Adjunctive Game Intervention for Anhedonia in MDD Patients

Study Overview
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Brief Summary
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This is a pilot study using game intervention as an adjuvant treatment, to evaluate the effect of the video game on anhedonia and associated functional change of brain in patients with depression. Participants will be randomized to Experimental group receiving a 8-week treatment of antidepressant drugs and game intervention, or Control group receiving a 8-week treatment of antidepressant drugs. Magnetic resonance imaging scanning and assessment of clinical characteristics and cognitive function were conducted before and after the intervention.

Detailed Description
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Depression is a serious mental health problem that affects millions of people globally. Anhedonia, a core symptom of depression, is the loss of pleasure or interest in enjoyable activities. The presence of anhedonia is a risk factor of poor outcome of depression. Although some patients reach remission after treatment, anhedonia still persists as a residual symptom. It is generally believed that the frontal-striatal pathway plays an important role in the reward system of brain in patients with depression. The mechanism of anhedonia is closely related to the function of the brain's reward system dopamine. There have been some research showed benefits of playing video games on brain. Video games can modulate negative emotions and increase positive feelings. Previous studies have confirmed that playing games will activate the release of dopamine in striatum. Dancing Line is a commercial music game. Participants need to change the direction of target according to the music by tapping the screen and manage to finish the routes and get the gems along the route as much as possible. Sometimes the view of participants would change during the game. The game is simple for participants to pick up and there is no need for prior gaming experience. The main purpose of the study is to explore the effect of game as an adjuvant treatment on anhedonia, depressive symptoms, cognitive function and associated functional change of brain in patients with depression.

Official Title
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Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder

Conditions
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Depression

Intervention / Treatment
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* Drug: Escitalopram
* Behavioral: Game intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: a diagnosis of Major Depressive Disorder according to DSM IV or V and validated via Mini International Neuropsychiatric Interview (M.I.N.I.) right handedness capability of understanding and finishing self-rating scales capability of providing informed consent Exclusion Criteria: any other major psychiatric disorders following DSM-5 diagnostic criteria neurological diseases a history of drug abuse suicidal risk pregnancy any contraindication for brain MRI scan.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Escitalopram + game intervention<br>Escitalopram treatment and game intervention are given in combinations for 8 weeks. | Drug: Escitalopram<br>* Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.<br>* Other names: Lexapro;Behavioral: Game intervention<br>* Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.<br>|
| Active Comparator: Escitalopram<br>Escitalopram treatment for 8 weeks | Drug: Escitalopram<br>* Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.<br>* Other names: Lexapro;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Snaith-Hamilton-Pleasure Scale (SHAPES) | Pre-post assessment of anhedonia via the Snaith-Hamilton-Pleasure Scale (SHAPES). Raw score range is 14-56. A higher score indicates a worse outcome. | From baseline to 8 weeks | 
| Temporal Experience of Pleasure Scale (TEPS) | Pre-post assessment of anhedonia via the Temporal Experience of Pleasure Scale (TEPS). Raw score range is 20-120. A lower score indicates a worse outcome. | From baseline to 8 weeks | 
| Hamilton Depression Rating scale (HAMD) | Pre-post assessment of depressive symptoms via Hamilton Depression Rating scale (HAMD). Raw score range is 0-52. Higher scores indicate more severe depression. | From baseline to 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) | Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). | From baseline to 8 weeks | 
| The Stroop test | Pre-post assessment of cognitive function via the Stroop test. | From baseline to 8 weeks | 
| Wisconsin Card Sorting Test (WCST) | Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST). | From baseline to 8 weeks | 
| Rumination Responses Scale | Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes. | From baseline to 8 weeks | 
| Magnetic Resonance Imaging data | Whole brain Magnetic Resonance Imaging. | From baseline to 8 weeks |