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

Central South University

Status: Completed

Conditions: Depressive Disorder

Treatments: Other: non-drug intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04503343

MD201908

Details and patient eligibility

About

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

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 16 to 34 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

intervention group

Other group

Description:

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).

Treatment:

Other: non-drug intervention

control group

No Intervention group

Description:

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