Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms

March 4, 2024 updated by: Adai Technology (Beijing) Co., Ltd.
Objective: To collect preliminary data and assess the preliminary effectiveness of a game-based digital therapeutics (DTx) intervention for individuals with symptoms of anxiety and depression, and to investigate whether reinforcement learning (RL) can personalize the intervention and enhance effectiveness. Design: Randomized controlled trial with three arms. Setting: Internet-based recruitment and delivery of the intervention. Participants: 223 individuals with symptoms of anxiety and depression, aged between 18 and 50 years. Interventions: Participants were randomly assigned to one of three groups: game-based DTx with RL algorithm (RL algorithm group), game-based DTx without RL algorithm (no algorithm group), and a blank control group. Main Outcomes and Measures: The primary outcomes were reductions in symptoms of anxiety and depression, measured using the Patient Health Questionnaire-9 and Generalized Anxiety Disorder 7-item scales. Response rates and rates of recovery, as well as the impact of demographic variables, were also examined.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

223

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 Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China
        • The First Hospital of China Medical University

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

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. age between 18 and 60 years;
  2. having a PHQ-9 score or a GAD-7 score upon enrollment;
  3. being able to operate a smartphone fluently;
  4. having normal vision after correction

Exclusion Criteria:

  1. clinical diagnoses of severe psychiatric conditions such as schizophrenia or bipolar disorder;
  2. at high risk of suicide or self-harm;
  3. having significant cognitive impairments;
  4. active substance abuse or dependence;
  5. currently undergoing other psychological or pharmacological treatments for depression or anxiety;
  6. pregnant individuals or those with postpartum depression, and those with serious physical health conditions that could impact mental health.

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Blank Control
No intervention
Experimental: RL Algorithm Intervention
Behavioral: Reinforcement learning algorithm powered cognitive and behavioral intervention
Reinforcement learning algorithm powered cognitive and behavioral intervention
Active Comparator: No Algorithm Active Control
Behavioral: cognitive and behavioral intervention
cognitive and behavioral intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
PHQ9 Response
Time Frame: Immeidately after intervention
A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline
Immeidately after intervention
GAD7 Response
Time Frame: Immeidately after intervention
A user is said to responded to the intervention if the PHQ9 score dropped no less than 50% compared to the baseline
Immeidately after intervention

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)

November 1, 2023

Primary Completion (Actual)

January 1, 2024

Study Completion (Actual)

February 1, 2024

Study Registration Dates

First Submitted

March 4, 2024

First Submitted That Met QC Criteria

March 4, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

March 8, 2024

Last Update Submitted That Met QC Criteria

March 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • db2023

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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