Protocol summary
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Study aim
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Determining the effectiveness of drug therapy by combining emotion regulation training and drug therapy on inhibition control, emotion regulation, cognitive flexibility and improvement of symptoms in patients with bipolar disorder I
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Design
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Clinical trial with a control group, with parallel groups, single-blind, randomized, phase 0 on 40 patients. For randomization, SCID-1 and SCID-1I will be selected as a purposeful sampling and will be randomly assigned on the website www.sealedenvebpe.com by the relevant administrator
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Settings and conduct
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Emotion regulation treatment for bipolar patients in Beheshti Hospital Zanjan is done in a group form. The study is single - blind and the patients will not be aware of the grouping .
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Participants/Inclusion and exclusion criteria
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Inclusion:
Being bipolar disorder I
Age between 18 and 50
Diploma
Willingness to participate in the research
Not drugs and alcohol in the last three months
Absence of cyclical bipolar disorder
Not suffering from severe psychiatric disorders
Not receiving psychological treatments at least one month before entering the research
The drug dose was stabilized two months
Non-entry:
Absence in treatment sessions
Starting to receive another similar psychological intervention
Lack of consent to continue treatment
Aggravation of the person's problems during the intervention and the need another intervention
Occurrence of suicidal thoughts during intervention sessions
Opting out of continuing the sessions
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Intervention groups
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20 patients bipolar disorder type 1
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Main outcome variables
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inhibitory control; emotion regulation; Cognitive flexibility; improvement of disease symptoms
General information
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Reason for update
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Correcting some items that were wrongly registered
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Acronym
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ERT
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IRCT registration information
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IRCT registration number:
IRCT20191229045931N2
Registration date:
2022-12-20, 1401/09/29
Registration timing:
prospective
Last update:
2024-04-14, 1403/01/26
Update count:
2
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Registration date
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2022-12-20, 1401/09/29
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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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2023-02-20, 1401/12/01
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Expected recruitment end date
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2023-08-23, 1402/06/01
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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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Comparing the effectiveness of drug therapy with the combination of emotion regulation training and drug therapy on inhibitory control, emotion regulation, cognitive flexibility and improvement of symptoms in patients with type I bipolar disorder.
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Public title
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Effect of emotion regulation training in bipolar disorder
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Having symptoms of bipolar disorder type I
Age range between 18 and 50 years
Education at least diploma
Interest of the participants to participate in the research based on the provisions of the written consent
Not using drugs and alcohol in the last three months
Absence of severe cyclical bipolar disorder
Not suffering from severe psychiatric disorders such as psychotic disorders, cognitive disorders and other psychiatric disorders
Not receiving psychological treatments at least one month before entering the research
Failure to receive psychological treatments at least one month before entering the study, a fixed drug dose two months before entering the study
Exclusion criteria:
Absence in treatment sessions
Starting to receive another similar psychological intervention at the same time as the current research
Lack of consent to continue treatment during the intervention process
Aggravation of the individual's problems during the intervention and the need to provide another intervention
Occurrence of suicidal thoughts during intervention sessions
Opting out of continuing the intervention sessions
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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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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Targeted sampling will be selected and assigned randomly on the website www.sealedenvebpe.com by the relevant administrator.
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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the patients were unware of the group allocations .
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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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2022-11-26, 1401/09/05
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Ethics committee reference number
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IR.ZUMS.REC.1401.252
Health conditions studied
1
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Description of health condition studied
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Bipolar disorder
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ICD-10 code
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F31
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ICD-10 code description
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A disorder characterized by two or more episodes in which the patient's mood and activity levels are significantly disturbed, this disturbance consisting on some occasions of an elevation of mood and increased energy and activity (hypomania or mania) and
Primary outcomes
1
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Description
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Inhibition control, depression and mania, emotion regulation, cognitive flexibility
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Timepoint
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Before treatment, after treatment, 3 months after treatment
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Method of measurement
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Go-No-Go task, Wisconsin Card Test, Young Mania Questionnaire, Hamilton Depression Questionnaire ،Gross emotion regulation questionnaire
Intervention groups
1
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Description
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Intervention group: Emotion regulation therapy, 8-session group, 20 people, Gross emotion regulation protocol, twice a week, 2-hour sessions.
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Category
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Treatment - Other
2
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Description
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Control group: This group does not receive treatment, this group will fill questionnaires and tasks in 3 stages before and after treatment and follow-up.
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Category
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Treatment - Other
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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Persons
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Not applicable
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available