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

Study Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Other: non-drug intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Hunan
    • Changsha, Hunan, China, 410011
      • The Second Xiangya Hospital Of Central South University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 34 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Central South University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: July 24, 2020
• First Submitted That Met QC Criteria: August 4, 2020
• First Posted (Actual): August 7, 2020

Study Record Updates

• Last Update Posted (Actual): July 21, 2022
• Last Update Submitted That Met QC Criteria: July 20, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Mood Disorders; Depressive Disorder
• Other Study ID Numbers: MD201908

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No