The effect of family Psycho-education of bipolar patients on family expressed emotion and relapse
Design
Study is done as clinical trial on the family with patients who diagnosed to bipolar disorder and hospitalized in 22 Bahman hospital of Qazvin, in the recent 6 months.
Settings and conduct
The aim of this study is evaluating the effect of psychological education of families of patients with bipolar disorder on families' emotional expression and disease relapse. Study is done as clinical trial on family with patients and hospitalized in 22 Bahman hospital of Qazvin, in the recent 6 months. Inclusion criteria are an age range from 20 to 60 years old and patients in the same condition of disease. In the case of dissatisfaction, Family is excluded of the study. Families are attended to a general session to justify the outline of method and to fill questionnaire. They are educated weekly through an educational set for two sessions in 2 hours. The educational sessions are present by psychologist researcher in a conference room at the hospital. After 6 months, families are invited to fill the questionnaire, and disease relapse is assessed by psychologist researcher by interview.
Participants/Inclusion and exclusion criteria
Inclusion criteria: A member of family with bipolar disorder diagnosed by psychologist, trusty patients' caregiver, family or caregiver without disease symptoms history, family with hospitalized patients in a recent 6 months in center, patients in the same condition of disease severity and in age range from 20 to 60 years old.
Exclusion criteria: contributed caregivers with psychiatric disease, and family with dissatisfaction
Intervention groups
Intervention group: Family of patients with bipolar disorder
Type of intervention: Weekly training using an educational set in two sessions for 2 hours
Main outcome variables
Expressed emotion; The rate of disease relapses
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180223038835N2
Registration date:2018-04-07, 1397/01/18
Registration timing:retrospective
Last update:2018-04-07, 1397/01/18
Update count:0
Registration date
2018-04-07, 1397/01/18
Registrant information
Name
Zahra Hashemi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3355 5978
Email address
z.hashemi@qums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-27, 1396/07/05
Expected recruitment end date
2018-03-25, 1397/01/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of family Psycho-education of bipolar patients on family expressed emotion and relapse
Public title
The effect of family Psycho-education of bipolar patients and relapse
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
A member of family with bipolar disorder diagnosed by psychologist
Trusty patients' caregiver
Family or caregiver without disease symptoms history
Family with hospitalized patients in a recent 6 months in center
Patients in the same condition of disease severity
Age range from 20 to 60 years old
Exclusion criteria:
Contributed caregivers with psychiatric disease
Family with dissatisfaction
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Qazvin University of Medical Sciences
Street address
Shahid Bahonar Blvd.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Approval date
2017-09-24, 1396/07/02
Ethics committee reference number
IR.QUMS.REC1396.273
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31
ICD-10 code description
Bipolar disorder
Primary outcomes
1
Description
Expressed emotion
Timepoint
Before and 6 months after intervention
Method of measurement
Family Questionnaire (FQ)
Secondary outcomes
1
Description
The Rate of disease relapses
Timepoint
Before and 6 months after intervention
Method of measurement
Interview
Intervention groups
1
Description
Intervention group: Family of patients with bipolar disorder
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
22 Bahman hospital of Qazvin
Full name of responsible person
Dr Seyede Zahra hashemi
Street address
22 Bahman Hospital, Rah'ahan street, Qazvin.
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Amir Peymani
Street address
Vice chancellor for research, Qazvin University of Medical Sciences, Valiasr street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qazvin 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
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyede Zahra Hashemi
Position
Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Rah'ahan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyed Mohsen Zamir
Position
Associate
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Rah'ahan street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Dr Seyede Zahra Hashemi
Position
Specialist
Latest degree
Ph.D.
Other areas of specialty/work
Psychiatrics
Street address
22 Bahman Hospital, Rah'ahan Street, Qazvin
City
Qazvin
Province
Qazvin
Postal code
34139-96134
Phone
+98 28 3333 5800
Email
dr.zahra.hashemi.78@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