## Protocol Section
### Identification Module
**NCT ID:** NCT06423443

**Brief Title:** Digital Cognitive Behavioral Therapy for Depressive Disorders

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

#### Organization Study ID Info
**ID:** ICBT2301
#### Organization
**Class:** OTHER
**Full Name:** Adai Technology (Beijing) Co., Ltd.
### Status Module
#### Completion Date
**Date:** 2025-12-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-24

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-22

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-06-30

**Type:** ESTIMATED

#### Start Date
**Date:** 2023-12-20

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-21
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-16
**Study First Submit QC Date:** 2024-05-16
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Adai Technology (Beijing) Co., Ltd.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**Brief 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.

### Conditions Module

**Conditions:**

- Depression

- Anxiety

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** DOUBLE

**Who Masked:**

- PARTICIPANT

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 146

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Intervention Names:**

- Behavioral: Digital Cognitive Behavioral Therapy

- Drug: TAU

**Label:** Digital Cognitive Behavioral Therapy

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Behavioral: Health Education

- Drug: TAU

**Label:** Health Education

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Digital Cognitive Behavioral Therapy

**Description:** digital cognitive behavioral therapy app

**Name:** Digital Cognitive Behavioral Therapy

**Type:** BEHAVIORAL

#### Intervention 2

**Arm Group Labels:**

- Health Education

**Description:** traditional on-line health education app

**Name:** Health Education

**Type:** BEHAVIORAL

#### Intervention 3

**Arm Group Labels:**

- Digital Cognitive Behavioral Therapy

- Health Education

**Description:** treatment as usual

**Name:** TAU

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

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

**Measure:** Montgomery-Asberg Depression Rating Scale (MADRS)

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

#### Secondary Outcomes

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

**Measure:** PHQ-9 (Patient Health Questionnaire-9)

**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

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

**Measure:** GAD-7 (Generalized Anxiety Disorder-7)

**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

**Description:** Score Range: 14 (best outcome) to 56 (worst outcome) Higher scores indicate greater levels of anhedonia (reduced ability to experience pleasure).

**Measure:** Snaith-Hamilton Pleasure Scale (SHAPS)

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

**Description:** Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination.

**Measure:** Rumination Response Scale (RRS)

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

**Description:** Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality.

**Measure:** Pittsburgh Sleep Quality Index (PSQI)

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

### Eligibility Module

**Eligibility 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.

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** zhangliqun@adai-tech.com

**Name:** Liqun Zhang

**Phone:** 010-85795371

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Chengdu

**Contacts:**

***Contact 1:***

- **Name:** Liqun Zhang

- **Role:** CONTACT

**Country:** China

**Facility:** West China Hospital

**State:** Sichuang

**Status:** RECRUITING

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000019964

- Term: Mood Disorders

- ID: D000001523

- Term: Mental Disorders

### Condition Browse Module - Browse Branches

- Abbrev: BXM

- Name: Behaviors and Mental Disorders

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M7058

- Name: Depression

- Relevance: LOW

- As Found: Unknown

- ID: M4324

- Name: Anxiety Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7061

- Name: Depressive Disorder

- Relevance: HIGH

- As Found: Depressive Disorder

- ID: M21835

- Name: Mood Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M4815

- Name: Mental Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M14473

- Name: Psychotic Disorders

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003866

- Term: Depressive Disorder

### Misc Info Module

- Version Holder: 2024-05-31
