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Completed

NCT Number: NCT04503343

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

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

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Key information

Age range

16 year–34 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-drug intervention

Other

mindfulness training, relaxation training, or electrical cerebellar stimulation

Primary outcomes

  1. The change of mindfulness training on cognitive function in healthy individuals

    Time frame: baseline

    Cognitive function are measured by Faces Emotion Recognition Task

  2. The change of mindfulness training on cognitive function in patients with first episode depression

    Time frame: baseline

    Cognitive function are measured by Emotional Categorisation Task

  3. The change of cerebellar electrical stimulation on cognitive function in healthy individuals

    Time frame: baseline

    Cognitive function are measured by Emotional Recall Task

Sponsors and collaborators

Lead sponsor

Central South University

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Aug 7, 2020
Registry last updated
Jul 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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