Evaluating the Efficacy of Culturally Adapted iCT-SAD

NCT06562010 | Not Yet Recruiting DMC

• 1 other identifier: UIMT
• Study Type: interventional
• Target: 800
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Social Anxiety; ICT

Outcome Measures

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

  6-months from baseline

Secondary Outcomes (5)

• The secondary outcome is change in Social Cognitions symptoms

  6-months from baseline

• The secondary outcome is change in depressive symptoms

  6-months from baseline

• The secondary outcome is change in generalised anxiety symptoms

  6-months from baseline

• The secondary outcome is change in perceived functional impairment

  6-months from baseline

• The secondary outcome is change in Social participation and social satisfaction

  6-months from baseline

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control

NO INTERVENTION

The control arm will receive no intervention except usual care.

Interventions

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.

Intervention group

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Universiti Putra Malaysia: lead
• Green International University: collaborator

Related Publications (7)

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

  PMID: 18374843 BACKGROUND

• 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.

  PMID: 26361000 BACKGROUND

• 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.

  PMID: 23842011 BACKGROUND

• 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.

  PMID: 36858454 BACKGROUND

• 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.

  PMID: 35493437 BACKGROUND

• 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.

  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.

  BACKGROUND

Study Officials

• MUHAMMAD ARSHED, PhD

  University of Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

MUHAMMAD Muhammad Raashed, Master

CONTACT

03337474991; stunning003@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Participants, care providers and outcome assessors will be blinded
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD studentship

Model Details: It is a two-arm 1:1 randomized control trial

Study Record Dates

• First Submitted: August 17, 2024
• First Posted: August 20, 2024
• Study Start: August 25, 2024
• Primary Completion: February 5, 2025
• Study Completion: March 25, 2025
• Last Updated: August 20, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share