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

Anadolu University0 sites330 target enrollmentMay 1, 2024

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 1, 2024

End Date

August 25, 2025

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Anadolu University

Responsible Party

Sponsor

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

Exclusion Criteria

Not provided

Outcomes

Primary Outcomes

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.