Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students

NCT07397299 — Not applicable, Not yet recruiting, 220 participants, National University of Malaysia

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Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students: A Randomized Controlled Study

Registry	NCT07397299
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: triple, treatment
Enrollment	220 (Estimated)
Sponsor	National University of Malaysia (Other)
Conditions	Depression - Major Depressive Disorder, Resilience
Interventions	Full digital mental health intervention, Basic digital mental health intervention (Behavioral)
Dates	start 2026-02-11 (estimated), primary completion 2026-06-30 (estimated), completion 2026-06-30 (estimated), first posted 2026-02-09, last updated 2026-02-13
Locations	1 site in Malaysia

-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.

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.

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+Arms and interventions

Arm	Type	Interventions	Description
Intervention Group	Experimental	Behavioral: Full digital mental health intervention	Participants 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 intervention	Participants in the control group will receive basic, without full access to the mental health app services during the study period (active control).

Full digital mental health intervention (Behavioral): Name of the mental health app - Intellect: Create A Better You
Basic digital mental health intervention (Behavioral): Name of mental health app - Intellect: Create a Better You

+Outcome measures

Primary outcomes

Depressive symptoms [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 [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.

Secondary outcomes

Anxiety [Baseline and 3 months]: 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.
Self-esteem [Baseline and 3 months]: 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.
Subjective wellbeing [Baseline and 3 months]: 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.

+Eligibility

Sex: All, ages: 18 Years to 30 Years, accepts healthy volunteers

Inclusion Criteria:

* Aged 18 to 30;
* Enrolled in medical school (preclinical or clinical years);
* Owns a smartphone;
* Able to read and understand English.

Exclusion Criteria:

* Does not consent to study.

+Locations (1)

Facility	City	Country	Status
Fakulti Perubatan, Universiti Kebangsaan Malaysia	Cheras, Kuala Lumpur	Malaysia