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

Sponsor
Central South University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04071886
Collaborator
(none)
60
1
2
4
15

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Mindfulness-Based Training
  • Behavioral: Relaxation Training
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Effect of Short-Term Mindfulness-Based Training For Major Depression Disorder: An Eye-Tracking Study
Anticipated Study Start Date :
Sep 1, 2019
Anticipated Primary Completion Date :
Jan 1, 2020
Anticipated Study Completion Date :
Jan 1, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Mindfulness-Based Training

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
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.

Active Comparator: Relaxation Training

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

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

Outcome Measures

Primary Outcome Measures

  1. Mean Change from Baseline in Eye Movement Performance During Free-View Task at 2 Weeks [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 Outcome Measures

  1. Mean Change from Baseline in the Symptoms of Major Depression as Measured by BDI-II at 2 Weeks [at baseline and in 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.

  2. Mean Change from Baseline in the Symptoms of Major Depression as Measured by HAM-D at 2 Weeks [at baseline and in 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.

  3. Mean Change from Baseline in State Mindfulness at 2 Weeks [at baseline and in 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.

  4. Mean Change from Baseline in Tendency to Engage in Ruminative Responses at 2 Weeks [at baseline and in 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 40 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mental Health Institute & Faculty of Psychiatry of The Second Xiangya Hospital, Central South University Changsha Hunan China 410001

Sponsors and Collaborators

  • Central South University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lingjiang Li, President of Chinese Psychiatry Society of Chinese Medical Association, Central South University
ClinicalTrials.gov Identifier:
NCT04071886
Other Study ID Numbers:
  • Second Xiangya hospital EMEN
First Posted:
Aug 28, 2019
Last Update Posted:
Aug 28, 2019
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Lingjiang Li, President of Chinese Psychiatry Society of Chinese Medical Association, Central South University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Aug 28, 2019