ISRCTN ISRCTN47792756
DOI https://doi.org/10.1186/ISRCTN47792756
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
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

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

Study website

Contact information

Mr Yonas Deressa Guracho
Public, Scientific, Principal Investigator

76/7 Northfield Ave
Gwynneville
2500
Australia

ORCiD logoORCID ID 0000-0001-8848-9370
Phone +61 (0)451712838
Email ydg487@uowmail.edu.au

Study information

Study designUsability test, preliminary pre- and post-test design
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Home
Study typeOther, Efficacy
Scientific titleUsability evaluation and preliminary efficacy of mobile mental health solution apps in low-income settings: pre- and post-trial
Study objectivesTo 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) studiedDepression and anxiety
InterventionInterventions 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 typeDevice
Pharmaceutical study type(s)Not Applicable
PhasePhase I
Drug / device / biological / vaccine name(s)Mobile Mental Health app usability test
Primary outcome measure1. 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
2. Depression, anxiety, and stress assessed using the Depression Anxiety Stress Scales – Short Form (DASS-21) scale before and after the intervention
Secondary outcome measuresMental health knowledge evaluated using a 20-item mental health knowledge questionnaire before and after the intervention
Overall study start date10/01/2025
Completion date20/06/2025

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit20 Years
Upper age limit45 Years
SexBoth
Target number of participants40
Total final enrolment40
Key inclusion criteria1. 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 criteria1. 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 enrolment10/05/2025
Date of final enrolment10/06/2025

Locations

Countries of recruitment

  • Ethiopia

Study participating centre

Felege Hiwot Comprehensive Specialized Hospital
Shmbit Kebele 13
Bahir Dar
47
Ethiopia

Sponsor information

University of Wollongong
University/education

University of Wollongong
Wollongong
2522
Australia

Phone +61 (0)2 4221 3386
Email yguracho@uow.edu.au
Website https://www.uow.edu.au
ROR logo "ROR" https://ror.org/00jtmb277

Funders

Funder type

University/education

University of Wollongong
Private sector organisation / Universities (academic only)
Alternative name(s)
UOW
Location
Australia

Results and Publications

Intention to publish date08/11/2025
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryData sharing statement to be made available at a later date
Publication and dissemination planWill be presented at conferences
IPD sharing planThe data-sharing plans for the current study are unknown and will be made available at a later date

Editorial Notes

20/08/2025: Study's existence confirmed by the University of Wollongong Human Research Ethics Committee.