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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| control group | No Intervention | Participants did not receive the digital mental health program and continued their usual daily routines without additional intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From enrollment to the end of intervention at 12 weeks. Post-test is held at 12 weeks after the intervention. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Anhedonia | 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. |
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.
Exclusion Criteria: The exclusion criteria for all participants were as follows: receiving a diagnosis of schizophrenia or bipolar disorder and having active suicidal ideation.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Yang Ming Chiao Tung University | Taipei | Taiwan | 155 | Taiwan |
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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| ID | Term |
|---|---|
| D003863 | Depression |
| D000092864 | Suicide Prevention |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D013405 | Suicide |
| D016728 | Self-Injurious Behavior |
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| Change in Self-Esteem | 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. | 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. |