Digital therapy combined with medication for depression
Digital Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial
This study is testing if combining digital therapy with medication can help adults with depression feel better compared to just taking medication and doing online mental health education.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 146 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Adai Technology (Beijing) Co., Ltd. Academic / other |
| Locations | 1 site (Chengdu, Sichuang) |
| Trial ID | NCT06423443 on ClinicalTrials.gov |
What this trial studies
This study explores the effectiveness of digital cognitive behavioral therapy (CBT) combined with medication in treating patients with depressive disorders. It aims to determine if this combination can effectively alleviate symptoms of depression compared to medication combined with online mental health education. Participants will engage in the digital therapy alongside their medication for two months, with follow-up assessments to evaluate long-term effects and changes in depressive symptoms. The study will include adults aged 18 to 65 who meet specific diagnostic criteria for depression.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 65 diagnosed with depression who meet the study's inclusion criteria.
Not a fit: Patients with other psychiatric disorders or significant risk of suicide may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could provide a novel and effective treatment option for patients suffering from depression.
How similar studies have performed: Other studies have shown promising results with digital interventions for mental health, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Meets the diagnostic criteria for depression according to the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), without psychotic symptoms, as recurrent outpatient or inpatient. 2. Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization. 3. Age ≥ 18 and ≤ 65 years, regardless of gender. 4. Understands the trial and signs the informed consent form. Exclusion Criteria: 1. Meets criteria for other psychiatric disorders according to the DSM-5, including schizophrenia spectrum disorders, bipolar and related disorders, neurodevelopmental disorders, neurocognitive disorders, or depression due to substance and/or medication or other medical conditions. 2. History of substance and/or alcohol abuse within the past year. 3. Significant risk of suicide (MADRS item 10 score = 4). 4. Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment. 5. Inability to use a smartphone. 6. Deemed unsuitable for participation by the researcher.
Where this trial is running
Chengdu, Sichuang
- West China Hospital — Chengdu, Sichuang, China (Recruiting)
Study contacts
- Study coordinator: Liqun Zhang
- Email: zhangliqun@adai-tech.com
- Phone: 010-85795371
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.