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

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 Overview

• Status: Unknown
• Conditions: MDD
• Intervention / Treatment: Behavioral: Mindfulness-Based Training; Behavioral: Relaxation Training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Li Lingjiang, MD Ph.D; Phone Number: +86 13807314575; Email: LLJ2920@csu.edu.cn

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410001
      • Recruiting
      • Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
Active Comparator: Relaxation Training; Participants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day.	Behavioral: Relaxation Training; Participants will listen to a 15-minute Relaxation Training tape twice a day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 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.	at baseline and in 2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 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.	at baseline and in 2 weeks
Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 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.	at baseline and in 2 weeks
Mean Change from Baseline in State Mindfulness at 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.	at baseline and in 2 weeks
Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 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.	at baseline and in 2 weeks

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2019
• Primary Completion (Anticipated): January 1, 2020
• Study Completion (Anticipated): January 1, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 27, 2019
• First Posted (Actual): August 28, 2019

Study Record Updates

• Last Update Posted (Actual): August 28, 2019
• Last Update Submitted That Met QC Criteria: August 27, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: mindfulness; eye-tracking; eye movement
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depressive Disorder; Depression; Depressive Disorder, Major
• Other Study ID Numbers: Second Xiangya hospital EMEN

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No