NCT05188950

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
91

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2021

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 12, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 17, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 17, 2022

Completed
Last Updated

January 20, 2023

Status Verified

October 1, 2021

Enrollment Period

6 months

First QC Date

December 8, 2021

Last Update Submit

January 19, 2023

Conditions

Depressive Symptoms

Keywords

mobile applicationcognitive behavioral therapydepression symptoms

Outcome Measures

Primary Outcomes (2)

  • 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).

    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).

    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.

    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.

    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.

Study Arms (2)

treatment group

EXPERIMENTAL

The intervention involved the participants' use of the mobile application.

Device: depression screening test App

control group

NO INTERVENTION

As usual.

Interventions

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.

treatment group

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Nursing, College of Medicine, National Taiwan University

Taipei, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 39692262DERIVED

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Meei-Fang Lou, Ph.D.

    School of Nursing, College of Medicine, National Taiwan University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

January 12, 2022

Study Start

November 18, 2021

Primary Completion

May 17, 2022

Study Completion

May 17, 2022

Last Updated

January 20, 2023

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data.

Locations

TW(1)