Clinical trial NCT04977232: Adjunctive Game Intervention for Anhedonia in MDD Patients
Official title: Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Snaith-Hamilton-Pleasure Scale (SHAPES)
timeFrame: From baseline to 8 weeks
measure: Temporal Experience of Pleasure Scale (TEPS)
timeFrame: From baseline to 8 weeks
measure: Hamilton Depression Rating scale (HAMD)
timeFrame: From baseline to 8 weeks
Secondary outcomes:
measure: Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: From baseline to 8 weeks
measure: The Stroop test
timeFrame: From baseline to 8 weeks
measure: Wisconsin Card Sorting Test (WCST)
timeFrame: From baseline to 8 weeks
measure: Rumination Responses Scale
timeFrame: From baseline to 8 weeks
measure: Magnetic Resonance Imaging data
timeFrame: From baseline to 8 weeks
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
Study officials:
affiliation: Central South University
name: Wenbin Guo
role: PRINCIPAL_INVESTIGATOR
References: