Depression - Major Depressive DisorderNCT07397299
Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students
A study testing Full digital mental health intervention and Basic digital mental health intervention in people with Depression - Major Depressive Disorder and Resilience, run by National University of Malaysia at 1 site in Malaysia.
Trial summary
This randomized controlled trial aims to determine whether access to a mental health app improves resilience and reduces depressive symptoms among medical students over a three-month period. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Depression - Major Depressive Disorder, Resilience
- What is being tested?
- Full digital mental health intervention and Basic digital mental health intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteMalaysia
- Study dates
- 11 Feb 2026to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged 18 to 30;
- Enrolled in medical school (preclinical or clinical years);
- Owns a smartphone;
- Able to read and understand English.
Who cannot join
- Does not consent to study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Malaysia1 site
Fakulti Perubatan, Universiti Kebangsaan Malaysia
Cheras, Kuala Lumpur
About this study
Official title: Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students: A Randomized Controlled Study
This randomized controlled trial aims to determine whether access to a mental health app improves resilience and reduces depressive symptoms among medical students over a three-month period.
Compared to the control group, researchers hypothesized that medical students in the intervention group are expected to show:
Read more
- Significant reductions in depressive symptoms and greater improvements in resilience after three months of usage.
- Significant reduction in thoughts of self-harm and anxiety, and improvement in self-esteem after three months of usage.
Researchers will compare two groups to evaluate the app's impact on wellbeing:
- Intervention group: Receives immediate full access to the mental health app.
- Control group: Receives basic, without full access to the mental health app.
Participants will explore and experience the various features offered in the mental health app over a three-month period.
- Conditions
- Depression - Major Depressive Disorder, Resilience
- Being tested
- Full digital mental health intervention, Basic digital mental health intervention
- Keywords
- impact of mental health app, depression, resilience, medical students, effectiveness of mental health app, digital mental health intervention
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full digital mental health interventionBehavioural
Name of the mental health app - Intellect: Create A Better You
Basic digital mental health interventionBehavioural
Name of mental health app - Intellect: Create a Better You
| Study group | Role | What they receive |
|---|---|---|
| Intervention Group | Experimental | Participants in the intervention group will receive immediate full access to the mental health app services during the study period. Receives: Behavioral: Full digital mental health intervention |
| Control Group | Other | Participants in the control group will receive basic, without full access to the mental health app services during the study period (active control). Receives: Behavioral: Basic digital mental health intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depressive symptoms
Depressive symptoms will be assessed using the Patient Health Questionnaire-9, developed by Kroenke et al. (2001). This 9-item instrument assesses the frequency of depressive symptoms over the past two weeks. Each item is rated on a 4-point scale, yielding a total severity score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Measured: Baseline and 3 months
Resilience
Resilience will be measured using the Brief Resilience Scale developed by Smith et al. (2008). This 6-item instrument assesses the ability to recover from stress. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 6 to 30, with higher scores indicating greater resilience.
Measured: Baseline and 3 months
Secondary outcomes (3)
Anxiety
Anxiety will be assessed using the Generalized Anxiety Disorder-7 developed by Spitzer et al. (2006). This 7-item instrument assesses generalized anxiety symptoms over the past two weeks. Each item is rated on a 4-point scale, resulting in a total severity score ranging from 0 to 21, with higher total score indicating a greater level of anxiety.
Measured: Baseline and 3 months
Self-esteem
Self-esteem will be measured using the Rosenberg Self-Esteem Scale developed by Rosenberg (1989). This 10-item instrument assesses global self-worth by measuring both positive and negative feelings about the self. Each item is rated on a 4-point Likert scale, yielding a total score ranging from 0 to 30, with higher scores indicating more positive self-esteem.
Measured: Baseline and 3 months
Subjective wellbeing
Subjective wellbeing will be measured using the World Health Organization-Five Well-Being Index. This 5-item instrument assesses the respondent's mental wellbeing over the past two weeks. Each item is rated on a 6-point scale. The raw score is typically multiplied by four to get a percentage score ranging from 0 to 100, with higher scores indicating better mental wellbeing.
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2026
- Study start11 Feb 2026 (estimated)
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depression - Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized controlled, prospective, parallel-group study.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National University of Malaysia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jane Lim Tze Yn, National University of Malaysia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07397299
- Sponsor's protocol ID
- JEP-2025-884
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT07397299
- Acronym / sponsor ID
- JEP-2025-884
- Conditions
- Depression - Major Depressive Disorder, Resilience
- Keywords
- impact of mental health app, depression, resilience, medical students, effectiveness of mental health app, digital mental health intervention
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- National University of MalaysiaUniversity, hospital or other
- Study start
- 11 Feb 2026 (estimated)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 9 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to determine whether access to a mental health app improves resilience and reduces depressive symptoms among medical students over a three-month period.
Compared to the control group, researchers hypothesized that medical students in the intervention group are expected to show:
- Significant reductions in depressive symptoms and greater improvements in resilience after three months of usage.
- Significant reduction in thoughts of self-harm and anxiety, and improvement in self-esteem after three months of usage.
Researchers will compare two groups to evaluate the app's impact on wellbeing:
- Intervention group: Receives immediate full access to the mental health app.
- Control group: Receives basic, without full access to the mental health app.
Participants will explore and experience the various features offered in the mental health app over a three-month period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized controlled, prospective, parallel-group study.
| Arm | Type | Receives |
|---|---|---|
| Intervention Group | Experimental | Behavioral: Full digital mental health interventionParticipants in the intervention group will receive immediate full access to the mental health app services during the study period. |
| Control Group | Other | Behavioral: Basic digital mental health interventionParticipants in the control group will receive basic, without full access to the mental health app services during the study period (active control). |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Aged 18 to 30;
- Enrolled in medical school (preclinical or clinical years);
- Owns a smartphone;
- Able to read and understand English.
Key exclusion criteria (1 listed)
- Does not consent to study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full digital mental health interventionName of the mental health app - Intellect: Create A Better You | Behavioural | Intervention Group |
| Basic digital mental health interventionName of mental health app - Intellect: Create a Better You | Behavioural | Control Group |
Primary outcome
Depressive symptoms
Time frame: Baseline and 3 months
Depressive symptoms will be assessed using the Patient Health Questionnaire-9, developed by Kroenke et al. (2001). This 9-item instrument assesses the frequency of depressive symptoms over the past two weeks. Each item is rated on a 4-point scale, yielding a total severity score ranging from 0 to 27, with higher scores indicating greater severity of depressive symptoms.
Resilience
Time frame: Baseline and 3 months
Resilience will be measured using the Brief Resilience Scale developed by Smith et al. (2008). This 6-item instrument assesses the ability to recover from stress. Each item is rated on a 5-point Likert scale, yielding a total score ranging from 6 to 30, with higher scores indicating greater resilience.
3 secondary outcomes
Anxiety
Time frame: Baseline and 3 months
Self-esteem
Time frame: Baseline and 3 months
Subjective wellbeing
Time frame: Baseline and 3 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full digital mental health intervention and Basic digital mental health intervention in people with Depression - Major Depressive Disorder and Resilience, run by National University of Malaysia at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depressive symptoms (time frame: Baseline and 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026; AzTrials last refreshed its copy on 7 Nov 2026.