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

NCT ID: NCT07202715

Last Updated: 2025-10-02

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2026-07-31

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.

Detailed Description

The current research is a randomized control trial to evaluate the efficacy of the CBT based C.A.T Project for adolescents aged 14-17 years with anxiety disorders. Globally and locally anxiety disorders are one of the most prevalent mental health concerns among adolescents and young adults (WHO, 2025), however in developing concerns it remains underdiagnosed and untreated especially among school going adolescents. The study aims to address this gap by adapting evidence-based resources and implementing them in Pakistani context. In the first phase of the study the C.A.T Workbook (Kendall 1994, 1997) for adolescents was linguistically translated and culturally adapted using WHO (2023) and Brislin (1976) guidelines using procedures like expert panel review, cognitive interviewing and content validity assessment (CVI =0.96).

Integrating Cognitive Behavioral approach, the C.A.T Project for adolescents include the following components: Therapist manual and teen workbook (translated and culturally adapted in Urdu), parental and adolescent psychoeducation, changing adolescent's negative perceptions and cognitions, weekly homework exercises, exposure tasks.

To select participants in the current trial, 3 schools in Rawalpindi, Pakistan were randomly selected from the online PEPRIS List. Adhering to all the ethical requirements of assent and consent from various stakeholders, students were screened for anxiety disorders using standardized and adapted tools. 50 students, who screened postive for anxiety disorders using SCARED screening tool were randomly selected from those selected school for the study. 50 students were then randomly assigned to either an experimental or waitlist/TAU group. Further assessment on outcome measures and standardized diagnostic interviewing using Kiddie SADS protocol was carried out using culturally adapted measures. The intervention is delivered to groups of 3-5 students per session. The intervention is 16 weeklong, with one session per week. 14 sessions are for adolescents while 2 sessions are for their parents. Outcome measures are assessed before, during and post intervention with a 3-month follow-up assessment. These assessments from adolescents, parents and teachers are carried out by an independent team of clinical psychologists to reduce bias. Outcome measures include evaluating acute and chronic symptoms of anxiety in various time points, academic performance, their self-concept, overall mental wellbeing, screentime addiction, physical activity, internalizing and externalizing behaviors like emotional symptom, conduct problems, hyperactivity-inattention, peer problems and prosocial behavior among school going adolescents with anxiety concerns. Overall mental wellbeing of parents and teachers are also noted.

The current study adheres to the CONSORT guidelines for feasibility studies. Keeping in view of the confidentiality and privacy of the participants, each session is video recorded and is evaluated by an independent team of clinical psychologists using standardized feasibility and protocol adherence questionnaires. The result of this study is expected to show the reduction of symptoms of anxiety disorders, improve adolescent's overall mental wellbeing and inform evidence on scalability, practicality and effectiveness of CBT based standard mental health services in school settings.

The description of the study is clear and adheres to the requirements and guidelines of ClinicalTrials.gov. It mentions the purpose, design, methodology and expected findings of the study.

Objectives:

The main objectives of the study are

1. To determine the fidelity, feasibility and acceptability of the CBT based C.A.T Project for adolescents in Pakistani context.

2. To linguistically translate and culturally adapt the CBT based C.A.T Project Workbook for Project for use with Urdu-speaking adolescents in Pakistan.

3. To evaluate the efficacy of C.A. T Project treatment compared to standard care alleviate symptoms of anxiety disorders among adolescents in school setting.

4. To assess the impact of C.A. T Project intervention on academic performance, internalizing and externalizing behaviors, overall wellbeing and self-concept among adolescents diagnosed with anxiety disorders.

5. To investigate the impact of C.A.T Project intervention on screentime addiction of adolescents diagnosed with anxiety disorders.

6. To evaluate the maintenance of treatment effects in adolescents diagnosed with anxiety disorders through 3-month post treatment follow up.

Hypothesis:

1. Adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant improvement in their acute and chronic symptoms of anxiety disorders from their baseline and as compared to the waitlist/TAU group.

2. Adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant improvement in internalizing and externalizing behaviors, as compared to the waitlist/TAU group.

3. Parents and adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant improvement in overall mental wellbeing as compared to the waitlist/TAU group.

4. Adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant reduction in experiencing screentime addiction as compared to thewaitlist/TAU group.

5. Adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant improvement in physical activity as compared to the waitlist/TAU group.

6. Adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant improvement in their self-concept as compared to the waitlist/TAU group.

7. Teachers and Parental overall mental wellbeing will have a statistically significant relationship with overall mental wellbeing of the Adolescents with Anxiety Disorder.

8. Adolescents with Anxiety Disorder who receive CBT based C.A.T Project intervention will demonstrate statistically significant improvement in their acute and chronic symptoms of anxiety disorders and outcome measures from their baseline and as compared to the waitlist/TAU group after 3 month followup.

Conditions

Anxiety Disorder of Adolescence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Experimental Group - C.A.T Project Intervention

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.

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

Waitlist/TAU Group- 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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National University of Science and Technology

OTHER

Sponsor Role: lead

Responsible Party

Annum Tanweer

Principal Investigator, PhD Scholar

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Annum Tanweer

Role: PRINCIPAL_INVESTIGATOR

School of Social Sciences and Humanities, NUST, Islamabad

Locations

CRM School system

Rawalpindi, Punjab Province, Pakistan

Amblem School System

Rawalpindi, Punjab Province, Pakistan

Spangle House School

Rawalpindi, Punjab Province, Pakistan

Countries

Pakistan

Other Identifiers

0839

Identifier Type: -

Identifier Source: org_study_id