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

Not Applicable

Not yet recruiting

• Conditions: Mental Health Issue
• Interventions: Other: UNIPDES - Internet Based Intervention - GUIDED; Other: UNIPDES - Internet Based Intervention - UNGUIDED

• Registration Number: NCT06245200
• Lead Sponsor: Anadolu University

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.

Study Timeline

• Study First Submitted: 2024-01-21
• Study First Submitted QC: 2024-01-29
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-06
• Study First Posted: 2024-02-07
• Last Update Posted: 2024-02-08
• Study Start: 2024-05-01
• Primary Completion: 2024-12-01
• Study Completion: 2025-08-25

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 330

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Guided Internet Based Intervention	UNIPDES - Internet Based Intervention - GUIDED	Participants in this group will use the UNIPDES intervention with guidance support.
Unguided Internet Based Intervention	UNIPDES - Internet Based Intervention - UNGUIDED	Participants in this group will use the UNIPDES intervention without guidance

Primary Outcome Measures

Name	Time	Method
Patient Health Questionnaire-9 (PHQ-9) Turkish Form	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	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	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.

Secondary Outcome Measures

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