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This study aims to explore the effectiveness of digital interventions combined with medication in the treatment of patients with depressive disorders. Its main aim is to answer: Can digital interventions combined with medication effectively alleviate symptoms of depression? The experiment will compare the effects of medication combined with digital interventions to those combined with online mental health education to evaluate their relative effectiveness. Participants will be required to engage with the medication plus digital therapy for a duration of two months, and follow-up assessments will be conducted to evaluate the long-term effects of the treatments and monitor any changes in depressive symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Digital Cognitive Behavioral Therapy | Experimental |
| |
| Health Education | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Digital Cognitive Behavioral Therapy | Behavioral | digital cognitive behavioral therapy app |
|
| Measure | Description | Time Frame |
|---|---|---|
| Montgomery-Asberg Depression Rating Scale (MADRS) | Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms. | baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| PHQ-9 (Patient Health Questionnaire-9) | PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms. | baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months |
| GAD-7 (Generalized Anxiety Disorder-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liqun Zhang | Contact | 010-85795371 | zhangliqun@adai-tech.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| West China Hospital | Recruiting | Chengdu | Sichuang | China |
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| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
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| Health Education | Behavioral | traditional on-line health education app |
|
| TAU | Drug | treatment as usual |
|
GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms. |
| baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months |
| Snaith-Hamilton Pleasure Scale (SHAPS) | Score Range: 14 (best outcome) to 56 (worst outcome) Higher scores indicate greater levels of anhedonia (reduced ability to experience pleasure). | baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months |
| Rumination Response Scale (RRS) | Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination. | baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months |
| Pittsburgh Sleep Quality Index (PSQI) | Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality. | baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months |