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NCT Number: NCT06562010

Evaluating the Efficacy of Culturally Adapted iCT-SAD

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.

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Key information

Conditions

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

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

    Time frame: 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 outcomes

  1. The secondary outcome is change in Social Cognitions symptoms

    Time frame: 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.

  2. The secondary outcome is change in depressive symptoms

    Time frame: 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.

  3. The secondary outcome is change in generalised anxiety symptoms

    Time frame: 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.

  4. The secondary outcome is change in perceived functional impairment

    Time frame: 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.

  5. The secondary outcome is change in Social participation and social satisfaction

    Time frame: 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).

Study contacts

Contact information is provided by the study sponsor or research team.

MUHAMMAD Muhammad Raashed, Master

CONTACT

[email protected]

03337474991

Sponsors and collaborators

Lead sponsor

Universiti Putra Malaysia

Other

Collaborators

  • Green International University

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 20, 2024
Registry last updated
Aug 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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