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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04503343
Enrollment
120
Registered
2020-08-07
Start date
2020-07-30
Completion date
2022-06-30
Last updated
2022-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive Disorder

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.

Interventions

OTHERnon-drug intervention

mindfulness training, relaxation training, or electrical cerebellar stimulation

Sponsors

Central South University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
16 Years to 34 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The change of mindfulness training on cognitive function in healthy individualsbaselineCognitive function are measured by Faces Emotion Recognition Task
The change of mindfulness training on cognitive function in patients with first episode depressionbaselineCognitive function are measured by Emotional Categorisation Task
The change of cerebellar electrical stimulation on cognitive function in healthy individualsbaselineCognitive function are measured by Emotional Recall Task

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026