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

NCT06245200 | Not Yet Recruiting

• 2 other identifiers: E-80558721-050.99-2300154653123K895
• Study Type: interventional
• Target: 330
• Locations: 0 countries
• Sites: N/A

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 .

Conditions

Mental Health Issue

Keywords

cognitive behavioral therapy

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  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

  post-test (6 weeks later from pre-test)

Other Outcomes (4)

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

  Pre-test

• Demographic Information Form

  Pre-test

• Module Evaluation

  during the experiment

Study Arms (3)

Guided Internet Based Intervention

EXPERIMENTAL

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

Other: UNIPDES - Internet Based Intervention - GUIDED

Unguided Internet Based Intervention

EXPERIMENTAL

Participants in this group will use the UNIPDES intervention without guidance

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.

Interventions

UNIPDES - Internet Based Intervention - GUIDED 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.

Guided Internet Based Intervention

UNIPDES - Internet Based Intervention - UNGUIDED 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).

Unguided Internet Based Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (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 or mobile device);
• being over the age of 18;

You may not qualify if:

• 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

Sponsors & Collaborators

• Anadolu University: lead
• Eskisehir Osmangazi University: collaborator

Related Publications (1)

• 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.

  PMID: 40191049 DERIVED

Central Study Contacts

ÖMER ÖZER, PH.D.

CONTACT

5437446687; omer_ozer@anadolu.edu.tr

Ali Ercan ALTINÖZ, MD

CONTACT

5437446687; ercanaltinöz@gmail.com

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: January 21, 2024
• First Posted: February 7, 2024
• Study Start: May 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: August 25, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Before the experiment
• Access Criteria: open access journal for everyone and request from PI