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Completed

NCT Number: NCT04977232

Adjunctive Game Intervention for Anhedonia in MDD Patients

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central South University

Changsha, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Escitalopram

Drug

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

Other names: Lexapro

Game intervention

Behavioral

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

Primary outcomes

  1. Snaith-Hamilton-Pleasure Scale (SHAPES)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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 outcomes

  1. Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

    Time frame: 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

    Time frame: From baseline to 8 weeks

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

  3. Wisconsin Card Sorting Test (WCST)

    Time frame: From baseline to 8 weeks

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

  4. Rumination Responses Scale

    Time frame: 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

    Time frame: From baseline to 8 weeks

    Whole brain Magnetic Resonance Imaging.

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jul 26, 2021
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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