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

Mental Health Issue Clinical Trial

— UNIPDES  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06245200
• Other study ID #: E-80558721-050.99-2300154653
• Secondary ID: 123K895
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2024
• Est. completion date: August 25, 2025

Study information

• Verified date: February 2024
• Source: Anadolu University
• Contact: ÖMER ÖZER, PH.D.
• Phone: 5437446687
• Email: omer_ozer[@]anadolu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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 .

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 330
• Est. completion date: August 25, 2025
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Health Issue

Intervention

Other:
• 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.
• 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).

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Anadolu University	Eskisehir Osmangazi University

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form	ETAM will use people's opinions/attitudes about internet-based interventions. It consists of 16 items. It is defined as a five-point Likert scale. A high score indicates a positive attitude towards internet-based interventions.	Pre-test
Other	Demographic Information Form	gather information about the demographics of the participants, including their age, gender, and history of psychiatric treatment/help.	Pre-test
Other	Module Evaluation	At the end of each module, users will be asked a single question to evaluate the module. With this measurement, it will be assessed how functional the participants find the module. It is scored between 0-10, with a high score indicating that the module is considered functional.	during the experiment
Other	User Experience on Program Effectiveness	Refers to qualitative interviews to be conducted. Interviews will be evaluated by content analysis.	post-test (6 weeks later from pre-test)
Primary	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)
Primary	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)
Primary	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	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.	post-test (6 weeks later from pre-test)