Objectives: Bipolar Disorder (BD) is one of the most common psychological disorders. Considering to the role of executive function and emotion regulation in psychological disorders such as bipolar, this study aimed to assess the effectiveness of dialectical behavior therapy (main variable) on executive function and emotion regulation (dependent variables) among referred patients to Kargarnejad hospital in Kashan city. Main variable: Dialectical behavior therapy, Dependent variables: executive function and emotion regulation. Design: This clinical trial designed as pre-test, post-test and three month follow-up. Participants: The population of this clinical trial including all bipolar patients who had referred to the Kashan Kargarnejad hospital from April to Jaunary 2016 and were selected by available sampling method. The inclusion criteria were receiving Bipolar diagnosis in Yang Mania Rating Scale (YMRS) and Clinical Interview and the exclusion criteria included another psychotherapy, mania and psychotic episode and another psychiatry disorders during this project. Setting and conduct: 50 participants were divided randomly to experimental and control group, equally. The tools of this study were Yang Mania Rating Scale (YMRS), Difficulties of Emotion Regulation Scale (DERS), Beck Depression Inventory-II (BDI-II), Wisconsin Card Sorting Task (WCST) and Tower of Landon Task (TOL). Interventions: Dialectical behavior therapy in 12 group sessions, once a week.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017031233023N1
Registration date:2017-11-17, 1396/08/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-11-17, 1396/08/26
Registrant information
Name
Behrooz Afshari
Name of organization / entity
Kashan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 5558 1833
Email address
behrooz.afshari71@gmail.com
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2017-03-15, 1395/12/25
Expected recruitment end date
2017-09-16, 1396/06/25
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of dialectical behavior therapy on executive function and emotion regulation in bipolar spectrum disorders patients
Public title
The effectiveness of dialectical behavior therapy on executive function and emotion regulation
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Having an age of 18 til 45 years; Having a degree in secondary education or higher; Bipolar spectrum disorders based on DSM-5 diagnostic criteria.
exclusion criteria: Entrance to mania phase; Having a history of psychotic disorders; Receiving psychotherapy during past six months; Unwillingness to continue participating in the study; Failing to participate in more than two sessions of the study intervention; Had a history of substance abuse disorders.
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
From all participation's that meets inclusion criteria, 50 people randomly enter the study and then 25 participants for each group selected by Random assignment will be done, that by the use of computer-generated random numbers.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Kashan university of medical science
Street address
Ethics committee of kashan university of medical science, Qotb ravandi blv, Kashan
City
Kashan
Postal code
8713781147
Approval date
2017-02-08, 1395/11/20
Ethics committee reference number
IR.KAUMS.REC.1395.129
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
Emotion regulation
Timepoint
Before intervention, After intervention, three month after intervention
Method of measurement
Difficulties in emotion regulation scale
2
Description
executive function
Timepoint
Before intervention, After intervention, three month after intervention
Method of measurement
wisconsin card sorting task and tower of london task
3
Description
planning
Timepoint
Before intervention, After intervention, three month after intervention
Method of measurement
Tower of london task
4
Description
problem-solving
Timepoint
Before intervention, After intervention, three month after intervention
Method of measurement
wisconsin card sorting task
5
Description
cognitive flexibility
Timepoint
Before intervention, After intervention, three month after intervention
Method of measurement
wisconsin card sorting task
Secondary outcomes
1
Description
depression
Timepoint
befor of intervention, after of information, three month after intervention
Method of measurement
Beck depression inventory
Intervention groups
1
Description
Intervention group: This treatment is during the twelve 90-minute sessions for three months.
Category
Behavior
2
Description
Control group : control group include of medication depend on psychiatrist diagnosis .
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kargarnejad psychiatric hospital
Full name of responsible person
Ghoreishi PHD
Street address
kashan university of medical science, ghotbe ravandi blv, Kashan, Esfahan
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Research Deputy of kashan university of medical science
Full name of responsible person
Gholamali Hamidi
Street address
kashan university of medical science, ghotbe ravandi blv, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Deputy of kashan university of medical science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Kashan university of medical science
Full name of responsible person
Behrooz afshari golshekanani
Position
MSc student of clinical psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, Faculty of Medicine, Kashan university of medical science, ghotbe ravandi blv
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 9111
Fax
Email
behrooz.afshari71@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan university of medical science
Full name of responsible person
Behrooz afshari golshekanani
Position
MSc student of clinical psychology
Other areas of specialty/work
Street address
Kashan university of medical science, ghotbe ravandi blv, Kashan
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 9111
Fax
Email
behrooz.afshari71@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan university of medical science
Full name of responsible person
Behrooz afshari golshekanani
Position
MSc student of clinical psychology
Other areas of specialty/work
Street address
Kashan university of medical science, ghotbe ravandi blv, Kashan
City
Kashan
Postal code
8715988141
Phone
+98 31 5554 9111
Fax
Email
behrooz.afshari71@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)