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Evaluating the Efficacy of Culturally Adapted iCT-SAD

ConditionsSocial AnxietyICT
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-75
SponsorUniversiti Putra Malaysia

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • iCT-SAD-PK

    Behavioral

    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.

Treatment groups

800 Participants
are divided into 2 treatment groups
Group A: Intervention groupExperimental treatment 1 intervention
Group B: ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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

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

Time frame
6-months from baseline

Secondary outcomes

1

The secondary outcome is change in Social Cognitions symptoms

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.

Time frame
6-months from baseline
2

The secondary outcome is change in depressive symptoms

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.

Time frame
6-months from baseline
3

The secondary outcome is change in generalised anxiety symptoms

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.

Time frame
6-months from baseline
4

The secondary outcome is change in perceived functional impairment

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.

Time frame
6-months from baseline

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Universiti Putra Malaysia

Lead sponsor

Green International University

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: