Mobile mental health app usability test
| ISRCTN | ISRCTN47792756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47792756 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Protocol serial number | Nil known |
| Sponsor | University of Wollongong |
| Funder | University of Wollongong |
- Submission date
- 17/08/2025
- Registration date
- 20/08/2025
- Last edited
- 20/08/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English summary of protocol
Background and study aims
Mobile mental health apps present unique opportunities to democratize mental health care by expanding access to services, especially in underserved populations. However, evidence-based mobile mental health apps developed in the Ethiopian setting are scarce; therefore, this study assesses the feasibility and effectiveness of a mobile mental health solution app, a locally adapted app addressing depression and anxiety. This study aims to determine the feasibility and effectiveness of a newly developed mobile mental health solution app among individuals with depression and anxiety in Ethiopia.
Who can participate?
Patients aged 20 to 45 years with depression and anxiety
What does the study involve?
Participants were requested to complete several tasks, which included:
1. Accessing mental health information (covering concepts like depression, anxiety, and psychiatric emergencies)
2. Self-assessment by answering 21 multiple-choice questions to gauge levels of depression, anxiety, and psychological distress
3. Self-care techniques (such as mindfulness, meditation, progressive muscle relaxation, and breathing exercises)
4. Applying psychological first aid techniques
5. Reviewing mental well-being tips
6. Recording medication details (including type, dosage, and frequency) and setting reminders for medication and appointments
7. Updating their profiles and medication information in the app
8. Tracking and reviewing their symptoms and medication usage
Upon completion of the 4-week usage period, participants were asked to complete a paper-based survey during a scheduled appointment.
What are the possible benefits and risks of participating?
Possible benefits could be gaining insight or being aware of depression and anxiety. Risk could be the time devoted to using the app.
Where is the study run from?
Felege Hiwot Comprehensive Specialized Hospital (Ethiopia)
When is the study starting and how long is it expected to run for?
January 2025 to June 2025
Who is funding the study?
University of Wollongong (Australia)
Who is the main contact?
Yonas Deressa Guracho, ydg487@uowmail.edu.au
Contact information
Public, Scientific, Principal investigator
76/7 Northfield Ave
Gwynneville
2500
Australia
 ORCID ID |
0000-0001-8848-9370 |
|---|---|
| Phone | +61 (0)451712838 |
| ydg487@uowmail.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Usability test, preliminary pre- and post-test design |
| Secondary study design | Non randomised study |
| Scientific title | Usability evaluation and preliminary efficacy of mobile mental health solution apps in low-income settings: pre- and post-trial |
| Study objectives | To determine the usability and efficacy of a newly developed mobile mental health solution app among individuals with depression and anxiety in Ethiopia |
| Ethics approval(s) |
Approved 04/07/2025, University of Wollongong Human Research Ethics Committee (University of Wollongong, Wollongong, 2522, Australia; +61 (0)2 4221 3386; uow-humanethics@uow.edu.au), ref: 2023/122 |
| Health condition(s) or problem(s) studied | Depression and anxiety |
| Intervention | Interventions were conducted for 4 weeks. Participants were requested to complete several tasks, which included: 1. Accessing mental health information (covering concepts like depression, anxiety, and psychiatric emergencies) 2. Self-assessment by answering 21 multiple-choice questions to gauge levels of depression, anxiety, and psychological distress 3. Self-care techniques (such as mindfulness, meditation, progressive muscle relaxation, and breathing exercises) 4. Applying psychological first aid techniques 5. Reviewing mental well-being tips 6. Recording medication details (including type, dosage, and frequency) and setting reminders for medication and appointments 7. Updating their profiles and medication information in the app 8. Tracking and reviewing their symptoms and medication usage Upon completion of the 4-week usage period, participants were asked to complete a paper-based survey during a scheduled appointment. |
| Intervention type | Device |
| Phase | Phase I |
| Drug / device / biological / vaccine name(s) | Mobile Mental Health app usability test |
| Primary outcome measure(s) |
1. Ease of use, satisfaction with the interface and usefulness assessed using the 18-item self-administered Mobile App Usability Questionnaire (MAUQ) at the end of the intervention |
| Key secondary outcome measure(s) |
Mental health knowledge evaluated using a 20-item mental health knowledge questionnaire before and after the intervention |
| Completion date | 20/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 20 Years |
| Upper age limit | 45 Years |
| Sex | All |
| Target sample size at registration | 40 |
| Total final enrolment | 40 |
| Key inclusion criteria | 1. Individuals who self-reported having a diagnosis of major depressive disorder or anxiety disorder. In addition, the Depression Anxiety Stress Scales-21 (DASS-21) was used to assess the level of depression, anxiety, and stress. Therefore, study participants with a mild-moderate level of depression (10-20), anxiety (8-14), or stress (15-25) were included in the study 2. Participants who consented to use the Mobile Mental Health Solution App for 4 weeks 3. Individuals who were receiving follow-up treatment for depression or anxiety during the data collection period 4. Individuals who had at least 3 months of follow-up or had received treatment for at least three visits were included in the study |
| Key exclusion criteria | 1. Individuals who had other mental disorders or comorbidities were excluded from the study. 2. Individuals with a Mini-Mental State Examination questionnaire score of less than 24 were excluded from the study |
| Date of first enrolment | 10/05/2025 |
| Date of final enrolment | 10/06/2025 |
Locations
Countries of recruitment
- Ethiopia
Study participating centre
Bahir Dar
47
Ethiopia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Study website | Study website | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
20/08/2025: Study's existence confirmed by the University of Wollongong Human Research Ethics Committee.
