This is a 6 month randomized waiting-list and controlled clinical trial examines the adjuvant effect of psycho-education for treating and the relapse prevention of patients with bipolar disorder- type I. Diagnosis are made using DSM-IV-TR. Patients in the treatment group receive a structured psycho-education program in 9 sessions. The patients in the controlled group receive an unstructured program. The waiting-list group will not be psycho-educated during this trial. Assessments occur three times including pre-intervention, 3 months after the intervention, and 6 months after the intervention. The patients are evaluated using Young Mania Rating Scale, Hamilton Depression Rating Scale, and short-form of WHO-Quality of life inventory.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305213930N23
Registration date:2013-06-13, 1392/03/23
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-06-13, 1392/03/23
Registrant information
Name
Ahmad Ghanizadeh
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences, Shiraz University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1627 3070
Email address
ghanizad@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Shiraz University of Medical Sciences
Expected recruitment start date
2012-10-01, 1391/07/10
Expected recruitment end date
2014-11-20, 1393/08/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of group psycho-education on quality of life, relapse rate, and treatment compliance in patients with bipolar mood disorder- Type I
Public title
Efficacy of group psycho-education on patients with bipolar mood disorder- Type I
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosed Bipolar Disorder-type I in accordance with DSM-IV-TR, aged 18 to 50 years, and being euthymic at the time of enrollment. Exclusion criteria: patients with acute phase of mania, and active current substance use.
Age
From 18 years old to 50 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
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
Tehran University of Medical Sciecnes
Street address
Tehran University of Medical Sceinces
City
Tehran
Postal code
Approval date
2012-09-30, 1391/07/09
Ethics committee reference number
301/130/د/92
Health conditions studied
1
Description of health condition studied
Bipolar mood disorder
ICD-10 code
F30-ّ39
ICD-10 code description
Mood Disorder
Primary outcomes
1
Description
Hamilton Derepssion Rating Scale
Timepoint
baseline, 3 months, and 6 months
Method of measurement
Interveiwe
2
Description
Young Mania Rating Scale
Timepoint
baseline, 3 months, and 6 months
Method of measurement
Interveiwe
Secondary outcomes
empty
Intervention groups
1
Description
Waiting-list
Category
Other
2
Description
Placebo
Category
Treatment - Other
3
Description
Placebo
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research Center for Psychiatry and Behavioral Sciences, Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Street address
Hafez Hospital
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical sciences
Full name of responsible person
Gholam Reza Hatam
Street address
Hafez Hospital
City
Shiraz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical sciences
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
Iran University of Medical Sciences
Full name of responsible person
Behrooz Birashk
Position
Psychologist, PhD
Other areas of specialty/work
Street address
Institute of Psychiatry, Sattarkhan Street
City
Tehran
Postal code
Phone
+98 21 6655 1515
Fax
Email
behrooz.birashk@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ahmad Ghanizadeh
Position
MD
Other areas of specialty/work
Street address
hafez Hospital, Department of Psychiatry
City
Shiraz
Postal code
Phone
+98 71 1627 3070
Fax
Email
ghanizad@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Sharing plan
Deidentified Individual Participant Data Set (IPD)