Digital Cognitive Behavioral Therapy for Depressive Disorders

May 22, 2024 updated by: Adai Technology (Beijing) Co., Ltd.

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

146

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Sichuang
      • Chengdu, Sichuang, China
        • Recruiting
        • West China Hospital
        • Contact:
          • Liqun Zhang

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Health Education
Drug: TAU
treatment as usual
Behavioral: Health Education
traditional on-line health education app
Experimental: Digital Cognitive Behavioral Therapy
Behavioral: Digital Cognitive Behavioral Therapy
digital cognitive behavioral therapy app
Drug: TAU
treatment as usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
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
Snaith-Hamilton Pleasure Scale (SHAPS)
Time Frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
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
Rumination Response Scale (RRS)
Time Frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
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
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: baseline, immediately after 8-week intervention, and follow-ups at 4 weeks, 12 weeks, and 6 months
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Adai Technology (Beijing) Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 20, 2023

Primary Completion (Estimated)

June 30, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

May 16, 2024

First Submitted That Met QC Criteria

May 16, 2024

First Posted (Actual)

May 21, 2024

Study Record Updates

Last Update Posted (Actual)

May 24, 2024

Last Update Submitted That Met QC Criteria

May 22, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICBT2301

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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