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Completed

NCT Number: NCT07544758

Development and Evaluation of an e-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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Yang Ming Chiao Tung University

Taipei, Taiwan, 155

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Digital Mental Health Program

Behavioral

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.

Primary outcomes

  1. 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

Other outcomes

  1. 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.

  2. 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.

  3. 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.

Sponsors and collaborators

Lead sponsor

Chang Hsiu-Ju

Other

Collaborators

  • National Science and Technology Council, Taiwan

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Apr 22, 2026
Registry last updated
Apr 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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