Adjunctive Game Intervention for Anhedonia in MDD Patients

Sponsor
Central South University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04977232
Collaborator
(none)
50
1
2
14.7
3.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Game Intervention as Adjunct Therapy for Anhedonia in Patients With Major Depressive Disorder
Actual Study Start Date :
Sep 9, 2021
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. Snaith-Hamilton-Pleasure Scale (SHAPES) [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.

    2. Temporal Experience of Pleasure Scale (TEPS) [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.

    3. Hamilton Depression Rating scale (HAMD) [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.

    Secondary Outcome Measures

    1. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) [From baseline to 8 weeks]

      Pre-post assessment of cognitive function via Repeatable Battery for the Assessment of Neuropsychological Status (RBANS).

    2. The Stroop test [From baseline to 8 weeks]

      Pre-post assessment of cognitive function via the Stroop test.

    3. Wisconsin Card Sorting Test (WCST) [From baseline to 8 weeks]

      Pre-post assessment of cognitive function via Wisconsin Card Sorting Test (WCST).

    4. Rumination Responses Scale [From baseline to 8 weeks]

      Pre-post assessment of rumination via Rumination Responses Scale. Raw score range is 22-88. Higher scores indicate worse outcomes.

    5. Magnetic Resonance Imaging data [From baseline to 8 weeks]

      Whole brain Magnetic Resonance Imaging.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 The Second Xiangya Hospital of Central South University Changsha China

    Sponsors and Collaborators

    • Central South University

    Investigators

    • Principal Investigator: Wenbin Guo, Central South University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Guo Wenbin, Professor of Psychiatry Department of Psychiatry of the Second Xiangya Hospital, Central South University, Central South University
    ClinicalTrials.gov Identifier:
    NCT04977232
    Other Study ID Numbers:
    • LYG2021038
    First Posted:
    Jul 26, 2021
    Last Update Posted:
    Jul 21, 2022
    Last Verified:
    Jul 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 21, 2022