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

Study Overview
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Brief Summary
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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.

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

Conditions
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MDD

Intervention / Treatment
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* Behavioral: Mindfulness-Based Training
* Behavioral: Relaxation Training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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eye-tracking, eye movement, mindfulness