Adjunctive Game Intervention for Anhedonia in MDD Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Drug: Escitalopram; Behavioral: Game intervention

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Changsha, China
    • The Second Xiangya Hospital of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central South University
• Investigators: Principal Investigator: Wenbin Guo, Central South University

Study record dates

Study Major Dates

• Study Start (Actual): September 9, 2021
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (Actual): July 26, 2021

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Anhedonia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Serotonin Agents; Selective Serotonin Reuptake Inhibitors; Escitalopram
• Other Study ID Numbers: LYG2021038

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No