Development and effects of a mobile application for self-management of psychological distress among college students
| ISRCTN | ISRCTN12017266 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12017266 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | 2017R1C1B5015986 |
| Sponsor | Catholic University of Korea |
| Funders | National Research Foundation of Korea, Catholic Medical Center Research Foundation |
- Submission date
- 28/06/2021
- Registration date
- 30/06/2021
- Last edited
- 12/04/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
College students transitioning to adulthood are at high risk of psychological distress. Mobile health interventions can help with the self-management of stress and prevent psychological problems in this transition period. This study aims to evaluate the usability and effects of an app for managing psychological distress in college students.
Who can participate?
Students who are aged between 19 and 25 years and currently enrolled in a full bachelor’s degree program at a university in South Korea
What does the study involve?
When using the app, named MEndorphins, participants can monitor their stress levels on a daily basis. After monitoring their stress, participants can identify management strategies suggested by the committee. Based on these, they can plan daily stress management strategies and receive feedback on the extent to which they have been implemented. Additionally, participants can share their experiences with the community of users of the same app and receive feedback on which strategies are effective. After using the app for 7 days, information about the frequency and usage time will be collected directly from the app. Additionally, students can complete online surveys to evaluate the usability and effects of the app on psychological outcomes.
What are the possible benefits and risks of participating?
The participants will not directly benefit but they can learn self-management strategies for reducing their psychological distress by using the app. The study involves minimal risks.
Where is the study run from?
The Catholic University of Korea (South Korea)
When is the study starting and how long is it expected to run for?
March 2020 to June 2020
Who is funding the study?
1. National Research Foundation of Korea (NRF) (South Korea)
2. Catholic Medical Center Research Foundation (South Korea)
Who is the main contact?
Hyunjoo Na
hjna@catholic.ac.kr
Contact information
Scientific
222 Banpodaero
Seochogu
Seoul
06591
Korea, South
 ORCID ID |
0000-0001-6407-7427 |
|---|---|
| Phone | +82 (0)10 4678 0813 |
| hjna@catholic.ac.kr |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Single-group pretest-posttest design |
| Secondary study design | Non randomised study |
| Study type | Participant information sheet |
| Scientific title | Development and effects of a mobile application for self-management of psychological distress among college students: a participatory co-design approach |
| Study objectives | There are significant differences in psychological distress (depression, anxiety, and stress) after using a developed mobile application for 7 days among college students. |
| Ethics approval(s) | Approved 10/03/2020, institutional review board at the Catholic University of Korea Catholic Medical Center (222, Banpodaero, Seochogu, Seoul, 06591, Republic of Korea; +82 (0)2-2258-8213; irbcumc@catholic.ac.kr), ref: MC19FISI0140 |
| Health condition(s) or problem(s) studied | Prevention of psychological distress in college students |
| Intervention | Students use the developed mHealth app for 7 days after providing written informed consent. An mHealth app for psychological distress management was developed using a participatory co-design process. A behavioral activation (BA) approach was used to develop app contents. The BA techniques were applied to the app with the following steps: 1. Monitoring of daily stress levels 2. Planning stress management strategies 3. Feedback for the completion of planned strategies 4. Sharing of users’ feedback When using an app with such components, participants can monitor their stress levels on a daily basis. After monitoring their stress, participants can identify management strategies suggested by the committee. Based on these, they can plan daily stress management strategies and receive feedback on the extent to which they have been implemented. Additionally, participants can share their experiences with the community of users of the same app, MEndorphins, and receive feedback on which strategies are effective. After use of the app is completed, information about the frequency and usage time will be collected directly from the app system. Additionally, students can complete the following online survey measures to evaluate the usability and effects of the developed app on psychological outcomes. |
| Intervention type | Behavioural |
| Primary outcome measure(s) | Psychological distress symptoms of depression, anxiety, and stress measured using the validated Korean version of the depression anxiety stress scale (DASS) at baseline and 7 days after |
| Key secondary outcome measure(s) | 1. The perceived ease of use of the developed app measured using the Korean version of the system usability scale (SUS) after 7 days of app use 2. The perceived quality of the developed app measured using the Korean version of the user version of the mobile application rating scale (uMARS) after 7 days of app use |
| Completion date | 15/06/2020 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 35 |
| Key inclusion criteria | 1. Aged between 19 and 25 years 2. Currently enrolled in a full bachelor’s degree program at a university 3. Using a smartphone with Android (a mobile operating system by Google) 4. Able to use a smartphone without help from others |
| Key exclusion criteria | College students who were not eligible for participation and did not meet the inclusion criteria |
| Date of first enrolment | 04/06/2020 |
| Date of final enrolment | 04/06/2020 |
Locations
Countries of recruitment
- Korea, South
Study participating centre
Seochogu
Seoul
06591
Korea, South
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | All completed data are stored in a private cloud. Only the principal investigator can access and download the de-identified data. All the de-identified questionnaire data were entered and maintained on the researcher’s computer, which has a security lock; these data are accessible only through the use of the principal investigator's password. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
| Preprint results | 19/05/2021 | 12/04/2022 | No | No |
Editorial Notes
12/04/2022: Publication reference added.
29/06/2021: Trial's existence confirmed by the institutional review board at the Catholic University of Korea Catholic Medical Center.
