Evaluating the Efficacy of Culturally Adapted iCT-SAD

August 17, 2024 updated by: Arshed Muhammad, Universiti Putra Malaysia

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention group
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.
Behavioral: 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.
No Intervention: Control
The control arm will receive no intervention except usual care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6-months from baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6-months from baseline
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.
6-months from baseline
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.
6-months from baseline
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.
6-months from baseline
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).
6-months from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universiti Putra Malaysia

Collaborators

Green International University

Investigators

  • Principal Investigator: MUHAMMAD ARSHED, PhD, University of Lahore

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 25, 2024

Primary Completion (Estimated)

February 5, 2025

Study Completion (Estimated)

March 25, 2025

Study Registration Dates

First Submitted

August 17, 2024

First Submitted That Met QC Criteria

August 17, 2024

First Posted (Actual)

August 20, 2024

Study Record Updates

Last Update Posted (Actual)

August 20, 2024

Last Update Submitted That Met QC Criteria

August 17, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UIMT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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