RecruitingNot ApplicableNCT06423443

Digital Cognitive Behavioral Therapy for Depressive Disorders

Digital Cognitive Behavioral Therapy for Depressive Disorders: A Randomized Controlled Trial

Sponsor

Adai Technology (Beijing) Co., Ltd.

Enrollment

146 participants

Start Date

Dec 20, 2023

Study Type

INTERVENTIONAL

Conditions

Depression Anxiety

Summary

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Inclusion Criteria4

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.
Patients with a Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 22 before randomization.
Age ≥ 18 and ≤ 65 years, regardless of gender.
Understands the trial and signs the informed consent form.

Exclusion Criteria6

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.
History of substance and/or alcohol abuse within the past year.
Significant risk of suicide (MADRS item 10 score = 4).
Difficulty or inability to communicate verbally, understand or follow instructions, or cooperate with treatment and assessment.
Inability to use a smartphone.
Deemed unsuitable for participation by the researcher.