- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07397299
Evaluating The Impact of A Mental Health App on Depression and Resilience Among Medical Students
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:
- 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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Kuala Lumpur
-
Cheras, Kuala Lumpur, Malaysia
- Fakulti Perubatan, Universiti Kebangsaan Malaysia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Participants in the intervention group will receive immediate full access to the mental health app services during the study period.
|
Name of the mental health app - Intellect: Create A Better You
|
|
Other: Control Group
Participants in the control group will receive basic, without full access to the mental health app services during the study period (active control).
|
Name of mental health app - Intellect: Create a Better You
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline and 3 months
|
|
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.
|
Baseline and 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Anxiety
Time Frame: 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.
|
Baseline and 3 months
|
|
Self-esteem
Time Frame: 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.
|
Baseline and 3 months
|
|
Subjective wellbeing
Time Frame: 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.
|
Baseline and 3 months
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- JEP-2025-884
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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