Clinical trial NCT06245200: UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms
Official title: UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms: Evaluation of Its Development, Usability and Effectiveness Study Protocol
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Mental Health Issue
Keywords: cognitive behavioral therapy
Lead sponsor: Anadolu University
Sponsor class: OTHER
Collaborators: name: Eskisehir Osmangazi University
First posted: 2024-02-07
Enrollment: 330
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Patient Health Questionnaire-9 (PHQ-9) Turkish Form
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: Generalized Anxiety Disorder-7 (GAD-7) Turkish Form
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
measure: The Brief Adjustment Scale-6 (BASE-6) Turkish Form
timeFrame: Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)
Secondary outcomes:
measure: System Usability Scale (SUS-10) Turkish Form: SUS-10
timeFrame: post-test (6 weeks later from pre-test)
Other outcomes:
measure: Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form
timeFrame: Pre-test
measure: Demographic Information Form
timeFrame: Pre-test
measure: Module Evaluation
timeFrame: during the experiment
measure: User Experience on Program Effectiveness
timeFrame: post-test (6 weeks later from pre-test)
Locations:
Study officials:
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