Mental Health IssueNCT06272526
Internet-Based Self-Help Intervention for Social Anxiety Symptoms
A study testing Internet Based Intervention - GUIDED in people with Mental Health Issue, run by Anadolu University.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mental Health Issue
- What is being tested?
- Internet Based Intervention - GUIDED
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- receiving any psychological help (i.e., medication or psychotherapy/counseling) during the research period
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Mental Health Issue
- Being tested
- Internet Based Intervention - GUIDED
- Keywords
- Cognitive Behavioral Therapy, Web-based intervention, procrastation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Internet Based Intervention - GUIDEDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Guided Web-Based Intervention | Experimental | Participants in this group will use the web-based intervention (https://kendikendineyardim.org) with guidance support. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
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.
Measured: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
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.
Measured: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Feb 2024
- Study start1 May 2024 (estimated)
- Primary completion1 Oct 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental Health IssueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anadolu University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06272526
- Sponsor's protocol ID
- SOCIALANX_1
- Status last verified
- Feb 2024
- First submitted
- 14 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acceptability and Effectiveness Study of Internet Based Social Anxiety Intervention for University Students in Turkey : A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06272526
- Acronym / sponsor ID
- SOCIALANX_1
- Conditions
- Mental Health Issue
- Keywords
- Cognitive Behavioral Therapy, Web-based intervention, procrastation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Anadolu UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 1 Oct 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 22 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Guided Web-Based Intervention | Experimental | Other: Internet Based Intervention - GUIDEDParticipants in this group will use the web-based intervention (https://kendikendineyardim.org) with guidance support. |
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- receiving any psychological help (i.e., medication or psychotherapy/counseling) during the research period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Internet Based Intervention - GUIDEDThe 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. | Other | Guided Web-Based Intervention |
Primary outcome
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.
3 secondary outcomes
Social Appearance Anxiety Scale (SAAS) Turkish Form
Time frame: 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)
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Feb 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Internet Based Intervention - GUIDED in people with Mental Health Issue, run by Anadolu University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ömer Özer, Ph.D. (5437446687, omer_ozer@anadolu.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Liebowitz Social Anxiety Scale (LSAS) Turkish Form (time frame: Baseline, post-test (6 weeks later from baseline), follow up (10 weeks later from baseline)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Feb 2024.