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

MDD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04071886
• Other study ID #: Second Xiangya hospital EMEN
• Status: Recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: January 2020

Study information

• Verified date: August 2019
• Source: Central South University
• Contact: Li Lingjiang, MD Ph.D
• Phone: +86 13807314575
• Email: LLJ2920[@]csu.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depressive Disorder, Major
• MDD

Intervention

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.
• Relaxation Training
Participants will listen to a 15-minute Relaxation Training tape twice a day.

Locations

Country	Name	City	State
China	Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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