Digital Cognitive Behavioral Therapy for Depressive Disorders

Adai Technology

Status: Enrolling

Conditions: Depression; Anxiety

Treatments: Behavioral: Digital Cognitive Behavioral Therapy; Behavioral: Health Education; Drug: TAU

Study type: Interventional

Funder types: Other

Identifiers

NCT06423443

ICBT2301

Details and patient eligibility

About

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.

Enrollment: 146 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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146 participants in 2 patient groups

Digital Cognitive Behavioral Therapy

Experimental group

Treatment:

Drug: TAU

Behavioral: Digital Cognitive Behavioral Therapy

Health Education

Active Comparator group

Treatment:

Behavioral: Health Education

Drug: TAU