Protocol summary
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Study aim
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Comparison of the Effectiveness of Combined Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy on Depression, Emotion Regulation, Response Inhibition, Problem Solving in Patients with Bipolar Disorders
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Design
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The present study is a clinical trial with pre-test, post-test and parallel group that will be randomized.
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Settings and conduct
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Samples are cited by a psychiatrist as per the admission criteria and, if not included in the exclusion criteria, enter the experimental groups. Then, after obtaining informed consent to participate in the research, the Hamilton Depression Rating Scale, the Gross Emotion Regulation Questionnaire, the GO no GO test and Tower of London are presented. The tDCS treatment program is then administered to the experimental group for 10 sessions of 20 minutes.
The droge group will receive psychiatric drugs. It should be noted that the samples will not be admitted to the outpatient ward and referred to an outpatient psychiatrist's office, as well as the medications received by the psychiatrist from a medication category and in fact no significant differences in the medications as far as possible. Groups should be homogenous in this regard. After the intervention, the questionnaires and re-evaluation tests, as well as three months after the intervention, will be conducted to follow up the results. In order to prevent bias, the patient will be evaluated by someone other than the therapist.
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Participants/Inclusion and exclusion criteria
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Type 1 bipolar disorder with psychiatrist diagnosis
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Intervention groups
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Combination Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy Group.
and Pharmacotherapy Group
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Main outcome variables
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Depression, Emotion Regulation, Response Inhibition, Problem Solving
General information
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Reason for update
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The present study was performed in a double-blind type and the researcher considered it necessary to update it.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191229045931N1
Registration date:
2020-08-24, 1399/06/03
Registration timing:
retrospective
Last update:
2022-07-11, 1401/04/20
Update count:
2
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Registration date
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2020-08-24, 1399/06/03
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-21, 1398/11/01
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Expected recruitment end date
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2020-08-20, 1399/05/30
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Comparison of the Effectiveness of Combined Transcranial Direct Current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy on Depression, Emotion Regulation, Response Inhibition, Problem Solving in Patients with Bipolar Disorders
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Public title
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Effectiveness of Combined Transcranial Direct current Stimulation (tDCS) with Pharmacotherapy and Pharmacotherapy in Bipolar Disorders
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Type 1 bipolar disorder at the discretion of a psychiatrist
Willingness to participate in research
Age range minimum 18 and maximum 50 years
At least third grade education
No severe psychiatric disorders such as psychotic disorders and cognitive impairment
Lack of history of epileptic seizures and history of head injury
Failure to receive psychological and technological therapies at least one month before entering the study
Exclusion criteria:
Severe psychiatric disorders such as psychotic disorders and cognitive impairment
History of epileptic seizures and history of head injury
Consumption of drugs and alcohol
Existence of suicidal thoughts
Existence of rapid cycles of mania
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Age
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From 18 years old to 50 years old
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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- Investigator
- Outcome assessor
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Sample size
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Target sample size:
30
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Random Number Generator v1.3 program will be used to assign sample members to two experimental groups. In this way, the number of sample people is given to this software and this program randomly places each number in a group according to its function.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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In this study, the evaluator and the therapist are separated and blinded, so that the therapist does not know how to evaluate and they are separated from each other.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-02-05, 1398/11/16
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Ethics committee reference number
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IR.ZUMS.REC.1398.452
Health conditions studied
1
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Description of health condition studied
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It is a bipolar disorder
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ICD-10 code
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F31.4
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ICD-10 code description
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Bipolar disorder, current episode depressed, severe, without psychotic features
Primary outcomes
1
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Description
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Depression
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Timepoint
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10 day and 3 month
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Method of measurement
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Hamilton Depression Scale
2
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Description
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Emotion Regulation
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Timepoint
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10 day and 3 month
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Method of measurement
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Grass emotion regulation questionnaire
3
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Description
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Response Inhibition
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Timepoint
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10 day and 3 month
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Method of measurement
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GO no GO test
4
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Description
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Problem Solving
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Timepoint
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10 day and 3 month
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Method of measurement
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the tower of London
Secondary outcomes
1
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Description
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impulsivity
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Timepoint
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10 day and 3 month
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Method of measurement
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The Bart impulsivity scale
Intervention groups
1
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Description
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Intervention Group: Combination of tDCS and medication:The tDCS treatment program was performed for 10 sessions of 20 minutes (F3) and (F4) for the experimental group. The electric current by these electrodes, after passing through different areas (scalp, skull, etc.), reaches the surface of the cerebral cortex.The current that reaches this area charges the neurons It is electrified and causes positive and negative poles, which leads to a change in the activity of that area.
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Category
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Treatment - Devices
2
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Description
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Intervention group: Medication: Mood stabilizing drugs will be prescribed by a psychiatrist.
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Category
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Treatment - Drugs
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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No
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Title of funding source
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No funding
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Proportion provided by this source
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1
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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No - There is not a plan to make this available
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Justification/reason for indecision/not sharing IPD
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"No more information
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Study Protocol
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No - There is not a plan to make this available
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Statistical Analysis Plan
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No - There is not a plan to make this available
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Informed Consent Form
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No - There is not a plan to make this available
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Clinical Study Report
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No - There is not a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available