Evaluating the Efficacy of Culturally Adapted iCT-SAD

Not Applicable

Not yet recruiting

• Conditions: Social Anxiety; ICT
• Interventions: Behavioral: iCT-SAD-PK

• Registration Number: NCT06562010
• Lead Sponsor: Universiti Putra Malaysia

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

Study Timeline

• Status Verified: 2024-08
• Study First Submitted: 2024-08-17
• Study First Submitted QC: 2024-08-17
• Last Update Submitted: 2024-08-17
• Study First Posted: 2024-08-20
• Last Update Posted: 2024-08-20
• Study Start: 2024-08-25
• Primary Completion: 2025-02-05
• Study Completion: 2025-03-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 800

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	iCT-SAD-PK	The intervention arm will receive 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 will involve culturally tailored online therapy modules, therapist support, and regular progress assessments.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The secondary outcome is change in Social Cognitions symptoms	6-months from baseline	The secondary outcome will be measured by the Social Cognitions Questionnaire (SCQ). SCQ is a 22-item scale that assesses the most common negative automatic thoughts related to SAD. Each thought is rated in terms of how often it occurred in the last week and how much it is believed. The mean scores for frequency (mean ranges from 1 to 5) and for belief (mean ranges from 0 to 100) are computed separately, with lower scores indicating a better outcome.
The secondary outcome is change in depressive symptoms	6-months from baseline	The secondary outcome will be measured by the Patient Health Questionnaire (PHQ-9). PHQ-9 is a scale that will be used for assessing depressive symptoms. This scale contains 9 questions answered on a 4-point Likert scale, with numbers from 0 (not at all) to 3 (nearly every day). A higher score reflects more severe symptoms.
The secondary outcome is change in generalised anxiety symptoms	6-months from baseline	GAD-7 is a validated questionnaire commonly used to assess generalized anxiety symptoms and their severity. This scale consists of 7 questions answered on a 4-item Likert scale, with numbers from 0 (not at all) to 3 (nearly every day). A higher score reflects more severe symptoms.
The secondary outcome is change in perceived functional impairment	6-months from baseline	WSAS is a five-item scale that measures perceived functional impairment across five domains: work, home management, social leisure activities, private leisure activities, and relationships with others. Each item is rated on a 9-point severity scale ranging from 0 (not at all) to 8 (very severely), based on the degree to which the issue impedes one's ability to perform an activity.
The secondary outcome is change in Social participation and social satisfaction	6-months from baseline	Social participation and social satisfaction will be measured with Alden and Taylor's scales. Social participation has 13 items that ask about the frequency of participation in social interactions, events, and conversations in the last month. Each item is rated from 1 (not at all) to 7 (frequently). Social satisfaction has five items that ask about satisfaction with relationships with colleagues, friends, and partners in the last month. Each item is rated from 1 (not satisfied at all) to 7 (very satisfied).