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

Primary Purpose

MDD

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Mindfulness-Based Training
Relaxation Training
Sponsored by
Central South University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for MDD focused on measuring eye-tracking, eye movement, mindfulness

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mindfulness-Based Training

Relaxation Training

Arm Description

Participants in the Mindfulness-Based Training arm will receive 2 weeks of Mindfulness-Based Training for at least 30 minutes every day.

Participants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
August 23, 2019
Last Updated
August 27, 2019
Sponsor
Central South University
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1. Study Identification

Unique Protocol Identification Number
NCT04071886
Brief Title
Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
Official Title
Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 1, 2019 (Anticipated)
Primary Completion Date
January 2020 (Anticipated)
Study Completion Date
January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
MDD
Keywords
eye-tracking, eye movement, mindfulness

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mindfulness-Based Training
Arm Type
Experimental
Arm Description
Participants in the Mindfulness-Based Training arm will receive 2 weeks of Mindfulness-Based Training for at least 30 minutes every day.
Arm Title
Relaxation Training
Arm Type
Active Comparator
Arm Description
Participants in the Relaxation Training arm will receive 2 weeks of Relaxation Training for at least 30 minutes every day.
Intervention Type
Behavioral
Intervention Name(s)
Mindfulness-Based Training
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Training
Intervention Description
Participants will listen to a 15-minute Relaxation Training tape twice a day.
Primary Outcome Measure Information:
Title
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks
Description
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.
Time Frame
at baseline and in 2 weeks
Secondary Outcome Measure Information:
Title
Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks
Description
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.
Time Frame
at baseline and in 2 weeks
Title
Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks
Description
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.
Time Frame
at baseline and in 2 weeks
Title
Mean Change from Baseline in State Mindfulness at 2 Weeks
Description
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.
Time Frame
at baseline and in 2 weeks
Title
Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks
Description
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.
Time Frame
at baseline and in 2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Lingjiang, MD Ph.D
Phone
+86 13807314575
Email
LLJ2920@csu.edu.cn
Facility Information:
Facility Name
Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410001
Country
China
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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