the influence of family group psycho-education on relapse rate and length of stay in hospital in hospitalized Patients with bipolar mood disorder type Ι
The purpose of the study is to assess the effectiveness of family group Psychoeducation on the reduction of recurrence in patients with bipolar disorder. In this study, patients with bipolar , randomly divided into two groups. Both groups of patients in Qazvin hospitals are selected.
A sample of 64 participants, which will be divided equally into two groups. Of all patients Inventory Beck and Young Mania (depending on the phase of disease) and the Family Questionnaire will be taken. The experimental group received group family psychoeducation .Psychoeducation is done to the family intervention group. Number of sessions: 4 sessions on a weekly basis. Each session will be held for 60 minutes. Themed sessions such as training in line with the nature of bipolar disorder; early signs of relapse; treatment of diseases; implementation strategies at the time of relapse; Introduction to reassertion of continued support systems ; treatment will be provided; anger management education; problem solving. Medical treatment will not be affected durinf the study .After at least 6 months and a maximum of 9 months follow-up , will be compared the two groups in terms of recurrence, number of hospitalization, severity of symptoms, length of stay in hospital , family adaptation . family group psycho-education on these issues will be evaluated.The inclusion criteria were: diagnosis of bipolar disorder based on structured psychiatric interview ; the patient's life in a family environment and having at least one family member to attend training sessions ; aged 18 to 65 years ; informed consent.
Exclusion criteria: lack of consent from the patient or the patient's family to participate in research project ; psychological training for families or patients in the control group, in the course of the study ; the absence of key members of the family in even one session of training.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016091612018N5
Registration date:2016-10-10, 1395/07/19
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-10-10, 1395/07/19
Registrant information
Name
Hossein Javdani
Name of organization / entity
Tabriz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1441 2002
Email address
javdanih@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Governmental
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-07-05, 1395/04/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the influence of family group psycho-education on relapse rate and length of stay in hospital in hospitalized Patients with bipolar mood disorder type Ι
Public title
Effectiveness of family group Psychoeducation on the reduction of recurrence in patients with bipolar disorder
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria were: diagnosis of bipolar disorder based on structured psychiatric interview (SCID), according to diagnostic criteria revised fourth edition of Diagnostic and Statistical Manual of Mental Disorders ; the patient's life in a family environment and having at least one family member to attend training sessions ; aged 18 to 65 years ; informed consent.
Exclusion criteria: lack of consent from the patient or the patient's family to participate in research project ; psychological training for families or patients in the control group, in the course of the study ; the absence of key members of the family in even one session of training.
Age
From 18 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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
Ethics Committee of Qazvin University Medical Science
Street address
Qazvin University of Medical Sciences , Shahid Bahonar Blvd
City
Qazvin
Postal code
Approval date
2015-09-30, 1394/07/08
Ethics committee reference number
IR.QUMS.REC.1394.136
Health conditions studied
1
Description of health condition studied
Bipolar affective disorder
ICD-10 code
F 31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
Recurrency
Timepoint
9 months after the intervention .
Method of measurement
the number of hospitalization during follow up .
2
Description
the number of hospitalization days .
Timepoint
9 months after intervention .
Method of measurement
Review of hospital records during follow up .
3
Description
Depression
Timepoint
Baseline and 9 month after intervention .
Method of measurement
Beck depression inventory
4
Description
mania
Timepoint
Baseline and 9 months after the intervention .
Method of measurement
Young Mania Scale
Secondary outcomes
1
Description
Family adaptation
Timepoint
Baseline and 9 months after the intervention.
Method of measurement
Mac Master questionnaire
Intervention groups
1
Description
Control group: no intervention
Category
N/A
2
Description
Intervention group:Psychoeducation to family patients . Number of sessions: 4 ; weekly basis ; time each session 60 minutes.
Category
Early detection
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman Hospital
Full name of responsible person
Dr Marzieh Javani
Street address
22 Bahman Hospital , Rah-ahan avenue , Street Parastar
City
Qazvin
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Qazvin University of Medical Sciences
Full name of responsible person
Taghi Naserpoor
Street address
Qazvin University of Medical Sciences , Shahid Bahonar Blvd
City
Qazvin
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research, Qazvin 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
Qazvin University of Medical Science
Full name of responsible person
Dr Marzieh Javani
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
22 Bahman Hospital , Rah-ahan avenue , Street Parastar
City
Qazvin
Postal code
Phone
+98 28 3355 5054
Fax
Email
marziehjavani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr Marzieh javani
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
22 Bahman Hospital , Rah-ahan avenue , Street Parastar
City
Qazvin
Postal code
Phone
+98 28 3355 5054
Fax
Email
marziehjavani@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Science
Full name of responsible person
Dr Marzieh javani
Position
Resident of Psychiatry
Other areas of specialty/work
Street address
22 Bahman Hospital , Rah-ahan avenue , Street Parastar
City
Qazvin
Postal code
Phone
+98 28 3355 5054
Fax
Email
marziehjavani@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)