Adjunctive Game Intervention for Anhedonia in MDD Patients

NCT ID: NCT04977232

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2022-12-31

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.

Conditions

Depression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Escitalopram + game intervention

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

Group Type: EXPERIMENTAL

Escitalopram

Intervention Type: DRUG

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

Game intervention

Intervention Type: BEHAVIORAL

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

Escitalopram

Escitalopram treatment for 8 weeks

Group Type: ACTIVE_COMPARATOR

Escitalopram

Intervention Type: DRUG

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

Interventions

Escitalopram

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

Intervention Type: DRUG

Game intervention

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

Intervention Type: BEHAVIORAL

Other Intervention Names

Lexapro

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Guo Wenbin

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

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Wenbin Guo

Role: PRINCIPAL_INVESTIGATOR

Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, , China

Countries

China

Other Identifiers

LYG2021038

Identifier Type: -

Identifier Source: org_study_id