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

Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04503343
• Other study ID #: MD201908
• Status: Completed
• Phase: N/A
• Start date: July 30, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: July 2022
• Source: Central South University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 34 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depressive Disorder

Intervention

Other:
• non-drug intervention
mindfulness training, relaxation training, or electrical cerebellar stimulation

Locations

Country	Name	City	State
China	The Second Xiangya Hospital of Central South University	Changsha	Hunan

Sponsors (1)

Lead Sponsor	Collaborator
Central South University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The change of mindfulness training on cognitive function in healthy individuals	Cognitive function are measured by Faces Emotion Recognition Task	baseline
Primary	The change of mindfulness training on cognitive function in patients with first episode depression	Cognitive function are measured by Emotional Categorisation Task	baseline
Primary	The change of cerebellar electrical stimulation on cognitive function in healthy individuals	Cognitive function are measured by Emotional Recall Task	baseline