Internet-Based Self-Help Intervention for Social Anxiety Symptoms

Mental Health Issue Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06272526
• Other study ID #: SOCIALANX_1
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Anadolu University
• Contact: Ömer Özer, Ph.D.
• Phone: 5437446687
• Email: omer_ozer[@]anadolu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: December 31, 2024
• Est. primary completion date: October 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Other:
• Internet Based Intervention - GUIDED
The experimental group participants will be in treatment through web-based intervention consisting of five to seven weeks. The intervention program will be offered to participants through the website https://kendikendineyardim.org, the online self-help platform in Turkey. Participants will be able to use the system with their e-mail addresses and passwords.The intervention consists of five modules consisting of behavioral, emotional and cognitive content. The modules include text, interactive forms, animated videos, audio recordings, and images. Participants in this arm will receive weekly feedback from guides via the platform's message sending feature.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Anadolu University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Sociodemographic Information Form	This form will assess age, gender and whether the participant has received psychotherapy/counselling or medication before as potential covariates.	Baseline
Other	System Usability Scale (SUS-10) Turkish Form	This is a tool aiming to assess the impact of program usability on treatment outcomes. SUS-10 was developed to assess the usability of a system. It consists of 10 items. The items are on a 5-point Likert scale (0-4). The lowest score is 0 and the highest score is 40. A high score indicates high usability. Raw scores are multiplied by 2.5 when calculating. A score above 70 is considered as sufficient usability.	Post-test (6 weeks later from baseline)
Other	Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form	ETAM will use people's opinions/attitudes about internet-based interventions. It consists of 16 items. It is defined as a five-point Likert scale. A high score indicates a positive attitude towards internet-based interventions.	Baseline
Other	Adherence to Intervention	Adherence refers to the degree to which the user follows the program as designed. The calculation of adherence will use the percentage determined by dividing the number of core modules completed by the participant during the post-test by the total number of core modules in the program and multiplying it by 100.	Post-test (6 weeks later from baseline)
Other	Guide Evaluation	It is a one-question assessment in which the participants in the guided intervention group rate the feedback they received at the end of the program and their relationship with the guide. Participants will score their communication with the guide between 1-10 points.	End of the experiment
Primary	Liebowitz Social Anxiety Scale (LSAS) Turkish Form	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.	Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
Secondary	Social Appearance Anxiety Scale (SAAS) Turkish Form	It is a 5-point Likert type scale developed to measure an individual's emotional, behavioral and cognitive concerns about their appearance. The Turkish form of the scale consists of 16 items. The lowest total score from the scale is 16 and the highest score is 80. High scores indicate high social appearance anxiety. It is a self-report tool and participants evaluate themselves.	Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
Secondary	Patient Health Questionnaire-9 (PHQ-9) Turkish Form	For asses depression symptoms level. PHQ-9 consists of 9 items structured on a four-point Likert scale (0-3) to measure the level of depressed mood. The lowest score is 0 and the highest score is 27. A high score indicates a high level of depression. It is a self-report tool and participants evaluate themselves.	Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
Secondary	Generalized Anxiety Disorder-7 (GAD-7) Turkish Form	It will use for anxiety symptoms level. The GAD-7 consists of 7 items structured in a four-point Likert scale to measure anxiety level. The lowest score is 0 and the highest score is 21. A high score indicates a high level of anxiety. It is a self-report tool and participants evaluate themselves.	Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)