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临床试验/NCT05188950
NCT05188950已完成不适用

Effectiveness of a Cognitive Behavioral Therapy Based Mobile Application in College Students With Depression Symptoms

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2021年11月18日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
91
试验地点
1
主要终点
Change from baseline (1st week) in depressive symptoms on the Tung's Depression Inventory for College Students (TDICS) at Week 4, 8,12.

研究概览

简要总结

This research aims to explore the effect of a mobile application designed on the basis of cognitive behavioral therapy on college students suffering from depression in terms of their symptoms, suicidal thoughts, and other relevant variables.

详细描述

Background: College students encounter the transition from adolescence to adulthood, thereby possibly facing various factors causing depression. However, instead of consulting a professional, most college students seek help online or through contacts, or internalize their emotions. The current situation could be due to the low efficiency of depression prevention and the limited consultation provided at campus. While many studies have examined adopting mobile applications in dealing with depression, they have not shown consistent results. The cross-sectional research has been the most common; few randomized controlled trials have been conducted. Hence, much empirical evidence is needed to identify the effect of a mobile application.

Aim: This research aims to explore the effect of a mobile application designed on the basis of cognitive behavioral therapy on college students suffering from depression in terms of their symptoms, suicidal ideation, and other relevant variables.

Methodology: This is a randomized controlled trials study. The participants, aged 20 and above, were recruited from three universities of science and technology of similar nature. All of them suffer from depression symptoms and have used Wi-Fi smartphones. They were randomly assigned to the control group and the treatment group. The treatment group received an intervention involving the participants' use of the mobile application for 12 weeks, at least once a week, 20 minutes per session. The generalized estimating equation was adopted to analyze the results regarding the depression symptoms, suicidal ideation, help-seeking attitudes, emotional self-awareness, and mobile health (mHealth) literacy.

Expected outcomes: The results obtained by tracking the symptoms of depression from the empirical research design conducted on campus will provide a reference to understanding to what extent mobile applications could be an appropriate intervention for college students.

Clinical application: The research findings could provide insights for policymaking in respect of helping a person with depression on campus to better meet college students' needs.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Health Services Research
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • suffer from depression symptoms.
  • aged 20 and above.
  • being able to communicate in Chinese or Taiwanese.
  • used Wi-Fi smartphones.
  • Agree and obtain written consent.
  • In the school term during research.

排除标准

  • Have a full-time job.
  • Who has been diagnosed with bipolar disorder, Asperger syndrome, and schizophrenia.
  • Who have the health conditions associated with visual impairments, auditory impairments, and mobility impairments, that are limited to the use of accessibility mobile applications.

结局指标

主要结局

Change from baseline (1st week) in depressive symptoms on the Tung's Depression Inventory for College Students (TDICS) at Week 4, 8,12.

时间窗: Baseline(1st week) and 4th week, 8th week,12th week.

The Tung's Depression Inventory for College Students (TDICS) is validated. It comprised of 32 items in 4-point Likert-type format and can be completed between 5 to 10 minutes. The scores range from 0 (no depressive) to 96 (high depressive symptoms).

Change from Baseline(1st week) in suicide ideation on Concise Mental Health Checklist (CMHC) at Week 4, 8,12.

时间窗: Baseline(1st week) and 4th week, 8th week,12th week.

The Concise Mental Health Checklist (CMHC) is validated. The scores range from 0 (no suicide ideation) to 9 (high suicide ideation).

次要结局

  • Change from Baseline(1st week) in help-seeking attitudes on Attitudes Toward Seeking Professional Psychological Help Shortened Form (ATSPPH-SF) at Week 4, 8,12.(Baseline(1st week) and 4th week, 8th week,12th week.)
  • Change from Baseline(1st week) in emotional self-awareness on Emotional Self-Awareness Scale - Revised (ESAS-R) at Week 4, 8,12.(Baseline(1st week) and 4th week, 8th week,12th week.)
  • Change from Baseline(1st week) in mHealth literacy on mHealth literacy of app Scale at Week 4, 8,12.(Baseline(1st week) and 4th week, 8th week,12th week.)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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