Mental Health IssueUNIPDESNCT06245200

UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms

A study testing UNIPDES - Internet Based Intervention - GUIDED and UNIPDES - Internet Based Intervention - UNGUIDED in people with Mental Health Issue, run by Anadolu University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

This study is a randomised clinical trial. This study evaluates the effect of an internet-based intervention developed based on a transdiagnostic cognitive behavioural approach on psychological symptoms of university students. 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?: UNIPDES - Internet Based Intervention - GUIDED and UNIPDES - Internet Based Intervention - UNGUIDED
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 330 participants
Where: No sites listed yet
Study dates: 1 May 2024to 25 Aug 2025
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 or mobile device);
being over the age of 18;

Who cannot join

ongoing psychological support/psychotherapy during the research period;
scoring more than 15 on the Patient Health Questionnaire 9 (PHQ 9) and more than 14 on the Generalized Anxiety Disorder-7 (GAD-7) scales

Trial locations and contacts

No sites are listed yet.

ÖMER ÖZER, PH.D. contact

5437446687

omer_ozer@anadolu.edu.tr

Ali Ercan ALTINÖZ, MD contact

5437446687

ercanaltinöz@gmail.com

About this study

Official title: UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms: Evaluation of Its Development, Usability and Effectiveness Study Protocol

Experimental group participants (guided and unguided) will use the UNIPDES programme developed within the scope of the project. Participants in the guided internet-based experimental group will additionally receive weekly feedback from the guide .

Read the detailed description

There is a six-week intervention protocol within the programme. This intervention programme includes structured, emotional, cognitive and behavioural interventions independent of the diagnosis.

Users will complete each module in 30-40 minutes. The programme is structured in a hierarchical order. Each session is a preliminary to the session that follows it.

The data will be compared with suitable statistical techniques.

Conditions: Mental Health Issue
Being tested: UNIPDES - Internet Based Intervention - GUIDED, UNIPDES - Internet Based Intervention - UNGUIDED
Keywords: cognitive behavioral therapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

UNIPDES - Internet Based Intervention - GUIDEDOther
The experimental group participants will receive the internet-based intervention consisting of six weeks. This intervention has cognitive, emotional and behavioral components. Users will be able to use content created with video, audio, animation and interactive forms on their electronic devices (PC; tabs or smartphones). Participants in this arm will receive weekly feedback from counselors through the web software used.
UNIPDES - Internet Based Intervention - UNGUIDEDOther
The experimental group participants will receive the internet-based intervention consisting of six weeks. This intervention has cognitive, emotional and behavioral components. Users will be able to use content created with video, audio, animation and interactive forms on their electronic devices (PC; tabs or smartphones).

Study groups in NCT06245200
Study group	Role	What they receive
Guided Internet Based Intervention	Experimental	Participants in this group will use the UNIPDES intervention with guidance support. Receives: Other: UNIPDES - Internet Based Intervention - GUIDED
Unguided Internet Based Intervention	Experimental	Participants in this group will use the UNIPDES intervention without guidance Receives: Other: UNIPDES - Internet Based Intervention - UNGUIDED
Waitlist	No intervention	Participants in this group will not receive any intervention. However, if they wish, they will be able to access the UNIPDES unguided version when the trial ends.

What is being measured

The primary outcome is the main question the study is designed to answer.

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: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
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: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
The Brief Adjustment Scale-6 (BASE-6) Turkish Form
individual's general psychological distress and adjustment.BASE-6 consists of 6 items structured on a seven-point Likert scale (1-7) to measure the participants' level of adjustment. The lowest score is 7 and the highest score is 42. A high score indicates a high level of negative adjustment and high distress. It is a self-report tool and participants evaluate themselves.
Measured: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)

Secondary outcomes (1)

System Usability Scale (SUS-10) Turkish Form: SUS-10
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.
Measured: post-test (6 weeks later from pre-test)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 May 202425 Aug 2025

First posted7 Feb 2024
Study start1 May 2024 (estimated)
Primary completion1 Dec 2024 (estimated)
Study completion25 Aug 2025 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
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: 330 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06245200
Sponsor's protocol ID: E-80558721-050.99-2300154653
Other IDs: 123K895
Acronym: UNIPDES
Status last verified: Feb 2024
First submitted: 21 Jan 2024
Last updated: 8 Feb 2024
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Informed consent and study protocol will be shared in the academic journal planned to be published. The data will be forwarded to researchers working in this field upon request from the researcher.

Publications

Ozer O, Oztemur G, Altinoz AE, Koksal B, Dogan U, Batmaz S, Gur R, Altinok A. UNIPDES - An internet-based transdiagnostic intervention for college students' psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol. Contemp Clin Trials Commun. 2025 Feb 6;44:101443. doi: 10.1016/j.conctc.2025.101443. eCollection 2025 Apr.
PubMed 40191049

Want to know more?

