Clinical trial NCT05188950: Effectiveness of a CBT Based Mobile Application
Official title: Effectiveness of a Cognitive Behavioral Therapy Based Mobile Application in College Students With Depression Symptoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Symptoms
Keywords: mobile application
cognitive behavioral therapy
depression symptoms
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
Collaborators: name: Yuanpei University of Medical Technology
name: Fooyin University
name: Tajen University
name: Taiwan Nurses Association
First posted: 2022-01-12
Enrollment: 91
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline (1st week) in depressive symptoms on the Tung's Depression Inventory for College Students (TDICS) at Week 4, 8,12.
timeFrame: Baseline(1st week) and 4th week, 8th week,12th week.
measure: Change from Baseline(1st week) in suicide ideation on Concise Mental Health Checklist (CMHC) at Week 4, 8,12.
timeFrame: Baseline(1st week) and 4th week, 8th week,12th week.
Secondary outcomes:
measure: Change from Baseline(1st week) in emotional self-awareness on Emotional Self-Awareness Scale - Revised (ESAS-R) at Week 4, 8,12.
timeFrame: Baseline(1st week) and 4th week, 8th week,12th week.
measure: 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.
timeFrame: Baseline(1st week) and 4th week, 8th week,12th week.
measure: Change from Baseline(1st week) in mHealth literacy on mHealth literacy of app Scale at Week 4, 8,12.
timeFrame: Baseline(1st week) and 4th week, 8th week,12th week.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School of Nursing, College of Medicine, National Taiwan University
Study officials:
affiliation: School of Nursing, College of Medicine, National Taiwan University
name: Meei-Fang Lou, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: