Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression

NCT04503343 | Completed

• 1 other identifier: MD201908
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Mindfulness training, relaxation training, and cerebellar electrical stimulation were used to intervene in the cognitive function of healthy individuals and individuals with first episode depression

Conditions

Depressive Disorder

Outcome Measures

Primary Outcomes (3)

• The change of mindfulness training on cognitive function in healthy individuals

  Cognitive function are measured by Faces Emotion Recognition Task

  baseline

• The change of mindfulness training on cognitive function in patients with first episode depression

  Cognitive function are measured by Emotional Categorisation Task

  baseline

• The change of cerebellar electrical stimulation on cognitive function in healthy individuals

  Cognitive function are measured by Emotional Recall Task

  baseline

Study Arms (2)

intervention group

OTHER

subjects are randomly divided into the intervention group. and they will be given a one-time non-drug intervention(mindfulness training, relaxation training or electrical cerebellar stimulation).

Other: non-drug intervention

control group

NO INTERVENTION

subjects are randomly divided into the control group and regularly followed up.

Interventions

non-drug intervention OTHER

mindfulness training, relaxation training, or electrical cerebellar stimulation

intervention group

Eligibility Criteria

• Age: 16 Years - 34 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy individuals group:
• Aged between 16 and 34;
• Does not meet the criteria of the DIAGNOSTIC and Statistical Manual of Mental Disorders, DSM-5,Does not meet the diagnosis of depression, bipolar disorder and other mental disorders.
• First episode depression group:
• Aged between 16 and 34;
• Clinically diagnosed as having depression according to the DIAGNOSTIC and Statistical Manual of Mental Disorders (DSM-5);
• First attack, not taking medicine, no risk of serious suicide NSSI.

You may not qualify if:

• There are serious physical diseases, such as epilepsy, brain trauma, intracranial space-occupying lesions, severe audiovisual disorders, congenital heart disease, etc.;
• Both Hamilton Depression Scale and Beck Depression Self-Rating Scale indicate severe depression or severe mental illness;
• Affected by mental illness, it is difficult to conduct smooth and effective verbal communication and psychological measurement operation.

Sponsors & Collaborators

• Central South University: lead

Study Sites (1)

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

Location

MeSH Terms

Conditions

Depressive Disorder

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Jianjun Ou, doctor

  Central South University

  STUDY CHAIR

• Runsen Chen, doctor

  Central South University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 24, 2020
• First Posted: August 7, 2020
• Study Start: July 30, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: July 21, 2022

Record last verified: 2022-07

Locations

CN (1)