The Purpose of Study: Efficacy of cognitive behavioral group therapy on depression, anxiety and self-esteem of patients with bipolar disorder type I؛Inclusion criteria: Diagnosing bipolar disorder type 1 according to DSM-IV-TR؛ Age of 20 to 60.Satisfaction for including treatment؛Exclusion criteria: Study Society were selected among patients with bipolar I disorder, admitted in Ibn-e-Sina hospital because of acute phase and stabilized with medications In 1391.30 participants were selected based on convenient sampling and randomly allocated in two equal-size groups of intervention vs. control. Intervention group were under 10 sessions of a protocol based cognitive behavioral group therapy, while participants in control group were under 10 sessions of an unstructured supportive group with neither skill nor cognitive behavioral training.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015080518937N2
Registration date:2016-06-21, 1395/04/01
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-21, 1395/04/01
Registrant information
Name
hamid seifi
Name of organization / entity
Islamic Azad University Torbatejam
Country
Iran (Islamic Republic of)
Phone
+98 51 3365 5347
Email address
vjafarnia@yahoo.com
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2012-03-20, 1391/01/01
Expected recruitment end date
2012-09-09, 1391/06/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of cognitive behavioral group therapy on depression, anxiety and self-esteem of patients with bipolar disorder type I
Public title
Cognitive behavioral group therapy on depression, anxiety and self-esteem
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:Diagnosing bipolar disorder type 1 according to DSM-IV-TR؛ improving from critical phase according to clinical interview and Beck depression exam and Mania exam of Yung؛ Age of 20 to 60.Satisfaction for including treatment؛
Exclusion criteria:Accompanying with missus of drug؛Other Serious Psychological illnesses؛ Mental Retardation؛ Other Psychological Treatment during the intervention.
Age
From 20 years old to 60 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Azad university torbat-e- jam
Street address
Km 5 of torbat-e- jam road
City
torbat-e- jam
Postal code
Approval date
2011-09-23, 1390/07/01
Ethics committee reference number
11820701901013
Health conditions studied
1
Description of health condition studied
Bipolar
ICD-10 code
F31.0
ICD-10 code description
Bipolar affective disorder, current episode hypomanic
Primary outcomes
1
Description
Depression
Timepoint
One week before intervention-the end point of intervention-one month after the end of intervention; Two and six months after intervention
Method of measurement
Beck exam
2
Description
Anxiety
Timepoint
One week before intervention-the end point of intervention-one month after the end of intervention; Two and six months after intervention
Method of measurement
Beck exam
Secondary outcomes
1
Description
Self-Confidence
Timepoint
One week before intervention-the end point of intervention-one month after the end of intervention; Two and six months after intervention
Method of measurement
Izang Exam
Intervention groups
1
Description
The experimental group received cognitive and behavioral education during 9 sessions 90 minutes.
Category
Behavior
2
Description
The control group received life skills education during 8 sessions.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ibn-e-Sina Hospital
Full name of responsible person
Hamid Seifi
Street address
City
Mashhad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Azad University of Torbat-e-jam
Full name of responsible person
MohammadHosein Bayyazi
Street address
Km 5 of torbat-e- jam road
City
Torbat-e-jam
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Azad University of Torbat-e-jam
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
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Seifi
Position
Expert
Other areas of specialty/work
Street address
Number16, Hashemieh10
City
Mashhad
Postal code
Phone
+98 51 3365 5347
Fax
Email
h.seifi63@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hamid Seifi
Position
M.D
Other areas of specialty/work
Street address
Number16, Hashemieh10
City
Mashhad
Postal code
Phone
+98 51 3365 5347
Fax
Email
h.seifi63@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Scienses
Full name of responsible person
Hamid Seifi
Position
P.hd
Other areas of specialty/work
Street address
Ibn-e-Sina Hospital Bu Ali Square
City
Mashhad
Postal code
Phone
+98 51 3711 2540
Fax
Email
h.seifi63@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)