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

NCT ID: NCT06245200

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 330 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2025-08-25

Brief 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. There are internet-based guided intervention, internet-based unguided intervention and control group in the study.

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 .

Detailed Description

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. There are internet-based guided intervention, internet-based unguided intervention and control group in the study.

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 .

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Guided Internet Based Intervention

Participants in this group will use the UNIPDES intervention with guidance support.

Group Type: EXPERIMENTAL

UNIPDES - Internet Based Intervention - GUIDED

Intervention Type: OTHER

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.

Unguided Internet Based Intervention

Participants in this group will use the UNIPDES intervention without guidance

Group Type: EXPERIMENTAL

UNIPDES - Internet Based Intervention - UNGUIDED

Intervention Type: OTHER

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).

Waitlist

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

UNIPDES - Internet Based Intervention - GUIDED

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.

Intervention Type: OTHER

UNIPDES - Internet Based Intervention - UNGUIDED

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).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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;

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Eskisehir Osmangazi University

OTHER

Sponsor Role: collaborator

Anadolu University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

ÖMER ÖZER, PH.D.

Role: CONTACT

omer_ozer@anadolu.edu.tr

5437446687

Ali Ercan ALTINÖZ, MD

Role: CONTACT

ercanaltinöz@gmail.com

5437446687

References

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.

Reference Type: DERIVED

PMID: 40191049 (View on PubMed)

Other Identifiers

123K895

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E-80558721-050.99-2300154653

Identifier Type: -

Identifier Source: org_study_id