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

February 6, 2024 updated by: Anadolu University

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

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 .

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

330

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Guided Internet Based Intervention
Participants in this group will use the UNIPDES intervention with guidance support.
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.
Experimental: Unguided Internet Based Intervention
Participants in this group will use the UNIPDES intervention without guidance
Other: 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).
No Intervention: Waitlist
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Pre-test, post-test (6 weeks later from pre-test), follow up (10 weeks later from pre-test)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
System Usability Scale (SUS-10) Turkish Form: SUS-10
Time Frame: 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.
post-test (6 weeks later from pre-test)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form
Time Frame: Pre-test
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
Demographic Information Form
Time Frame: Pre-test
gather information about the demographics of the participants, including their age, gender, and history of psychiatric treatment/help.
Pre-test
Module Evaluation
Time Frame: during the experiment
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
User Experience on Program Effectiveness
Time Frame: post-test (6 weeks later from pre-test)
Refers to qualitative interviews to be conducted. Interviews will be evaluated by content analysis.
post-test (6 weeks later from pre-test)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Anadolu University

Collaborators

Eskisehir Osmangazi University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

May 1, 2024

Primary Completion (Estimated)

December 1, 2024

Study Completion (Estimated)

August 25, 2025

Study Registration Dates

First Submitted

January 21, 2024

First Submitted That Met QC Criteria

January 29, 2024

First Posted (Actual)

February 7, 2024

Study Record Updates

Last Update Posted (Actual)

February 8, 2024

Last Update Submitted That Met QC Criteria

February 6, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • E-80558721-050.99-2300154653
  • 123K895 (Other Grant/Funding Number: THE SCIENTIFIC AND TECHNOLOGICAL RESEARCH COUNCIL OF TÜRKİYE)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Informed consent and study protocol will be shared in the academic journal planned to be published. The data will be forwarded to researchers working in this field upon request from the researcher.

IPD Sharing Time Frame

Before the experiment

IPD Sharing Access Criteria

open access journal for everyone and request from PI

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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