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临床试验/NCT06562010
NCT06562010尚未招募不适用

Evaluating the Efficacy of Culturally Adapted Internet-Delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD) in Pakistan

Universiti Putra Malaysia0 个研究点目标入组 800 人开始时间: 2024年8月25日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
800
主要终点
The primary outcome is change in Social Anxiety score (LSAS)

研究概览

简要总结

The study will adapt and implement a Pakistani version of Internet-delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD), assessing its effectiveness in reducing social anxiety symptoms among Pakistani individuals.

详细描述

The study will adapt and implement a Pakistani version of Internet-delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD), assessing its effectiveness in reducing social anxiety symptoms among Pakistani individuals. This randomized controlled trial will involve culturally tailored online therapy modules, therapist support, and regular progress assessments. The goal is to evaluate the efficacy of iCT-SAD in a Pakistani context, comparing outcomes to a control group. The primary outcome measure is the self-report Liebowitz Social Anxiety Scale, and secondary outcomes include other measures of social anxiety symptoms and processes, general mood and functioning, and response to treatment

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

盲法说明

Participants, care providers and outcome assessors will be blinded

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Primary diagnosis of SAD based on the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
  • Aged 18-75 years
  • Regular, access to an appropriate internet device
  • Resident of Pakistan and can write and speak Urdu
  • Participants not currently undertaking other structured psychological therapy during the trial

排除标准

  • Current psychosis, bipolar disorder, antisocial personality disorder, or alcohol/substance use disorder
  • Active suicidal ideation with intent or plan
  • Previously received CT or cognitive behavioral therapy for SAD

结局指标

主要结局

The primary outcome is change in Social Anxiety score (LSAS)

时间窗: 6-months from baseline

The primary outcome will be measured by Liebowitz Social Anxiety Scale. The 24 items are first rated on a Likert Scale from 0 to 3 on fear felt during the situations, and then the same items are rated regarding avoidance of the situation. Each item is rated on a four-item Likert scale ranging from 0 (no fear/never avoidance) to 3 (high fear/usually avoidance), with lower scores indicating a better outcome

次要结局

  • The secondary outcome is change in Social Cognitions symptoms(6-months from baseline)
  • The secondary outcome is change in depressive symptoms(6-months from baseline)
  • The secondary outcome is change in generalised anxiety symptoms(6-months from baseline)
  • The secondary outcome is change in perceived functional impairment(6-months from baseline)
  • The secondary outcome is change in Social participation and social satisfaction(6-months from baseline)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Arshed Muhammad

PhD studentship

Universiti Putra Malaysia

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