An Eye Tracking Study of Affective Disorder Patients With Suicide Risk

This research tries to investigate the validity and reliability of eye-tracking technologies by using different paradigms (eg. free-view, pro-saccade and anti-saccade) which served as a novel way of evaluating suicide risk among affective disorder patients including bipolar and unipolar depression. All the participants including health control will be assessed by clinical interviewing, self-report assessment, cognitive evaluation and eye-tracking task.

Study Overview

• Status: Unknown
• Conditions: Bipolar Disorder; Suicide; Major Depressive Disorder
• Intervention / Treatment: Behavioral: eye-tracking

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

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: 12 years to 60 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Participants were recruited from outpatients in psychiatric clinic and clinical psychological clinic, and inpatients residing in the mental health hospital.

Most of the healthy volunteers were recruited from the advertisement posters in community and medical college.

There are two steps for screening. Firstly, each person was asked to complete the BDI (Beck Depression Inventory,21-items) to evaluate the depressive symptoms. Individuals with scores less than 13 and more than 20 were enrolled for this study.

Secondly, each individual has to be taken for a structural diagnostic interview (MINI-International Neuropsychiatric Interview, M.I.N.I.6.0.) in order to diagnosis current disorder and evaluate suicide risk by a psychiatrist who had already clinical consistency training.

Description

Inclusion Criteria:

• Diagnostic and Statistical Manual,DSM-IV diagnosis of depression or Bipolar disorder
• BDI-II>20(Suicide and disorder control group); BDI-II<13，no history of depression(Health control)
• Informed consent
• suicide attempt in the past 6 months(suicide risk group)

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?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Control Group	Behavioral: eye-tracking; After completing a demographics form, theBeck Depression Inventory,Beck Anxiety Inventory,Barratt Impulsiveness Scale and Ruminative Response Scale-21, each participant has to go to the eye-tracking room and seats in a height adjustable chair and places their chin in a chin rest which was positioned to make sure all participants' eye are in the same location relative to the camera and the monitor. There are 18 trials and 2 filler trials in the free-view task, each of which contains 4 pictures on the same screen for 25 seconds. There is also a gap screen between each trial lasting for 2 seconds when participants were asked to fixate in the center of the screen. During the experiment, participants are instructed to watch the screen as naturally as possible, and the initial location of the fixation of each trial and the total dwell time of each emotional images(negative, happy, neutral and suicide-related)and the changes of the pupil size were recorded.
Suicide Risk Group; patients with affective disorders(eg. bipolar disorder, major depression disorder) also have a history of suicide attempt in the past 6 months.	Behavioral: eye-tracking; After completing a demographics form, theBeck Depression Inventory,Beck Anxiety Inventory,Barratt Impulsiveness Scale and Ruminative Response Scale-21, each participant has to go to the eye-tracking room and seats in a height adjustable chair and places their chin in a chin rest which was positioned to make sure all participants' eye are in the same location relative to the camera and the monitor. There are 18 trials and 2 filler trials in the free-view task, each of which contains 4 pictures on the same screen for 25 seconds. There is also a gap screen between each trial lasting for 2 seconds when participants were asked to fixate in the center of the screen. During the experiment, participants are instructed to watch the screen as naturally as possible, and the initial location of the fixation of each trial and the total dwell time of each emotional images(negative, happy, neutral and suicide-related)and the changes of the pupil size were recorded.
Disorder Control Group; patients with affective disorders(eg. bipolar disorder, major depression disorder) and without suicide ideation or behavior.	Behavioral: eye-tracking; After completing a demographics form, theBeck Depression Inventory,Beck Anxiety Inventory,Barratt Impulsiveness Scale and Ruminative Response Scale-21, each participant has to go to the eye-tracking room and seats in a height adjustable chair and places their chin in a chin rest which was positioned to make sure all participants' eye are in the same location relative to the camera and the monitor. There are 18 trials and 2 filler trials in the free-view task, each of which contains 4 pictures on the same screen for 25 seconds. There is also a gap screen between each trial lasting for 2 seconds when participants were asked to fixate in the center of the screen. During the experiment, participants are instructed to watch the screen as naturally as possible, and the initial location of the fixation of each trial and the total dwell time of each emotional images(negative, happy, neutral and suicide-related)and the changes of the pupil size were recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eye movement performance during free-view task	The first fixated location and latency(msec)of eah trial, the total dwell time(msec) in each interest areas(IAs) during the whole trial to assess the attentional bias in the experiment.	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Scores in self-report assessment:Beck Depression Inventory	This scale is aimed to assess the clinical depressive symptom in the recent 7 days.	5 minutes
Scores in self-report assessment:Beck Anxiety Inventory	This scale is aimed to assess the clinical anxieous symptom in the recent 7 days	5 minutes
Scores in self-report assessment:Barratt Impulsiveness Scale	This scale is aimed to assess participant's impulsive trait.	5 minutes
Scores in self-report assessment:Ruminative Response Scale	This scale is aimed to assess participant's ruminative thinking process.	5 minutes

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: October 11, 2018
• First Submitted That Met QC Criteria: October 17, 2018
• First Posted (Actual): October 18, 2018

Study Record Updates

• Last Update Posted (Actual): October 18, 2018
• Last Update Submitted That Met QC Criteria: October 17, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: eye-tracking; eye movement; saccade
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Pathologic Processes; Bipolar and Related Disorders; Self-Injurious Behavior; Depressive Disorder; Disease; Bipolar Disorder; Suicide; Mood Disorders; Depressive Disorder, Major
• Other Study ID Numbers: Second Xiangya hospital CSU; Mental Health Insititute (Other Identifier: Second Xiangya Hospital)

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