UNIPDES- An Internet-Based Transdiagnostic Intervention for College Students' Psychological Symptoms: Evaluation of Its Development, Usability and Effectiveness Study Protocol
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 330
- 主要终点
- Patient Health Questionnaire-9 (PHQ-9) Turkish Form
研究概览
简要总结
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 .
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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;
排除标准
- •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
结局指标
主要结局
Patient Health Questionnaire-9 (PHQ-9) Turkish Form
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- System Usability Scale (SUS-10) Turkish Form: SUS-10(post-test (6 weeks later from pre-test))