Evaluating the Effectiveness of an Online Cognitive Behavioral Therapy Program for University Students With Depression and/or Anxiety: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
- 试验地点
- 3
- 主要终点
- Anxiety
研究概览
简要总结
The goal of this clinical trial is to learn if an Internet-based self-help program called VIVIM can help university students with depression and/or anxiety. The main question investigadors want to answer is:
* Does the VIVIM program help participants to feel less depressed and/or anxious? The investigators will compare the VIVIM program with the usual psychological support that university counselling services offer to students.
Participants will:
- Be randomly assigned to either use the VIVIM program or receive usual help from university's counselling service.
- Fill out online questionnaires three times: at the beginning, 10 weeks and 6 months after being assigned either the VIVIM program or usual care.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •To be enrolled as an undergraduate or postgraduate at of the participating Spanish universities.
- •To report at least moderate symptoms of depression (PHQ>o= 10) and/or anxiety (GAD-7>o= 10).
排除标准
- •To self-report having been diagnosed with bipolar and/or psychotic disorder.
- •To report to be currently receiving psychotherapy/counselling and/or pharmacological treatment for emotional problems.
- •To be unable to read, speak or understand Spanish.
- •To be at risk of suicide.
研究组 & 干预措施
Internet-based CBT program
This 10-week program consists of 10 modules. Throughout the program, participants progress at their own pace. They have the opportunity to attend two individual support sessions (at the beginning and midway through the program) as well as in weekly group support designed to address questions and reinforce learning. These sessions are conducted via videoconference. Participants also receive weekly automated email remainders and can contact the team via email at any time.
This program is an adaptation of Overcoming Low mood and Depresion: A Five Areas Approach.
干预措施: VIVIM (Viure la Vida al Màxim/Vivir la Vida al Máximo) (Behavioral)
Treatment as usual
Treatment as usual involves referral to the counseling service offered by the university to its students.
干预措施: Counseling (Other)
结局指标
主要结局
Anxiety
时间窗: From enrollment to 6 months after being randomized
The Generalized Anxiety Disorder \[GAD-7\] will be used. The total score ranges from 0-21, with a higher score indicating higher symptoms severity
Depression
时间窗: From enrollment to 6 months after being randomized
The Patient Health Questionnaire-9 item \[PHQ-9\] will be used. The total score ranges from 0 to 27, with a higher score indicating a higher symptom severity
次要结局
- Functional impairment(From enrollment to 6 months after being randomized)
- Mental well-being(From enrollment to 6 months after being randomized)
- Resilience(From enrollment to 6 months after being randomized)
研究者
Anna Huguet
Co-Principal investigator
University Rovira i Virgili