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Social AnxietyNCT06562010

Evaluating the Efficacy of Culturally Adapted iCT-SAD

A study testing iCT-SAD-PK in people with Social Anxiety and ICT, run by Universiti Putra Malaysia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Social Anxiety, ICT
What is being tested?
iCT-SAD-PK
Could I receive a placebo?
No, everyone receives an active treatment
How many people
800 participants
Where
No sites listed yet
Study dates
25 Aug 2024to 25 Mar 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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 locations and contacts

No sites are listed yet.

MUHAMMAD Muhammad Raashed, Master contact

03337474991

stunning003@gmail.com

About this study

Official title: 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.

Read the 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

Conditions
Social Anxiety, ICT
Being tested
iCT-SAD-PK

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iCT-SAD-PKBehavioural

    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.

Study groups in NCT06562010
Study groupRoleWhat they receive
Intervention groupExperimentalThe 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.
Receives: Behavioral: iCT-SAD-PK
ControlNo interventionThe control arm will receive no intervention except usual care.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 6-months from baseline

Secondary outcomes (5)

  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 6-months from baseline

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

    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).

    Measured: 6-months from baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Aug 2024
  2. Study start25 Aug 2024 (estimated)
  3. Primary completion5 Feb 2025 (estimated)
  4. Study completion25 Mar 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Model description
It is a two-arm 1:1 randomized control trial
Masking
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
800 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06562010
Sponsor's protocol ID
UIMT
Status last verified
Aug 2024
First submitted
17 Aug 2024
Last updated
20 Aug 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.

Publications

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

    PubMed 18374843

  • 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.

    PubMed 26361000

  • 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.

    PubMed 23842011

  • 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.

    PubMed 36858454

  • 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.

    PubMed 35493437

  • 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.

  • 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.

Questions about this trial

What is this clinical trial studying?

A study testing iCT-SAD-PK in people with Social Anxiety and ICT, run by Universiti Putra Malaysia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 20 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact MUHAMMAD Muhammad Raashed, Master (03337474991, stunning003@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The primary outcome is change in Social Anxiety score (LSAS) (time frame: 6-months from baseline). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06562010, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2024.

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