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

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

70

Phase

  • 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

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
Intervention / Treatment
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

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

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

Chang Hsiu-Ju

Collaborators

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)

May 1, 2023

Primary Completion (Actual)

January 31, 2024

Study Completion (Actual)

January 31, 2024

Study Registration Dates

First Submitted

August 17, 2025

First Submitted That Met QC Criteria

April 18, 2026

First Posted (Actual)

April 22, 2026

Study Record Updates

Last Update Posted (Actual)

April 22, 2026

Last Update Submitted That Met QC Criteria

April 18, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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