Digital Cognitive Behavioral Therapy for Depressive Disorders

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06423443
• Other study ID #: ICBT2301
• Status: Recruiting
• Phase: N/A
• Start date: December 20, 2023
• Est. completion date: December 30, 2025

Study information

• Verified date: May 2024
• Source: Adai Technology (Beijing) Co., Ltd.
• Contact: Liqun Zhang
• Phone: 010-85795371
• Email: zhangliqun[@]adai-tech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 146
• Est. completion date: December 30, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Digital Cognitive Behavioral Therapy
digital cognitive behavioral therapy app
• Health Education
traditional on-line health education app

Drug:
• TAU
treatment as usual

Locations

Country	Name	City	State
China	West China Hospital	Chengdu	Sichuang

Sponsors (1)

Lead Sponsor	Collaborator
Adai Technology (Beijing) Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PHQ-9 (Patient Health Questionnaire-9)	PHQ-9 Score Range: 0 (best outcome) to 27 (worst outcome); higher scores indicate more severe depression symptoms.	baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months
Secondary	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.	baseline and weekly assessments during the treatment period, assessed up to 8 weeks, and follow-ups at 4 weeks, 12 weeks, and 6 months
Secondary	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).	baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Secondary	Rumination Response Scale (RRS)	Score Range: 22 (best outcome) to 88 (worst outcome) Higher scores indicate higher levels of rumination.	baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
Secondary	Pittsburgh Sleep Quality Index (PSQI)	Score Range: 0 (best outcome) to 21 (worst outcome) Higher scores indicate poorer sleep quality.	baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months