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

NCT ID: NCT04503343

Last Updated: 2022-07-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-30
• Study Completion Date: 2022-06-30

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

Detailed Description

In this proposed study,the investigators will evaluate the effects of different non-pharmacological interventions (physical/psychological) on emotion-related cognitive function.This project will use a variety of intervention methods to conduct research in healthy individuals and patients with mood disorders. The main intervention methods include: (1) mindfulness training;(2) relaxation training;(3) cerebellar electrical stimulation.

The study will recruit 80 healthy subjects and 40 first-episode depression patients. The study consisted of three steps: First, subjects filled in personal data and completed the first screening, randomly assigned groups, and filled in the pre-intervention questionnaire;Second, give a one-time non-drug intervention (mindfulness training, relaxation training or cerebellar electrical stimulation);Step 3: After the intervention, the subjects filled in the post-intervention questionnaire and completed the cognitive task test.Clinical efficacy and safety assessment will be done at first time. The specific aims are to evaluate the effect of non-drug therapy on cognitive function in healthy individuals and patients with first episode depression. and the behavior was evaluated by cognitive function task.

Conditions

Depressive Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

intervention group

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).

Group Type: OTHER

non-drug intervention

Intervention Type: OTHER

mindfulness training, relaxation training, or electrical cerebellar stimulation

control group

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

non-drug intervention

mindfulness training, relaxation training, or electrical cerebellar stimulation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

-

Healthy individuals group:

1. Aged between 16 and 34;

2. 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:

1. Aged between 16 and 34;

2. Clinically diagnosed as having depression according to the DIAGNOSTIC and Statistical Manual of Mental Disorders (DSM-5);

3. First attack, not taking medicine, no risk of serious suicide NSSI.

Exclusion Criteria

1. There are serious physical diseases, such as epilepsy, brain trauma, intracranial space-occupying lesions, severe audiovisual disorders, congenital heart disease, etc.;

2. Both Hamilton Depression Scale and Beck Depression Self-Rating Scale indicate severe depression or severe mental illness;

3. Affected by mental illness, it is difficult to conduct smooth and effective verbal communication and psychological measurement operation.

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 34 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Central South University

OTHER

Sponsor Role: lead

Responsible Party

Jian-Jun Ou

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jianjun Ou, doctor

Role: STUDY_CHAIR

Central South University

Runsen Chen, doctor

Role: STUDY_DIRECTOR

Central South University

Locations

The Second Xiangya Hospital of Central South University

Changsha, Hunan, China

Countries

China

Other Identifiers

MD201908

Identifier Type: -

Identifier Source: org_study_id