Evaluating the Efficacy of Culturally Adapted iCT-SAD

NCT ID: NCT06562010

Last Updated: 2024-08-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-25

Study Completion Date

2025-03-25

Brief Summary

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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

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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

Conditions

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Social Anxiety ICT

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

It is a two-arm 1:1 randomized control trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors
Participants, care providers and outcome assessors will be blinded

Study Groups

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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.

Group Type EXPERIMENTAL

iCT-SAD-PK

Intervention Type 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.

Control

The control arm will receive no intervention except usual care.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Green International University

OTHER

Sponsor Role collaborator

Universiti Putra Malaysia

OTHER

Sponsor Role lead

Responsible Party

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Arshed Muhammad

PhD studentship

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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MUHAMMAD ARSHED, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Lahore

Central Contacts

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MUHAMMAD Muhammad Raashed, Master

Role: CONTACT

03337474991

References

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Stein MB, Stein DJ. Social anxiety disorder. Lancet. 2008 Mar 29;371(9618):1115-25. doi: 10.1016/S0140-6736(08)60488-2.

Reference Type BACKGROUND
PMID: 18374843 (View on PubMed)

Mayo-Wilson E, Dias S, Mavranezouli I, Kew K, Clark DM, Ades AE, Pilling S. Psychological and pharmacological interventions for social anxiety disorder in adults: a systematic review and network meta-analysis. Lancet Psychiatry. 2014 Oct;1(5):368-76. doi: 10.1016/S2215-0366(14)70329-3. Epub 2014 Oct 7.

Reference Type BACKGROUND
PMID: 26361000 (View on PubMed)

McHugh RK, Whitton SW, Peckham AD, Welge JA, Otto MW. Patient preference for psychological vs pharmacologic treatment of psychiatric disorders: a meta-analytic review. J Clin Psychiatry. 2013 Jun;74(6):595-602. doi: 10.4088/JCP.12r07757.

Reference Type BACKGROUND
PMID: 23842011 (View on PubMed)

Iacobucci G. NICE recommends online therapies to treat depression and anxiety in adults. BMJ. 2023 Mar 1;380:495. doi: 10.1136/bmj.p495. No abstract available.

Reference Type BACKGROUND
PMID: 36858454 (View on PubMed)

Thew GR, Kwok APL, Lissillour Chan MH, Powell CLYM, Wild J, Leung PWL, Clark DM. Internet-delivered cognitive therapy for social anxiety disorder in Hong Kong: A randomized controlled trial. Internet Interv. 2022 Apr 18;28:100539. doi: 10.1016/j.invent.2022.100539. eCollection 2022 Apr.

Reference Type BACKGROUND
PMID: 35493437 (View on PubMed)

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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND

Other Identifiers

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UIMT

Identifier Type: -

Identifier Source: org_study_id

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