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CompletedNCT04503343Updated Jul 21, 2022

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

An interventional study of non-drug intervention in Depressive Disorder, sponsored by Central South University. Completed at 1 site in China. Open to participants aged 16 Years to 34 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-07-21.

Sponsored by Central South University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
16 Years to 34 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Depressive Disorder

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03

In context

Depressive Disorder

4,847 studies on the registry are indexed under Depressive Disorder; 509 are open to participants now.

This study's enrollment of 120 is above the median of 80 across 3,997 interventional studies indexed under Depressive Disorder.

Browse Depressive Disorder studies →

Lead sponsor

Central South University is the lead sponsor of 131 studies on the registry; 29 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 34 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
120 participants (actual)

Study arms

  • 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

  • No intervention
    control group

    subjects are randomly divided into the control group and regularly followed up.

Interventions

  • Othernon-drug intervention

    mindfulness training, relaxation training, or electrical cerebellar stimulation

06

What researchers measure

Primary outcomes

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

    Cognitive function are measured by Faces Emotion Recognition Task

    Time frame: baseline

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

    Cognitive function are measured by Emotional Categorisation Task

    Time frame: baseline

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

    Cognitive function are measured by Emotional Recall Task

    Time frame: baseline

07

Study locations

1 site
  • The Second Xiangya Hospital of Central South University
    Changsha, Hunan 410011, China
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Jun 2022, 23 months.

Of 1,212 non-industry interventional studies with no phase under Depressive Disorder, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 43. This study's 23 months is close to that.

Counting every sponsor, half of 1,273 studies reached it within 23 months; a quarter within 13 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2020
First posted
Aug 7, 2020
StartActual
Jul 30, 2020
Primary completionActual
Jun 30, 2022
CompletionActual
Jun 30, 2022
Last update
Jul 21, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04503343
Responsible party
Jian-Jun Ou (Principal Investigator, Central South University) — Principal investigator
First posted
Aug 7, 2020
Start date
Jul 30, 2020
Primary completion
Jun 30, 2022
Completion
Jun 30, 2022
Last update
Jul 21, 2022

Study contacts

Jianjun Ou, doctor
study chair · Central South University
Runsen Chen, doctor
study director · Central South University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2022. You cannot join it, but the record below documents what was studied.

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