Effectiveness of dialectical behavioral therapy on executive function, affective control and severity of symptoms in patients with bipolar disorder type I.
Determine the effectiveness of dialectical behavioral therapy on executive function, emotional control and severity of symptoms in patients with bipolar disorder type I.
Design
This study is a randomized controlled clinical trial with 50 patients randomly divided into two groups of 25.
Settings and conduct
After obtaining informed consent, patients who are referred to Khorshid Hospital and are diagnosed to be affected by bipolar disorder by psychiatrist and are eligible to enter the study will be included. Before the start of treatment, all patients will be screened, and then the intervention group will participate in psychotherapy sessions. After treatment, all the patients will be subjected to do a post-test to compare their results.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Being in the maintenance phase of bipolar I; being at the age of 20 to 45 years; education level of at least grade 3 of guidance school. exclusion criteria: personality disorders, using alcohol and drugs , organic problems in patients, receiving other psychiatric interventions during previous 6 months , using simultaneous psychotherapy and having psychotic symptoms.
Intervention groups
The intervention group will receive dialectical behavioral therapy during 12 sessions (once a week), which will be held by psychiatrists and psychologists, and the control group won't receive any intervention.
Main outcome variables
The severity of the symptoms of depression and mania, Executive function score, Affective control score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180909040974N1
Registration date:2018-12-19, 1397/09/28
Registration timing:registered_while_recruiting
Last update:2018-12-19, 1397/09/28
Update count:0
Registration date
2018-12-19, 1397/09/28
Registrant information
Name
Fatemeh Zargar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3222 2475
Email address
f.zargar@med.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-10-06, 1397/07/14
Expected recruitment end date
2019-01-04, 1397/10/14
Actual recruitment start date
2018-10-06, 1397/07/14
Actual recruitment end date
2019-03-05, 1397/12/14
Trial completion date
2019-05-04, 1398/02/14
Scientific title
Effectiveness of dialectical behavioral therapy on executive function, affective control and severity of symptoms in patients with bipolar disorder type I.
Public title
Effectiveness of dialectical behavioral therapy in the treatment of patients with bipolar disorder type I.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
All patients with bipolar type I, which are in the phase of maintenance
Being at the age of 20 to 45 years old
Minimum 8 classes education
Exclusion criteria:
Having a simultaneous personality disorder
Drinking alcohol and drug use
Physical problems such as seizure in patients
Receive any other psychotherapy, simultaneously or during last 6 months
The presence of psychotic symptoms
Presence a concurrent course of mania in patients
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Actual sample size reached:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Eligible subjects are randomly assigned to either intervention or control group through stratified block randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Khorshid Hospital, Hashtbehesht Ave, Corner of the Ostandari's Street
City
Isfahan
Province
Isfehan
Postal code
8199888945
Approval date
2018-05-08, 1397/02/18
Ethics committee reference number
IR.MUI.MED.REC.1397.045
Health conditions studied
1
Description of health condition studied
bipolar disorder type I
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
depression score
Timepoint
At the beginning of study(before the intervention begins) and after the intervention(3 months later)
Method of measurement
Beck Depression Inventory
2
Description
Executive function score
Timepoint
At the beginning of study(before the intervention begins) and after the intervention(3 months later)
Method of measurement
Color Trails Test
3
Description
Affective control score
Timepoint
At the beginning of study(before the intervention begins) and after the intervention(3 months later)
Method of measurement
Affective Control Scale
4
Description
The severity of Young mania
Timepoint
At the beginning of study(before the intervention begins) and after the intervention(3 months later)
Method of measurement
Young Mania Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The intervention group will receive dialectical behavioral therapy during 12 sessions(once a week), which will be held by psychiatrists and psychologists.
Category
Behavior
2
Description
Control group: The control group won't receive any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Khorshid hospital
Full name of responsible person
Naimeh Haghshenas
Street address
No. 8, intersection of Hashtbehesht Street, Ostandari Avenue
City
Esfahan
Province
Isfehan
Postal code
8199888945
Phone
+98 31 3222 2127
Email
naimeh.a.h@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Doctor Mansour Siavash
Street address
No. 8, intersection of Hashtbehesht Street, Ostandari Avenue
City
Isfahan
Province
Isfehan
Postal code
8199888945
Phone
+98 31 3222 2127
Email
naimeh.a.h@gmail.com
Web page address
https://mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Naimeh Haghshenas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 8, intersection of Hashtbehesht Street, Ostandari Avenue
City
Isfahan
Province
Isfehan
Postal code
8199888945
Phone
+98 31 3222 2127
Email
naimeh.a.h@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Naimeh Haghshenas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 8, intersection of Hashtbehesht Street, Ostandari Avenue
City
Isfahan
Province
Isfehan
Postal code
8199888945
Phone
+98 31 3222 2127
Email
naimeh.a.h@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Naimeh Haghshenas
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Psychiatrics
Street address
No. 8, intersection of Hashtbehesht Street, Ostandari Avenue
City
Isfahan
Province
Isfehan
Postal code
8199888945
Phone
+98 31 3222 2127
Email
naimeh.a.h@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD