Digital Cognitive Behavioral Therapy for Depressive Disorders

NCT06423443 | Recruiting

• 1 other identifier: ICBT2301
• Study Type: interventional
• Target: 146
• Locations: 1 country
• Sites: 1

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

Depression; Anxiety

Outcome Measures

Primary Outcomes (1)

• Montgomery-Asberg Depression Rating Scale (MADRS)

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

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

Secondary Outcomes (5)

• PHQ-9 (Patient Health Questionnaire-9)

  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)

  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)

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

• Rumination Response Scale (RRS)

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

• Pittsburgh Sleep Quality Index (PSQI)

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

Study Arms (2)

Digital Cognitive Behavioral Therapy

EXPERIMENTAL

Behavioral: Digital Cognitive Behavioral Therapy; Drug: TAU

Health Education

ACTIVE COMPARATOR

Behavioral: Health Education; Drug: TAU

Interventions

Digital Cognitive Behavioral Therapy BEHAVIORAL

digital cognitive behavioral therapy app

Digital Cognitive Behavioral Therapy

Health Education BEHAVIORAL

traditional on-line health education app

Health Education

TAU DRUG

treatment as usual

Digital Cognitive Behavioral Therapy; Health Education

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Adai Technology (Beijing) Co., Ltd.: lead

Study Sites (1)

West China Hospital

Chengdu, Sichuang, China

RECRUITING

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Central Study Contacts

Liqun Zhang

CONTACT

010-85795371; zhangliqun@adai-tech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2024
• First Posted: May 21, 2024
• Study Start: December 20, 2023
• Primary Completion: June 30, 2025
• Study Completion: December 30, 2025
• Last Updated: May 24, 2024

Record last verified: 2024-05

Locations

CN (1)