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临床试验/NCT04977232
NCT04977232已完成不适用

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

Central South University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2021年9月9日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
1
主要终点
Hamilton Depression Rating scale (HAMD)

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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.

研究组 & 干预措施

Escitalopram + game intervention

Experimental

Escitalopram treatment and game intervention are given in combinations for 8 weeks.

干预措施: Escitalopram (Drug)

Escitalopram + game intervention

Experimental

Escitalopram treatment and game intervention are given in combinations for 8 weeks.

干预措施: Game intervention (Behavioral)

Escitalopram

Active Comparator

Escitalopram treatment for 8 weeks

干预措施: Escitalopram (Drug)

结局指标

主要结局

Hamilton Depression Rating scale (HAMD)

时间窗: From baseline to 8 weeks

Pre-post assessment of depressive symptoms via Hamilton Depression Rating scale (HAMD). Raw score range is 0-52. Higher scores indicate more severe depression.

Temporal Experience of Pleasure Scale (TEPS)

时间窗: From baseline to 8 weeks

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.

Snaith-Hamilton-Pleasure Scale (SHAPES)

时间窗: From baseline to 8 weeks

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.

次要结局

  • The Stroop test(From baseline to 8 weeks)
  • Rumination Responses Scale(From baseline to 8 weeks)
  • Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)(From baseline to 8 weeks)
  • Wisconsin Card Sorting Test (WCST)(From baseline to 8 weeks)
  • Magnetic Resonance Imaging data(From baseline to 8 weeks)

研究者

发起方
Central South University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Guo Wenbin

Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University

Central South University

研究点 (1)

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