Game-Based Digital Intervention for Relieving Depression and Anxiety Symptoms
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 223
- Locations
- 1
- Primary Endpoint
- GAD7 Response
Study Overview
Brief Summary
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •age between 18 and 60 years;
- •having a PHQ-9 score or a GAD-7 score upon enrollment;
- •being able to operate a smartphone fluently;
- •having normal vision after correction
Exclusion Criteria
- •clinical diagnoses of severe psychiatric conditions such as schizophrenia or bipolar disorder;
- •at high risk of suicide or self-harm;
- •having significant cognitive impairments;
- •active substance abuse or dependence;
- •currently undergoing other psychological or pharmacological treatments for depression or anxiety;
- •pregnant individuals or those with postpartum depression, and those with serious physical health conditions that could impact mental health.
Outcomes
Primary Outcomes
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
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
Secondary Outcomes
No secondary outcomes reported