Clinical trial NCT04503343: Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression
Official title: Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2020-08-07
Enrollment: 120
Sex: ALL
Minimum age (years): 16
Maximum age (years): 34
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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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.

Primary outcomes:
measure: The change of mindfulness training on cognitive function in healthy individuals
timeFrame: baseline
measure: The change of mindfulness training on cognitive function in patients with first episode depression
timeFrame: baseline
measure: The change of cerebellar electrical stimulation on cognitive function in healthy individuals
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Changsha
country: China
facility: The Second Xiangya Hospital of Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Jianjun Ou, doctor
role: STUDY_CHAIR
affiliation: Central South University
name: Runsen Chen, doctor
role: STUDY_DIRECTOR
References: