Internet-Based Self-Help Intervention for Social Anxiety Symptoms

February 21, 2024 updated by: Anadolu University

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Web-Based Intervention
Participants in this group will use the web-based intervention (https://kendikendineyardim.org) with guidance support.
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.
No Intervention: Waitlist
The waiting list control group participants will be controlled for time and assessed during the first 7-week period. Participants will have no contact with the study team during the waiting period. Immediately after the waiting period, they will receive the internet-based intervention with the experimental group.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sociodemographic Information Form
Time Frame: Baseline
This form will assess age, gender and whether the participant has received psychotherapy/counselling or medication before as potential covariates.
Baseline
System Usability Scale (SUS-10) Turkish Form
Time Frame: Post-test (6 weeks later from baseline)
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)
Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form
Time Frame: Baseline
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
Adherence to Intervention
Time Frame: Post-test (6 weeks later from baseline)
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)
Guide Evaluation
Time Frame: End of the experiment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anadolu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

October 1, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

February 14, 2024

First Submitted That Met QC Criteria

February 21, 2024

First Posted (Estimated)

February 22, 2024

Study Record Updates

Last Update Posted (Estimated)

February 22, 2024

Last Update Submitted That Met QC Criteria

February 21, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • SOCIALANX_1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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