RCT of CBT Based C.A.T Project for Pakistani Adolescents With Anxiety Disorders.

NCT07202715 | Active Not Recruiting DMC

• 1 other identifier: 0839
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 3

Brief Summary

Anxiety Disorders are the most prevalent mental health conditions among adolescents. The current randomized control trial aims to assess the efficacy of the C.A.T Project protocol among adolescents aged 14 to 17 years diagnosed with severe to moderate anxiety disorders in school settings. The research explores the impact of the intervention on reducing acute and chronic symptoms of anxiety, academic performance, self concept, overall wellbeing, internalizing and externalizing behaviors among school going adolescents with anxiety concerns. The intervention integrates various components of Cognitive Behavioral Therapy using cognitive restructuring, parental psychoeducation, behavioral activation, problem solving and relaxation exercise. The study had already completed translation and adaptation of the C.A.T Workbook for adolescents in Urdu language and context using Brislin (1976) and WHO (2023) guidelines. The CBT model is a multifaceted, evidence-based treatment for adolescents diagnosed with various kinds of anxiety disorders. It aims to identify and change unhelpful thought patterns to more helpful thinking leading to positive emotions and behaviors. It also is evidenced to be effective with various levels of severity and comorbidity. In this study, the 16-week intervention will be tested through a randomized waitlist/TAU trial, where 50 participants are be divided into intervention and control arms. In addition to various outcomes, the research also aims to evaluate fidelity, feasibility and acceptability of the protocol at school setting in Pakistan. Post and 3 month follow up will be explored to determine immediate and long-term treatment efficacy.

Conditions

Anxiety Disorder of Adolescence

Keywords

Adolescent Anxiety Disorders, CBT, RCT

Outcome Measures

Primary Outcomes (4)

• Screen for Child Anxiety Related Emotional Disorders

  The Screen for Child Anxiety Related Emotional Disorders (SCARED) scale will be used with adolescents. The scale ranges from 0 to 82, with higher scores indicating greater severity of anxiety symptoms (i.e., a worse outcome)

  Pretesting phase, 4 month and 3 month followup

• Fear Survey Schedule for Children-Revised

  The Fear Survey Schedule for Children-Revised (FSSC-R), Urdu version will be used with adolescents. The scale ranges from 80 to 240, with higher scores indicating greater severity of fears (i.e., a worse outcome).

  Pretesting phase, 4 months and 3 month followup

• Diagnostic Assesment on Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime

  The Kiddie Schedule for Affective Disorders and Schizophrenia-Present and Lifetime Version (K-SADS-PL), Urdu version, will be used with adolescents. This is a semi-structured diagnostic interview rather than a numerical scale, so it does not have a minimum or maximum score. Outcomes are reported as the presence or absence of psychiatric diagnoses based on DSM criteria, with endorsement of a diagnosis reflecting a worse outcome.

  Pretesting phase, 4 month and 3 month followup

• Childhood Anxiety Sensitivity Index

  The Childhood Anxiety Sensitivity Index (CASI) will be used with adolescents. The scale ranges from 18 to 54, with higher scores indicating greater anxiety sensitivity (i.e., a worse outcome).

  Pretesting phase, 4 month and 3 month followup

Secondary Outcomes (13)

• Strengths and Difficulties Questionnaire (SDQ)

  Pretesting, 4 months and 3 month followup

• Adolescent's Self-Concept Short Scale

  Pretesting, 4 months and 3 month followup

• WHO-5 Well-Being Index for Adolescents

  Pretesting, 4 months and 3 month followup

• Smartphone Addiction Scale - Short Version

  4 months and 3 month followup

• Competence and Adherence Scale for CBT (CAS-CBT)

  4 months

Study Arms (2)

Experimental Group - C.A.T Project Intervention

EXPERIMENTAL

In this group 25 participants will receive C.A.T Project (CBT based treatment for anxious adolecents) intervention program. This is an evidence based 16 week program designed to alleviate the symptoms of anxiety disorder among teenagers. The intervention will be delivered over 16 weeks, with weekly structured and videoptapped sessions involving adolescents and their parents. 14 sessions are delivered to adolescents and 2 sessions are parental sessions. The sessions will be delivered in groups of 3-5 students. The program includes psychoeducation, learing coping skills, enhancing emotional regulation, problem solving, relaxation and exposure exercises. Parents and teachers will be actively engaged througout the program.

Behavioral: CBT Based C.A.T Project- Intervention for Anxious Adolescents.

Waitlist/TAU Group- no Intervention

NO INTERVENTION

25 participants in the waitlist/TAU group will receive no active intervention during the study period but continued to access routine care/ teacher's guidance as available. After the trial and 3 month followup will end, they will be offered the experimental intervention. The waitlist/TAU group will serve as a control condition, allowing researchers to compare the effects of the intervention against participants receiving only standard and usual care.

Interventions

CBT Based C.A.T Project- Intervention for Anxious Adolescents. BEHAVIORAL

The C.A.T Project is a structured, evidence-based intervention grounded in Cognitive Behavioral Therapy (CBT) principles, designed specifically for adolescents experiencing anxiety and related concerns. The core components includes: Psychoeducation, Cognitive Restructuring, Exposure Exercises, Coping Skills Training and Relapse Prevention. This age appropriate intervention will be delivered in Urdu language with culturally appropriate context.

Experimental Group - C.A.T Project Intervention

Eligibility Criteria

• Age: 14 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Participants aged 14-17-year-old in school setting, who score above the cutoff score (25) on SCARED (Screening for Child Anxiety Related Disorders) for Child and/or Parent version become part of this study. Further diagnostic interviewing is carried out to explore severity and comorbidity using structured and urdu translated Kiddie SADS-PL diagnotic interviewing protocol.

You may not qualify if:

• Students who score below the cutoff score of 25 on SCARED (Screening for Child Anxiety Related Disorders) assessment for Child and/or Parent version are not part of the study. Students who were screened for Neurodevelopmental concerns like ADHD and ASD using Kiddie SADS- PL interview protocols are not considered to be part of the study. In addition, participants who are currently undergoing medical/psychological treatment for their anxiety related concerns are not part of this study.

Sponsors & Collaborators

• National University of Science and Technology: lead

Study Sites (3)

CRM School system

Rawalpindi, Punjab Province, 46000, Pakistan

Location

Amblem School System

Rawalpindi, Punjab Province, Pakistan

Location

Spangle House School

Rawalpindi, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Color Vision Defects

Condition Hierarchy (Ancestors)

Vision Disorders; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Cone Dystrophy; Eye Diseases, Hereditary; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Annum Tanweer

  School of Social Sciences and Humanities, NUST, Islamabad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The outcome measure assesments before, during and after intervention will be completed and assessed by an independent team of 2 clinical psychologists. 3 month Followup assessment will be carried out by independent team of 2 psychologists .
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, PhD Scholar

Model Details: 50 students, who screened postive for anxiety disorders using SCARED screening tool were randomly selected from three randomly selected schools (selected from online PEPRIS List of schools in Rawalpindi) for the study. 50 students were then randomly assigned to either an experimental or waitlist/TAU group. 16 week CBT based C.A.T Project treatment will be given to the participants in experimental group.

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: October 2, 2025
• Study Start: July 7, 2025
• Primary Completion: March 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: October 2, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

PA (3)