NCT06272526

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2024

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 14, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 22, 2024

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

February 22, 2024

Status Verified

February 1, 2024

Enrollment Period

5 months

First QC Date

February 14, 2024

Last Update Submit

February 21, 2024

Conditions

Keywords

Cognitive Behavioral TherapyWeb-based interventionprocrastation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • 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)

Other Outcomes (5)

  • Sociodemographic Information Form

    Baseline

  • System Usability Scale (SUS-10) Turkish Form

    Post-test (6 weeks later from baseline)

  • Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form

    Baseline

  • +2 more other outcomes

Study Arms (2)

Guided Web-Based Intervention

EXPERIMENTAL

Participants in this group will use the web-based intervention (https://kendikendineyardim.org) with guidance support.

Other: Internet Based Intervention - GUIDED

Waitlist

NO INTERVENTION

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.

Interventions

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.

Guided Web-Based Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Ömer Özer, Ph.D.

CONTACT

Ali Ercan Altınöz, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 14, 2024

First Posted

February 22, 2024

Study Start

May 1, 2024

Primary Completion

October 1, 2024

Study Completion

December 31, 2024

Last Updated

February 22, 2024

Record last verified: 2024-02