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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
330

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anadolu University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 25, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 21, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 29, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 7, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 8, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 6, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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