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.
Trial summary
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. Read more about this study
- 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
- Are there results?
- Not yet: the study is under way
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
- Recruiting
National University Of Modern Languages (NUML), Islamabad
Islamabad
Dr Tasnim Rehna, Assistant Professor, Head of the Department, +923215006165, trehna@numl.edu.pk
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.
- 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 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.
- 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)
Sponsor and investigators
- Lead sponsor
- National University of Modern Languages
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sana Shaheen, National University of Modern Languages
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Cognitive Behavioral Intervention for Trauma in Schools (CBITS): A Study With Pakistani Adolescents
- ClinicalTrials.gov ID
- NCT07768540
- Acronym / sponsor ID
- DERB-PSY-2024-011
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- National University of Modern LanguagesUniversity, hospital or other
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 28 Feb 2027 (estimated)
- First posted
- 17 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention Group (receiving CBITS) | Experimental | Behavioral: cognitive behavioral intervention for trauma in schoolsStudents in this group will receive the Cognitive Behavioral Intervention for Trauma in Schools, during the school hours |
| Control Group (waitlist control group) | No intervention | –Students in this group will follow their regular school routine without any changes. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Students who are 10-16 years of age, have experienced at least one trauma.
Key exclusion criteria (1 listed)
- Students who have sexual abuse as only traumatic event
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 intervention for trauma in schoolsParticipants 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. | Behavioural | Intervention Group (receiving CBITS) |
Primary outcome
Child and Adolescent Trauma Screen 2 (Cats-2) Self-Report (7-17 Years)
Time frame: Baseline and 10 weeks
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
Depression Anxiety Stress Scales - Youth Version (DASS-Y)
Time frame: Baseline and 10 weeks
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
3 secondary outcomes
Children's Post-Traumatic Cognitions Inventory (CPTCI-S)
Time frame: Baseline and 10 weeks
The Difficulties in Emotion Regulation Scale Short Form (DERS-SF)
Time frame: Baseline and 10 weeks
Multidimensional Scale of Perceived Social Support (MSPSS)
Time frame: Baseline and 10 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2026.
- Individual participant dataSharing planned: No
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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.
National University Of Modern Languages (NUML), Islamabad
Islamabad, Pakistan
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 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.
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 1 inclusion and 1 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: looking for participants now, as of the sponsor's last update on 17 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Child and Adolescent Trauma Screen 2 (Cats-2) Self-Report (7-17 Years) (time frame: Baseline and 10 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Aug 2026.