Depressive SymptomsNCT07544758
Development and Evaluation of an e-Mental Health Program for Depressive Symptoms
A study testing digital mental health program in people with Depressive Symptoms, run by Chang Hsiu-Ju at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- digital mental health program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 May 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Depressive Symptoms
- Being tested
- digital mental health program
- Keywords
- Depressive Symptoms, e-Mental Health, suicide prevention
- Medical subject headings
- Depression, Suicide Prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
digital mental health programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Digital mental health program group | Experimental | 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. Receives: Behavioral: digital mental health program |
| control group | No intervention | Participants did not receive the digital mental health program and continued their usual daily routines without additional intervention. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression Severity
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
Measured: From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start1 May 2023
- Primary completion31 Jan 2024
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Hsiu-Ju
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Sponsor-investigator, Chang Hsiu-Ju, National Yang Ming Chiao Tung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07544758
- Sponsor's protocol ID
- NYMCTU
- Status last verified
- Apr 2026
- First submitted
- 17 Aug 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Digital Approach to Depression: Development and Evaluation of an Electronic Mental Health Program for Depressive Symptoms
- ClinicalTrials.gov ID
- NCT07544758
- Acronym / sponsor ID
- NYMCTU
- Conditions
- Depressive Symptoms
- Keywords
- Depressive Symptoms, e-Mental Health, suicide prevention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chang Hsiu-JuUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- 1 May 2023 (actual)
- Primary completion
- 31 Jan 2024 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 22 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Digital mental health program group | Experimental | Behavioral: digital mental health programA 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. |
| control group | No intervention | –Participants did not receive the digital mental health program and continued their usual daily routines without additional intervention. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| digital mental health programThe 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. | Behavioural | Digital mental health program group |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing digital mental health program in people with Depressive Symptoms, run by Chang Hsiu-Ju at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.