Clinical trial NCT06562010: Evaluating the Efficacy of Culturally Adapted iCT-SAD
Official title: Evaluating the Efficacy of Culturally Adapted Internet-Delivered Cognitive Therapy for Social Anxiety Disorder (iCT-SAD) in Pakistan
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Social Anxiety
ICT
Lead sponsor: Universiti Putra Malaysia
Sponsor class: OTHER
Collaborators: name: Green International University
First posted: 2024-08-20
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: It is a two-arm 1:1 randomized control trial
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The primary outcome is change in Social Anxiety score (LSAS)
timeFrame: 6-months from baseline
Secondary outcomes:
measure: The secondary outcome is change in Social Cognitions symptoms
timeFrame: 6-months from baseline
measure: The secondary outcome is change in depressive symptoms
timeFrame: 6-months from baseline
measure: The secondary outcome is change in generalised anxiety symptoms
timeFrame: 6-months from baseline
measure: The secondary outcome is change in perceived functional impairment
timeFrame: 6-months from baseline
measure: The secondary outcome is change in Social participation and social satisfaction
timeFrame: 6-months from baseline
Other outcomes:
Locations:
Study officials:
affiliation: University of Lahore
name: MUHAMMAD ARSHED, PhD
role: PRINCIPAL_INVESTIGATOR
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citation: Yoshinaga N, Thew GR, Kobori O, Hayashi Y, Clark DM. Lost in translation? Cultural adaptation of treatment content for Japanese internet-based cognitive therapy for social anxiety disorder. J Behav Cogn Ther. 2021;31(4):363-8. https://doi.org/10.1016/j.jbct.2021.05.004.
citation: Brown TA, Barlow DH. Anxiety and Related Disorders Interview Schedule for DSM-5 (ADIS-5)-adult and lifetime version: Clinician manual. Oxford: Oxford University Press; 2014.