Digital Cognitive Behavioral Therapy for Depressive Disorders

Adai Technology (Beijing) Co., Ltd.146 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

146

Conditions

Depression Anxiety

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

Montgomery-Asberg Depression Rating Scale (MADRS)

Score Range: 0 (best outcome) to 60 (worst outcome) Higher scores indicate worse depression symptoms.

Time frame: baseline and immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months

Secondary Outcomes

PHQ-9 (Patient Health Questionnaire-9)

PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms.

Time frame: 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)

GAD-7 Score Range: 0 (best outcome) to 21 (worst outcome); higher scores indicate more severe generalized anxiety symptoms.

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months

Digital Cognitive Behavioral Therapy for Depressive Disorders

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts