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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Depressive Disorder

Intervention / Treatment
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* Other: non-drug intervention


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 34 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: intervention group<br>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<br>* mindfulness training, relaxation training, or electrical cerebellar stimulation<br>|
| No Intervention: control group<br>subjects are randomly divided into the control group and regularly followed up. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |