NCT07397299

Brief 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for not_applicable

Timeline
2mo left

Started Feb 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress61%
Feb 2026Jun 2026

First Submitted

Initial submission to the registry

February 2, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 9, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

February 11, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2026

Last Updated

February 13, 2026

Status Verified

February 1, 2026

Enrollment Period

5 months

First QC Date

February 2, 2026

Last Update Submit

February 10, 2026

Conditions

Depression - Major Depressive DisorderResilience

Keywords

impact of mental health appdepressionresiliencemedical studentseffectiveness of mental health appdigital mental health intervention

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    Baseline and 3 months

Secondary Outcomes (3)

  • Anxiety

    Baseline and 3 months

  • Self-esteem

    Baseline and 3 months

  • Subjective wellbeing

    Baseline and 3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Participants in the intervention group will receive immediate full access to the mental health app services during the study period.

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).

Behavioral: Basic digital mental health intervention

Interventions

Full digital mental health interventionBEHAVIORAL

Name of the mental health app - Intellect: Create A Better You

Intervention Group
Basic digital mental health interventionBEHAVIORAL

Name of mental health app - Intellect: Create a Better You

Control Group

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • Does not consent to study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fakulti Perubatan, Universiti Kebangsaan Malaysia

Cheras, Kuala Lumpur, Malaysia

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: A randomized controlled, prospective, parallel-group study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator; Psychiatrist

Study Record Dates

First Submitted

February 2, 2026

First Posted

February 9, 2026

Study Start

February 11, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Last Updated

February 13, 2026

Record last verified: 2026-02

Locations

MY(1)