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Randomized Controlled Clinical Trial: Efficacy and Safety Evaluation of a Remote Psychological Intervention System as Adjunctive Therapy in Patients with Mild to Moderate Depression

Randomized Controlled Clinical Trial: Efficacy and Safety Evaluation of a Remote Psychological Intervention System as Adjunctive Therapy in Patients with Mild to Moderate Depression

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500110181
Enrollment
Unknown
Registered
2025-10-09
Start date
2025-10-09
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Interventions

Intervation group:Subjects assigned to the intervention group will receive remote intervention based on cognitive psychotherapy, with an intervention period of 28 days. Subjects are required to comple
Control group:Subjects assigned to the control group will only receive remote intervention based on popular - science videos or texts. The intervention period is 28 days. Subjects are required to comp

Sponsors

The Clinical Hospital of Chengdu Brain Science Institute
Lead Sponsor

Eligibility

Sex/Gender
All
Age
16 Years to 40 Years

Inclusion criteria

Inclusion criteria: 1.Patients voluntarily participate in the trial and provide written informed consent. 2.Aged 16 to 40 years (inclusive), any gender. 3.Meet the DSM-5 diagnostic criteria for Major Depressive Disorder (MDD), confirmed by the M.I.N.I. 7.0.2 interview; experiencing a single or recurrent episode of mild to moderate severity without psychotic features. 4.A Montgomery-Åsberg Depression Rating Scale (MADRS) total score of =15 at the screening visit. 5.Free of antidepressant medication for at least 2 weeks prior to screening (at least 6 weeks for fluoxetine), and assessed by the study investigator as likely to remain off antidepressant therapy for the duration of the trial. 6.Have attained at least a junior high school level of education, demonstrate the ability to comprehend the rating scale content, and are proficient in using a smartphone.

Exclusion criteria

Exclusion criteria: 1.Concurrent neurological disorders, cardiovascular diseases, organic brain diseases, history of significant head trauma, epilepsy, or other serious systemic medical conditions. 2.Presence of suicidal or self-harming behavior, or a score of >=3 on Item 10 (Suicidal Thoughts) of the Montgomery-Åsberg Depression Rating Scale (MADRS). 3.Other major psychiatric disorders, such as intellectual disability, pervasive developmental disorder, attention-deficit/hyperactivity disorder (ADHD), autism spectrum disorder, conduct disorder, schizophrenia, obsessive-compulsive disorder (OCD), or other neurological and psychiatric conditions. 4.History of alcohol or substance abuse, loss of consciousness, or history of illicit drug use. 5.Participation in an interventional clinical trial within the 3 months prior to screening. 6.Judged by the investigator to be poorly compliant or otherwise unsuitable for participation in the study.

Design outcomes

Primary

MeasureTime frame
Improvement score from baseline on the MDRS score;

Secondary

MeasureTime frame
Reduction rate of total MADRS score;Actual number of treatment days / Scheduled number of treatment days;

Countries

China

Contacts

Public ContactHe Zongling

The Clinical Hospital of Chengdu Brain Science Institute, MOE Key Lab for Neuroinformation, University of Electronic Science and Technology of China, Chengdu, China

hzl_811015@163.com+86 138 8221 6027

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026