Development and Evaluation of an e-Mental Health Program for Depressive Symptoms

April 18, 2026 updated by: Chang Hsiu-Ju

A Digital Approach to Depression: Development and Evaluation of an Electronic Mental Health Program for Depressive Symptoms

This randomized controlled trial evaluates the effectiveness of an electronic mental health program (e-MHP) in reducing depressive symptoms among adults. The study also compares outcomes between clinical and nonclinical populations.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Major depressive disorder (MDD) is a prevalent and chronic mental health condition associated with substantial morbidity, including disability, suicide risk, and socioeconomic burden. Despite the availability of effective treatments, access to care remains limited due to barriers such as cost, stigma, long wait times, and shortages of mental health professionals. These challenges are particularly pronounced in underserved and remote populations.

Digital mental health interventions, including internet- and mobile-based programs, have emerged as scalable and accessible approaches to address these gaps. Evidence suggests that such interventions, particularly those based on cognitive behavioral therapy (CBT), can achieve outcomes comparable to traditional face-to-face treatments while offering advantages in cost-effectiveness and accessibility. However, issues such as user engagement, adherence, and variability in effectiveness across populations remain important concerns.

The present study aims to evaluate the effectiveness of an electronic mental health program (e-MHP) designed to reduce depressive symptoms and related outcomes, including anhedonia, self-esteem, and suicidal ideation. The intervention integrates components of CBT, health promotion, and positive psychology.

Participants are randomly assigned to either the intervention group, which receives the e-MHP, or a comparison condition. The study includes both clinical participants with depressive symptoms and nonclinical individuals at risk, allowing for comparison of intervention effects across populations with differing symptom severity and care needs.

The primary outcome is a change in depressive symptom severity. Secondary outcomes include changes in anhedonia, global self-esteem, and suicidal ideation. The findings are expected to inform the development and implementation of scalable digital mental health interventions and contribute to evidence-based strategies for depression prevention and treatment across diverse populations.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Taiwan
      • Taipei, Taiwan, Taiwan, 155
        • National Yang Ming Chiao Tung University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria: The inclusion criteria for clinical participants were as follows: being aged 18 to 65 years, receiving a diagnosis of mood disorders (made based on International Classification of Diseases, Tenth Revision codes: F32, F33, F34, F38, or F39), having a PHQ-9 score of 5 to 14, being fluent in Chinese, and having Internet access with basiThe nonclinical group (n = 44) was recruited from 2 universities.

  • The inclusion criteria for nonclinical participants were as follows: being ages 18 to 25 years, being a university student, having a PHQ-9 score of 5 to 14, being fluent in Chinese, and having Internet access with basic digital literacy.

Exclusion Criteria: The exclusion criteria for all participants were as follows: receiving a diagnosis of schizophrenia or bipolar disorder and having active suicidal ideation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Digital mental health program group
A 12-week digital mental health program with nine interactive online modules addressing depression literacy, cognitive reframing, emotional acceptance, behavioral activation, interpersonal skills, relaxation, healthy lifestyle, and positive psychology. Modules (~30 min each) were self-paced, with interactive exercises to reinforce skill use.
Behavioral: digital mental health program
The digital mental health program comprises nine interactive online modules that target knowledge of depression, cognitive reframing, emotional acceptance, behavioral activation, interpersonal skills, relaxation, a healthy lifestyle, and positive psychology.
No Intervention: control group
Participants did not receive the digital mental health program and continued their usual daily routines without additional intervention.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Depression Severity
Time Frame: From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.

Depression severity will be assessed using a standardized depression scale. Scores will be analyzed as continuous variables.

Unit of Measure: Scale score (e.g., 0-27)

Interpretation:

<5 = normal 5-9 = mild 10-14 = moderate 15-19 = moderately severe

≥20 = severe
From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Anhedonia
Time Frame: From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.

Anhedonia will be assessed using a validated anhedonia scale. Scores range from 14 to 56, with higher scores indicating fewer pleasant experiences.

Unit of Measure: Scale score (14-56). Interpretation: Higher scores indicate fewer pleasant experiences.
From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.
Change in Self-Esteem
Time Frame: From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.

Self-esteem will be evaluated using a validated self-esteem scale. Scores range from 4 to 40, with higher scores indicating higher levels of self-esteem.

Unit of Measure: Scale score (4-40). Interpretation: Higher scores indicate higher self-esteem.
From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.
Effectiveness analysis of a digital mental health program intervention on positive and negative suicide ideation.
Time Frame: From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.
The PANSI-PI and PANSI-NSI subscales have a total score range of 0 to 30 and 0 to 40, respectively. Higher scores on the PANSI-PI indicate stronger protective ideation, whereas higher scores on the PANSI-NSI indicate greater suicidal ideation.
From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Chang Hsiu-Ju

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Science and Technology Council, Taiwan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 17, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NYMCTU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share IPD due to privacy concerns, legal restrictions, institutional policies, or no consent from participants.

Our ethics approval or consent form does not allow sharing.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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