Mental Health Issue
Conditions
Keywords
cognitive behavioral therapy
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.
Interventions
OTHERUNIPDES - 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.
OTHERUNIPDES - 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).
Sponsors
Eskisehir Osmangazi University
Anadolu University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Attitudes Toward Internet-Based Interventions Scale (ETAM) Turkish Form | 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. |
| User Experience on Program Effectiveness | post-test (6 weeks later from pre-test) | Refers to qualitative interviews to be conducted. Interviews will be evaluated by content analysis. |
| Module Evaluation | 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. |
| Demographic Information Form | Pre-test | gather information about the demographics of the participants, including their age, gender, and history of psychiatric treatment/help. |
Contacts
Primary ContactÖMER ÖZER, PH.D.
Backup ContactAli Ercan ALTINÖZ, MD
Outcome results
None listed