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Efficacy, Safety, and Acceptability of Internet-based Cognitive Behavioral Therapy

NCT05554289 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 315

Last updated 2025-09-24

No results posted yet for this study

Summary

This is a prospective, randomized, multicenter, double-blind, placebo-controlled phase III trial evaluating the efficacy and safety of WL-iCBT - a smartphone-based digital therapeutic combining cognitive behavioral therapy and attention bias modification. The study enrolls 315 participants aged 18-60 with mild-to-moderate MDD (MADRS score 18-30) across 11 clinical centers in China. Participants will be randomized to receive either active WL-iCBT or placebo software for 8 weeks, followed by a 26-week observational extension phase. Primary endpoint is change in MADRS score from baseline to Week 8. Secondary endpoints include treatment response rate, remission rate, anxiety symptoms (HAMA), functional impairment (SDS), and cognitive function (PDQ-D), and Clinical Global Impression rating scale (CGI). Safety monitoring includes AE/SAE recording and device deficiency assessment. Acceptability will be assessed by device performance evaluation.

Conditions

Interventions

DEVICE

Depression Auxiliary Intervention Treatment Software (WL-iCBT)

The Depression Auxiliary Intervention Treatment Software (WL-iCBT) is a mobile application for smartphones that delivers cognitive behavioral therapy (CBT) and cognitive bias modification (CBM) through structured interactive multimedia methods, including animations, videos, audio, and interactive exercises.

DEVICE

Placebo Control Software (WL-iHE)

The placebo control software (WL-iHE) is a mobile application that mimics the appearance and usage pattern of the active intervention software but lacks the therapeutic cognitive behavioral therapy components. The software has a similar user interface and time requirements, with participants using it once daily for 10-15 minutes, completing a total of 56 sessions over the 8-week treatment period. Unlike the active intervention, the placebo software does not deliver structured cognitive behavioral therapy content or cognitive bias modification training, instead providing general health education information without specific depression treatment techniques.

Sponsors & Collaborators

  • Adai Technology (Beijing) Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-21
Primary Completion
2024-03-15
Completion
2024-10-25

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05554289 on ClinicalTrials.gov