No intervention	Students in this group will follow their regular school routine without any changes.

What is being measured

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

Child and Adolescent Trauma Screen 2 (Cats-2) Self-Report (7-17 Years)
The Child and Adolescent Trauma Screen 2 (CATS-2) Self-Report (7-17 Years) is used to assess trauma-related symptoms. Possible scores range from 0 to 60, with higher scores indicating more posttraumatic stress symptoms
Measured: Baseline and 10 weeks
Depression Anxiety Stress Scales - Youth Version (DASS-Y)
The Depression Anxiety Stress Scales - Youth Version (DASS-Y) was used to assess psychological distress, with possible scores ranging from 0 to 63, where higher scores indicate greater psychological distress
Measured: Baseline and 10 weeks

Secondary outcomes (3)

Children's Post-Traumatic Cognitions Inventory (CPTCI-S)
Children's Post-Traumatic Cognitions Inventory (CPTCI-S) was used to assess post-trauma appraisals. Possible scores range from 10 to 40, with higher scores indicating greater difficulty in post-traumatic cognitions.
Measured: Baseline and 10 weeks
The Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
The Difficulties in Emotion Regulation Scale Short Form (DERS-SF) was used to assess emotion regulation difficulties. Possible scores range from 18 to 90, with higher scores indicating greater difficulty in emotion regulation.
Measured: Baseline and 10 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
The Multidimensional Scale of Perceived Social Support (MSPSS), was used to assess perceived social support, possible scores range from 1 to 7, high scores indicating greater perceived social support
Measured: Baseline and 10 weeks

Timeline

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

1 Dec 202528 Feb 2027

First posted17 Aug 2026
Study start1 Dec 2025
Primary completionFeb 2027 (estimated)
Study completion28 Feb 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Post Traumatic Stress SymptomsStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07768540
Sponsor's protocol ID: DERB-PSY-2024-011
Status last verified: Aug 2026
First submitted: 11 Aug 2026
Last updated: 17 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

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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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