Adjunctive Game Intervention for Anhedonia in MDD Patients

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04977232
• Other study ID #: LYG2021038
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: December 2022

Study information

• Verified date: July 2022
• Source: Central South University
• Contact: Wenbin Guo
• Phone: +8613875936768
• Email: guowenbin76[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Anhedonia
• Depression

Intervention

Drug:
• Escitalopram
Selective serotonin reuptake inhibitors (SSRI) were most commonly used first line pharmacotherapy for depression.

Behavioral:
• Game intervention
Participants will be instructed to play the commercial video game for about 30-60 minutes at least three times per week.

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	The Stroop test	Pre-post assessment of cognitive function via the Stroop test.	From baseline to 8 weeks
Secondary	Wisconsin Card Sorting Test (WCST)	Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST).	From baseline to 8 weeks
Secondary	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
Secondary	Magnetic Resonance Imaging data	Whole brain Magnetic Resonance Imaging.	From baseline to 8 weeks