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Clinical Trials/NCT04071886
NCT04071886UnknownNot Applicable

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

Central South University1 site in 1 country60 target enrollmentStarted: September 1, 2019Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
60
Locations
1
Primary Endpoint
Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 40 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Arms & Interventions

Mindfulness-Based Training

Experimental

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

Intervention: Mindfulness-Based Training (Behavioral)

Relaxation Training

Active Comparator

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

Intervention: Relaxation Training (Behavioral)

Outcomes

Primary Outcomes

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 Outcomes

  • Mean Change from Baseline in State Mindfulness at 2 Weeks(at baseline and in 2 weeks)
  • Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks(at baseline and in 2 weeks)
  • Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks(at baseline and in 2 weeks)
  • Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks(at baseline and in 2 weeks)

Investigators

Sponsor
Central South University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lingjiang Li

President of Chinese Psychiatry Society of Chinese Medical Association

Central South University

Study Sites (1)

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