Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study

Overview

The purpose of this study is to investigate the short-term effects of mindfulness-based training in individuals suffering from major depressive disorder (MDD) as assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: January 2020

Interventions

  • Behavioral: Mindfulness-Based Training
    • Mindfulness-Based Training comprises of mindful walking, body scanning and raisin meditation exercise. Participants will receive a guided session of mindfulness meditation, and will be asked to finish at least 30 minutes of Mindfulness-Based Training every day as homework as well as keep a diary describing their experiences and reflections. An expert in mindfulness practice will offer feedback and answer any questions online.
  • Behavioral: Relaxation Training
    • Participants will listen to a 15-minute Relaxation Training tape twice a day.

Arms, Groups and Cohorts

  • Experimental: Mindfulness-Based Training
    • Participants in the Mindfulness-Based Training arm will receive 2 weeks of Mindfulness-Based Training for at least 30 minutes every day.
  • Active Comparator: Relaxation Training
    • Participants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day.

Clinical Trial Outcome Measures

Primary Measures

  • Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks
    • Time Frame: at baseline and in 2 weeks
    • The first fixated location and latency (msec) of each trial, the total dwell time (msec) in each interest area (IA) during the whole trial to assess the attentional bias in the experiment.

Secondary Measures

  • Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks
    • Time Frame: at baseline and in 2 weeks
    • Measured by Beck Depression Inventory (BDI-II). BDI-II is a self-report questionnaire that measures the severity of depression on a scale of 0 to 63. Higher total scores indicate more severe depressive symptoms.
  • Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks
    • Time Frame: at baseline and in 2 weeks
    • Measured by Hamilton Rating Scale for Depression (HAM-D). HAM-D is used by clinicians to rate the severity of depression and to evaluate recovery. HAM-D score ranges from 0 to 51, with higher scores indicating more severe depressive symptoms.
  • Mean Change from Baseline in State Mindfulness at 2 Weeks
    • Time Frame: at baseline and in 2 weeks
    • Measured by the Five Facet Mindfulness Questionnaire (FFMQ). FFMQ measures five mindfulness skills through these subscales: Non-Reactivity to Inner Experience, Observing/Noticing, Acting With Awareness, Describing, and Non-Judging of Experience. The five subscale scores can be combined to yield a total score ranging from 0 to 195, measuring global mindfulness skills, with higher scores indicating higher level of global mindfulness skills. For FFMQ subscales, scores range from 8 to 40, except for Non-Reactivity to Experience scores, which range from 7 to 35. Higher subscale scores indicate higher level of respective mindfulness skills.
  • Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks
    • Time Frame: at baseline and in 2 weeks
    • Measured by the Ruminative Responses Scale of the Response Styles Questionnaire (RRS). RRS measures the tendency to ruminate. RRS score ranges from 22 to 88, with higher scores indicate a stronger tendency to engage in ruminative thoughts.

Participating in This Clinical Trial

Inclusion Criteria

  • Meet Diagnostic and Statistical Manual (DSM-IV) diagnosis of depression – Consent to participate in the study and to be randomized to one of two groups Exclusion Criteria:

  • Current or past substance abuse, psychotic disorder,obsessive compulsive disorder , Post-Traumatic Stress Disorder, in the past 6 months – History of epilepsy or head trauma – Eye disorders – History of electroconvulsive therapy in the past 4 weeks.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Central South University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lingjiang Li, President of Chinese Psychiatry Society of Chinese Medical Association – Central South University
  • Overall Contact(s)
    • Li Lingjiang, MD Ph.D, +86 13807314575, LLJ2920@csu.edu.cn

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