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

NCT04071886 | Unknown

• 1 other identifier: Second Xiangya hospital EMEN
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

MDD

Keywords

eye-tracking; eye movement; mindfulness

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

Study Arms (2)

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.

Behavioral: Mindfulness-Based Training

Relaxation Training

ACTIVE COMPARATOR

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

Behavioral: Relaxation Training

Interventions

Mindfulness-Based Training BEHAVIORAL

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.

Mindfulness-Based Training

Relaxation Training BEHAVIORAL

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

Relaxation Training

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

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

Changsha, Hunan, 410001, China

RECRUITING

MeSH Terms

Interventions

Relaxation Therapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Central Study Contacts

Li Lingjiang, MD Ph.D

CONTACT

+86 13807314575; LLJ2920@csu.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: President of Chinese Psychiatry Society of Chinese Medical Association

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: January 1, 2020
• Study Completion: January 1, 2020
• Last Updated: August 28, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)