跳至主要内容
临床试验/NCT07202715
NCT07202715进行中(未招募)不适用

Efficacy of CBT Based C.A.T Project for Pakistani Adolescents With Anxiety Disorders- A Pilot Randomized Control Trial.

National University of Science and Technology4 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2025年7月7日最近更新:

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
50
试验地点
4
主要终点
Screen for Child Anxiety Related Emotional Disorders

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

盲法说明

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 .

入排标准

年龄范围
14 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Screen for Child Anxiety Related Emotional Disorders

时间窗: Pretesting phase, 4 month and 3 month followup

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)

Fear Survey Schedule for Children-Revised

时间窗: Pretesting phase, 4 months and 3 month followup

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).

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

时间窗: Pretesting phase, 4 month and 3 month followup

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.

Childhood Anxiety Sensitivity Index

时间窗: Pretesting phase, 4 month and 3 month followup

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).

次要结局

  • 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)
  • Summary Therapist Feedback(4 months)
  • Manual Rating Form(4 months)
  • Rates of Perceived Benefits from Treatment(4 months)
  • Weekly Therapist Feedback Form(4 month)
  • Physical Activity (Demographic Variable)(Pretesting, 4 month and 3 month followup)
  • Academic performance (Demographic Variable)(Pretesting, 4 month and 3 month followup)
  • WHO-5 Well-Being Index for parent(Pretesting phase, 4 month and 3 month followup)
  • WHO-5 Well-Being Index for teacher(Pretesting phase, 4 month and 3 month followup)

研究者

发起方
National University of Science and Technology
申办方类型
Other
责任方
Principal Investigator
主要研究者

Annum Tanweer

Principal Investigator, PhD Scholar

National University of Science and Technology

研究点 (4)

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