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| Name | Class |
|---|---|
| Green International University | OTHER |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Control | No Intervention | The control arm will receive no intervention except usual care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| MUHAMMAD Muhammad Raashed, Master | Contact | 03337474991 | stunning003@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| MUHAMMAD ARSHED, PhD | University of Lahore | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18374843 | Background | Stein MB, Stein DJ. Social anxiety disorder. Lancet. 2008 Mar 29;371(9618):1115-25. doi: 10.1016/S0140-6736(08)60488-2. | |
| 26361000 | 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. |
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The study protocol, statistical plan, and results will be disseminated through publications in peer-reviewed Journals.
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It is a two-arm 1:1 randomized control trial
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Participants, care providers and outcome assessors will be blinded
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| 6-months from baseline |
| 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. | 6-months from baseline |
| 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. | 6-months from baseline |
| 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. | 6-months from baseline |
| 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). | 6-months from baseline |
| 23842011 | 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. |
| 36858454 | 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. |
| 35493437 | 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. |
| 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. |