ÖMER ÖZER, PH.D.

5437446687

omer_ozer@anadolu.edu.tr

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms: Evaluation of Its Development, Usability and Effectiveness Study Protocol
ClinicalTrials.gov ID: NCT06245200
Acronym / sponsor ID: UNIPDES / E-80558721-050.99-2300154653
Conditions: Mental Health Issue
Keywords: cognitive behavioral therapy
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 330 participants (estimated)
Lead sponsor: Anadolu UniversityUniversity, hospital or other
Collaborators: Eskisehir Osmangazi University
Study start: 1 May 2024 (estimated)
Primary completion: 1 Dec 2024 (estimated)
Study completion: 25 Aug 2025 (estimated)
First posted: 7 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.

Detailed description

There is a six-week intervention protocol within the programme. This intervention programme includes structured, emotional, cognitive and behavioural interventions independent of the diagnosis.

Users will complete each module in 30-40 minutes. The programme is structured in a hierarchical order. Each session is a preliminary to the session that follows it.

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: 3

Arm	Type	Receives
Guided Internet Based Intervention	Experimental	Other: UNIPDES - Internet Based Intervention - GUIDEDParticipants in this group will use the UNIPDES intervention with guidance support.
Unguided Internet Based Intervention	Experimental	Other: UNIPDES - Internet Based Intervention - UNGUIDEDParticipants in this group will use the UNIPDES intervention without guidance
Waitlist	No intervention	–Participants in this group will not receive any intervention. However, if they wish, they will be able to access the UNIPDES unguided version when the trial ends.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

volunteering to participate in the study;
having a valid e-mail address;
having internet access (computer or mobile device);
being over the age of 18;

Key exclusion criteria (2 listed)

ongoing psychological support/psychotherapy during the research period;
scoring more than 15 on the Patient Health Questionnaire 9 (PHQ 9) and more than 14 on the Generalized Anxiety Disorder-7 (GAD-7) scales

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
UNIPDES - Internet Based Intervention - GUIDEDThe experimental group participants will receive the internet-based intervention consisting of six weeks. This intervention has cognitive, emotional and behavioral components. Users will be able to use content created with video, audio, animation and interactive forms on their electronic devices (PC; tabs or smartphones). Participants in this arm will receive weekly feedback from counselors through the web software used.	Other	Guided Internet Based Intervention
UNIPDES - Internet Based Intervention - UNGUIDEDThe experimental group participants will receive the internet-based intervention consisting of six weeks. This intervention has cognitive, emotional and behavioral components. Users will be able to use content created with video, audio, animation and interactive forms on their electronic devices (PC; tabs or smartphones).	Other	Unguided Internet Based Intervention

Primary outcome

Patient Health Questionnaire-9 (PHQ-9) Turkish Form
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
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.
Generalized Anxiety Disorder-7 (GAD-7) Turkish Form
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
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.
The Brief Adjustment Scale-6 (BASE-6) Turkish Form
Time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
individual's general psychological distress and adjustment.BASE-6 consists of 6 items structured on a seven-point Likert scale (1-7) to measure the participants' level of adjustment. The lowest score is 7 and the highest score is 42. A high score indicates a high level of negative adjustment and high distress. It is a self-report tool and participants evaluate themselves.

1 secondary outcome

System Usability Scale (SUS-10) Turkish Form: SUS-10
Time frame: post-test (6 weeks later from pre-test)

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2024.
Derived from this study: PubMed 40191049Ozer O, Oztemur G, Altinoz AE, Koksal B, Dogan U, Batmaz S, Gur R, Altinok A. UNIPDES - An internet-based transdiagnostic intervention for college students' psychological symptoms: Evaluation of its development, usability and effectiveness: Study protocol. Contemp Clin Trials Commun. 2025 Feb 6;44:101443. doi: 10.1016/j.conctc.2025.101443. eCollection 2025 Apr.
Individual participant dataSharing planned: Yes. Informed consent and study protocol will be shared in the academic journal planned to be published. The data will be forwarded to researchers working in this field upon request from the researcher.

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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.

ÖMER ÖZER, PH.D. contact

5437446687

omer_ozer@anadolu.edu.tr

Ali Ercan ALTINÖZ, MD contact

5437446687

ercanaltinöz@gmail.com

Questions about this trial

What is this clinical trial studying?

A study testing UNIPDES - Internet Based Intervention - GUIDED and UNIPDES - Internet Based Intervention - UNGUIDED 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 4 inclusion and 2 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 8 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?

Patient Health Questionnaire-9 (PHQ-9) Turkish Form (time frame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06245200, which also lists 1 linked publication.

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 8 Feb 2024.