Clinical trial NCT06272526: Internet-Based Self-Help Intervention for Social Anxiety Symptoms
Official title: Acceptability and Effectiveness Study of Internet Based Social Anxiety Intervention for University Students in Turkey : A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: Cognitive Behavioral Therapy
Web-based intervention
procrastation
Lead sponsor: Anadolu University
Sponsor class: OTHER
First posted: 2024-02-22
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Liebowitz Social Anxiety Scale (LSAS) Turkish Form
timeFrame: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
Secondary outcomes:
measure: Social Appearance Anxiety Scale (SAAS) Turkish Form
timeFrame: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
measure: Patient Health Questionnaire-9 (PHQ-9) Turkish Form
timeFrame: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
measure: Generalized Anxiety Disorder-7 (GAD-7) Turkish Form
timeFrame: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
Other outcomes:
measure: Sociodemographic Information Form
timeFrame: Baseline
measure: System Usability Scale (SUS-10) Turkish Form
timeFrame: Post-test (6 weeks later from baseline)
measure: Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form
timeFrame: Baseline
measure: Adherence to Intervention
timeFrame: Post-test (6 weeks later from baseline)
measure: Guide Evaluation
timeFrame: End of the experiment
Locations:
Study officials:
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