Depressive SymptomsNCT05188950
Effectiveness of a CBT Based Mobile Application
A study testing depression screening test App in people with Depressive Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- depression screening test App
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 siteTaiwan
- Study dates
- 18 Nov 2021to 17 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
School of Nursing, College of Medicine, National Taiwan University
Taipei
About this study
Official title: Effectiveness of a Cognitive Behavioral Therapy Based Mobile Application in College Students With Depression Symptoms
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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- depression screening test App
- Keywords
- mobile application, cognitive behavioral therapy, depression symptoms
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
depression screening test AppDevice
The participants' use of the depression screening test App of 6 modules for 12 weeks, at least once a week, 20 minutes per once.
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | The intervention involved the participants' use of the mobile application. Receives: Device: depression screening test App |
| control group | No intervention | As usual. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline (1st week) in depressive symptoms on the Tung's Depression Inventory for College Students (TDICS) at Week 4, 8,12.
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).
Measured: Baseline(1st week) and 4th week, 8th week,12th week.
Change from Baseline(1st week) in suicide ideation on Concise Mental Health Checklist (CMHC) at Week 4, 8,12.
The Concise Mental Health Checklist (CMHC) is validated. The scores range from 0 (no suicide ideation) to 9 (high suicide ideation).
Measured: Baseline(1st week) and 4th week, 8th week,12th week.
Secondary outcomes (3)
Change from Baseline(1st week) in emotional self-awareness on Emotional Self-Awareness Scale - Revised (ESAS-R) at Week 4, 8,12.
Emotional Self-Awareness Scale - Revised (ESAS-R) is validated. The scores range from 0 (no emotional self-awareness) to 84 (high emotional self-awareness).
Measured: Baseline(1st week) and 4th week, 8th week,12th week.
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.
The Attitudes Toward Seeking Professional Psychological Help Shortened Form (ATSPPH-SF) is validated. The scores range from 0 (low help-seeking attitudes) to 30 (positive help-seeking attitudes).
Measured: 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.
The mHealth literacy of app Scale is development by YHL researcher. The purpose of the scale was to develop a screening tool for mHealth literacy of app. Only the treatment group needs to fill this instrument. It is comprised of 8 items in 5-point Likert-type format. The scores range from 8 (low mHealth literacy of app) to 40 (high mHealth literacy of app).
Measured: Baseline(1st week) and 4th week, 8th week,12th week.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start18 Nov 2021
- Primary completion17 May 2022
- Study completion17 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Yuanpei University of Medical Technology, Fooyin University, Tajen University, Taiwan Nurses Association
- Responsible party
- Sponsor
- Investigators
- Meei-Fang Lou, Ph.D., Principal investigator, School of Nursing, College of Medicine, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188950
- Sponsor's protocol ID
- 202108098RINB
- Status last verified
- Oct 2021
- First submitted
- 8 Dec 2021
- Last updated
- 20 Jan 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Publications
Lin YH, Wu CY, Gau BS, Lin CH, Ho HY, Lou MF. Effectiveness Study of a Cultural Adaptation of Cognitive-Behavioural Therapy-Based Application for Depressive Symptoms in College Students: A Randomised Controlled Trial. J Psychiatr Ment Health Nurs. 2025 Jun;32(3):712-722. doi: 10.1111/jpm.13146. Epub 2024 Dec 18.
PubMed 39692262
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Cognitive Behavioral Therapy Based Mobile Application in College Students With Depression Symptoms
- ClinicalTrials.gov ID
- NCT05188950
- Acronym / sponsor ID
- 202108098RINB
- Conditions
- Depressive Symptoms
- Keywords
- mobile application, cognitive behavioral therapy, depression symptoms
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Yuanpei University of Medical Technology, Fooyin University, Tajen University, Taiwan Nurses Association
- Study start
- 18 Nov 2021 (actual)
- Primary completion
- 17 May 2022 (actual)
- Study completion
- 17 May 2022 (actual)
- First posted
- 12 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Device: depression screening test AppThe intervention involved the participants' use of the mobile application. |
| control group | No intervention | –As usual. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| depression screening test AppThe participants' use of the depression screening test App of 6 modules for 12 weeks, at least once a week, 20 minutes per once. | Device | treatment group |
Primary outcome
Change from baseline (1st week) in depressive symptoms on the Tung's Depression Inventory for College Students (TDICS) at Week 4, 8,12.
Time frame: 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.
Time frame: 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).
3 secondary outcomes
Change from Baseline(1st week) in emotional self-awareness on Emotional Self-Awareness Scale - Revised (ESAS-R) at Week 4, 8,12.
Time frame: Baseline(1st week) and 4th week, 8th week,12th week.
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.
Time frame: 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.
Time frame: Baseline(1st week) and 4th week, 8th week,12th week.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Derived from this study: PubMed 39692262Lin YH, Wu CY, Gau BS, Lin CH, Ho HY, Lou MF. Effectiveness Study of a Cultural Adaptation of Cognitive-Behavioural Therapy-Based Application for Depressive Symptoms in College Students: A Randomised Controlled Trial. J Psychiatr Ment Health Nurs. 2025 Jun;32(3):712-722. doi: 10.1111/jpm.13146. Epub 2024 Dec 18.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meei-Fang Lou, Ph.D. principal investigator
School of Nursing, College of Medicine, National Taiwan University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing depression screening test App in people with Depressive Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline (1st week) in depressive symptoms on the Tung's Depression Inventory for College Students (TDICS) at Week 4, 8,12. (time frame: Baseline(1st week) and 4th week, 8th week,12th week.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05188950, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2023.