Internet-Based Interventions for MDD

September 21, 2021 updated by: Si Tianmei, Peking University

Effectiveness of Internet-Based Interventions for Treatment Compliance and Outcomes of Major Depressive Disorder

The acute and remission depression patients of 18-65 years old were recruited. At the time of enrollment, the demographic, symptomatic, neuropsychological and medication adherence data was collected. After the completion of the baseline assessment and examination, the patients were given antidepressant treatment or antidepressant treatment combined with Internet-based interventions. Clinical evaluation was performed at 1, 3 months (acute patients) and 6, 12 months (remission patients) after treatment, including the medication adherence, therapeutic efficacy, recurrence rate and functional rehabilitation. Through above work, this research is expected to provide clinicians with a set of Internet generalized technologies to improve the compliance and clinical outcomes of patients with depression, and to provide patients with treatment and management of the entire disease cycle.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

440

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 Contact Backup

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Yunai Su
        • Contact:
          • Yunai Su

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

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 18-65 years old, acute (HAMD17 > 17) and remission (HAMD17 < 8) depression

Exclusion Criteria:

  • other mental illnesses, serious somatic illnesses

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: antidepressant treatment
recieve antidepressant treatment
Drug: antidepressant treatment
depression recieve antidepressant treatment
EXPERIMENTAL: antidepressant treatment combined with Internet-based interventions
recieve antidepressant treatment combined with Internet-based interventions
Other: antidepressant treatment combined with Internet-based interventions
depression recieve antidepressant treatment combined with Internet-based interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HAMD17 reduction ratio
Time Frame: 3 months
The difference of HAMD17 reduction ratio between the two groups was compared
3 months
recurrence rate
Time Frame: 12 months
The difference of recurrence rate between the two groups was compared
12 months

Collaborators and Investigators

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

Sponsor

Peking University

Investigators

  • Principal Investigator: Tianmei Si, PhD, Institute of Mental Health, Peking University

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)

September 1, 2021

Primary Completion (ANTICIPATED)

December 31, 2022

Study Completion (ANTICIPATED)

June 30, 2023

Study Registration Dates

First Submitted

December 21, 2020

First Submitted That Met QC Criteria

December 21, 2020

First Posted (ACTUAL)

December 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

September 22, 2021

Last Update Submitted That Met QC Criteria

September 21, 2021

Last Verified

September 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SF2020-2-4113

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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