Effectiveness of a CBT Based Mobile Application

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05188950
Collaborator
Yuanpei University of Medical Technology (Other), Fooyin University (Other), Tajen University (Other), Taiwan Nurses Association (Other)
90
1
2
23.2
3.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: depression screening test App
N/A

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

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Health Services Research
Official Title:
Effectiveness of a Cognitive Behavioral Therapy Based Mobile Application in College Students With Depression Symptoms
Actual Study Start Date :
Nov 18, 2021
Anticipated Primary Completion Date :
Oct 26, 2023
Anticipated Study Completion Date :
Oct 26, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment group

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

Device: depression screening test App
The participants' use of the depression screening test App of 6 modules for 12 weeks, at least once a week, 20 minutes per once.

No Intervention: control group

As usual.

Outcome Measures

Primary Outcome Measures

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

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

Secondary Outcome Measures

  1. 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.]

    Emotional Self-Awareness Scale - Revised (ESAS-R) is validated. The scores range from 0 (no emotional self-awareness) to 84 (high emotional self-awareness).

  2. 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.]

    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).

  3. 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.]

    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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 School of Nursing, College of Medicine, National Taiwan University Taipei Taiwan

Sponsors and Collaborators

  • National Taiwan University Hospital
  • Yuanpei University of Medical Technology
  • Fooyin University
  • Tajen University
  • Taiwan Nurses Association

Investigators

  • Principal Investigator: Meei-Fang Lou, Ph.D., School of Nursing, College of Medicine, National Taiwan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT05188950
Other Study ID Numbers:
  • 202108098RINB
First Posted:
Jan 12, 2022
Last Update Posted:
Jan 12, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by National Taiwan University Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 12, 2022