Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression
Primary Purpose
Depressive Disorder
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
non-drug intervention
Sponsored by
About this trial
This is an interventional treatment trial for Depressive Disorder
Eligibility Criteria
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.
Sites / Locations
- The Second Xiangya Hospital of Central South University
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
No Intervention
Arm Label
intervention group
control group
Arm 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).
subjects are randomly divided into the control group and regularly followed up.
Outcomes
Primary Outcome Measures
The change of mindfulness training on cognitive function in healthy individuals
Cognitive function are measured by Faces Emotion Recognition Task
The change of mindfulness training on cognitive function in patients with first episode depression
Cognitive function are measured by Emotional Categorisation Task
The change of cerebellar electrical stimulation on cognitive function in healthy individuals
Cognitive function are measured by Emotional Recall Task
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04503343
Brief Title
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
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
July 30, 2020 (Actual)
Primary Completion Date
June 30, 2022 (Actual)
Study Completion Date
June 30, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central South University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Other
Arm 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).
Arm Title
control group
Arm Type
No Intervention
Arm Description
subjects are randomly divided into the control group and regularly followed up.
Intervention Type
Other
Intervention Name(s)
non-drug intervention
Intervention Description
mindfulness training, relaxation training, or electrical cerebellar stimulation
Primary Outcome Measure Information:
Title
The change of mindfulness training on cognitive function in healthy individuals
Description
Cognitive function are measured by Faces Emotion Recognition Task
Time Frame
baseline
Title
The change of mindfulness training on cognitive function in patients with first episode depression
Description
Cognitive function are measured by Emotional Categorisation Task
Time Frame
baseline
Title
The change of cerebellar electrical stimulation on cognitive function in healthy individuals
Description
Cognitive function are measured by Emotional Recall Task
Time Frame
baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianjun Ou, doctor
Organizational Affiliation
Central South University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Runsen Chen, doctor
Organizational Affiliation
Central South University
Official's Role
Study Director
Facility Information:
Facility Name
The Second Xiangya Hospital of Central South University
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410011
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effects of Non-drug Therapy on Cognitive Function in Healthy Individuals and Patients With First Episode Depression
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