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Clinical Trials/NCT06272526
NCT06272526
Not Yet Recruiting
N/A

Acceptability and Effectiveness Study of Internet Based Social Anxiety Intervention for University Students in Turkey : A Randomized Controlled Trial

Anadolu University0 sites30 target enrollmentMay 1, 2024

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mental Health Issue
Sponsor
Anadolu University
Enrollment
30
Primary Endpoint
Liebowitz Social Anxiety Scale (LSAS) Turkish Form
Status
Not Yet Recruiting
Last Updated
2 years ago

Overview

Brief Summary

This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist.

The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides.

Detailed Description

This study is a randomized-controlled trial in which the assumed superiority of the module internet-based cognitive behavioral therapy intervention for social anxiety disorder is evaluated compared to a waitlist control group. Participants will be assigned to one of two groups, treatment which have web-based intervention (guided), and waitlist. The intervention program will be offered to treatment group participants (guided) through the website https://kendikendineyardim.org, the unique online self-help platform in Turkey. Participants in the web-based treatment group will receive feedback message within 24 hours after each completed module from the guides. The intervention program consists of five modules. Each module can be completed in 30-40 minutes. Each module starts with the evaluation of the exercises given at the end of the previous module and ends with a between-module exercise. The module includes text, interactive forms, animated videos, audio recordings, and images. The duration of the program will be approximately five to seven weeks. However, participants will be allowed to follow the program at their own speed. No limitations will be imposed other than the completion of no more than one module per day. Users can use the system with their e-mail addresses and passwords. The data will be compared with suitable statistical techniques.

Registry
clinicaltrials.gov
Start Date
May 1, 2024
End Date
December 31, 2024
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Anadolu University
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • volunteering to participate in the study;
  • having a valid e-mail address;
  • having internet access (computer, laptop, tablet, or mobile device);
  • being aged 18 or older;
  • score of 25 or above on both anxiety and avoidance subscales of the Liebowitz Social Anxiety Scale Turkish Form

Exclusion Criteria

  • receiving any psychological help (i.e., medication or psychotherapy/counseling) during the research period

Outcomes

Primary Outcomes

Liebowitz Social Anxiety Scale (LSAS) Turkish Form

Time Frame: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)

This scale, developed by Liebowitz (1987), aims to evaluate in which social situations individuals with social phobia encounter anxiety. It includes 24 items divided into two subscales addressing social interaction (11 items) and performance (13 items). Items are rated on a 4-point scale for anxiety. When looking at the scoring of the scale, the higher the individual scores, the more anxiety and avoidance behaviors they have. It is a self-report tool and participants evaluate themselves.

Secondary Outcomes

  • Social Appearance Anxiety Scale (SAAS) Turkish Form(Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline))
  • Patient Health Questionnaire-9 (PHQ-9) Turkish Form(Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline))
  • Generalized Anxiety Disorder-7 (GAD-7) Turkish Form(Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline))

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