Digital Cognitive Behavioral Therapy for Depressive Disorders

NCT ID: NCT06423443

Last Updated: 2024-05-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

146 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-20

Study Completion Date

2025-12-30

Brief Summary

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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.

Detailed Description

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Conditions

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Depression Anxiety

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Digital Cognitive Behavioral Therapy

Group Type EXPERIMENTAL

Digital Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

digital cognitive behavioral therapy app

TAU

Intervention Type DRUG

treatment as usual

Health Education

Group Type ACTIVE_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

traditional on-line health education app

TAU

Intervention Type DRUG

treatment as usual

Interventions

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Digital Cognitive Behavioral Therapy

digital cognitive behavioral therapy app

Intervention Type BEHAVIORAL

Health Education

traditional on-line health education app

Intervention Type BEHAVIORAL

TAU

treatment as usual

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Adai Technology (Beijing) Co., Ltd.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West China Hospital

Chengdu, Sichuang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Liqun Zhang

Role: CONTACT

010-85795371

Facility Contacts

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Liqun Zhang

Role: primary

Other Identifiers

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ICBT2301

Identifier Type: -

Identifier Source: org_study_id

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