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Effectiveness of family psychoeducational on family caregiver Burden, Anexiety, Stress and Depression

Protocol summary

Summary
Objective: This randomized controlled trial evaluated the effectiveness of a group psycho-educational program on caregivers of mental disorders. Hundred family caregivers of patients with Schizophrenia and mood disorders that attending in Noor hospital, affiliated to Isfahan Behavioral Sciences Research Center, were the study population. In this study, Caregiver is one who is a member of the family (parents, children,..) and has the most frequent contact with the patients, helps to support the patient financially, has most frequently been collateral in the patients' treatment . The psycho-educational intervention that was used in this research consisted of four consecutive weekly sessions providing information about patients disorder process, teaching symptom management, teaching caregiver self care, discussing psychosocial issues, providing mutual support to one another, teaching them to monitor their own feelings, teaching coping skills and problem solving and it was offered in a group format. It was used because group education programs have been widely recommended as a valuable strategy to deliver support and information to family caregivers. The program followed up for a period of 3 months and caregiver burden was assessed by using the Zarit Burden Interview (ZBI).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138804272200N1
Registration date: 2009-09-09, 1388/06/18
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2009-09-09, 1388/06/18
Registrant information
Name
Saeid Pahlavanzadeh
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 1772 7861
Email address
pahlavanzadeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Behavioral Sciences Research Center of Isfahan University of Medical Sciences
Expected recruitment start date
2008-01-02, 1386/10/12
Expected recruitment end date
2008-07-17, 1387/04/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of family psychoeducational on family caregiver Burden, Anexiety, Stress and Depression
Public title
Family Caregivers of Mental Disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion Criteria: 1- Family member who is main caregiver at home. 2- aged at least 16 years. 3- being able to make a good communication. 4- being able to complete questionnaire. Exclusion Criteria: 1-Not participate in family education about mental disorders and caring of them. 2- Do not have any history of identified somatic and mental disorder and hospitalization.
Age
From 16 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Isfahan Behavioral Sciences Research Center
Street address
Noor Medical Center, Hasht Behesht, Ostandari Street
City
Isfahan
Postal code
Approval date
2008-04-15, 1387/01/27
Ethics committee reference number
24/11/4/12

Health conditions studied

1

Description of health condition studied
Schizophrenia Spectrom
ICD-10 code
F20,F21,F2
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders

2

Description of health condition studied
mood disorders
ICD-10 code
F30,F31,F3
ICD-10 code description
Mood [affective] disorders

Primary outcomes

1

Description
family caregiver burden
Timepoint
three months after the end of study
Method of measurement
questionnaire

2

Description
Anxiety
Timepoint
at the end of study & three months later
Method of measurement
questionnaire

3

Description
Depression
Timepoint
at the end of study & three months later
Method of measurement
questionnaire

4

Description
Stress
Timepoint
at the end of study & three months later
Method of measurement
questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention: The psycho-educational intervention that was used in this research consisted of four consecutive weekly sessions providing information about patients disorder process, teaching symptom management, teaching caregiver self care, discussing psychosocial issues, providing mutual support to one another, teaching them to monitor their own feelings, teaching coping skills and problem solving and it was offered in a group format.
Category
Behavior

2

Description
Control: routine care
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor Medical Center affiliated to Isfahan University of Medical Sciences
Full name of responsible person
Street address
Noor Medical Center , HASHT BEHESHT, Ostandari Street
City
Isfahan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Dr. Abbas Atari , Dean of Behavioral Sciences Research Center
Street address
Office of BSRC, Noor hospital
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Saeid Pahlavanzadeh
Position
MSc , Faculty member
Other areas of specialty/work
Street address
Mental Health Nursing Department, Nursing & Midwifery School, Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2960
Fax
Email
pahlavanzadeh@nm.mui.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Isfahan
Full name of responsible person
Ali Navidian
Position
Doctoral Student in Counseling & Faculty member
Other areas of specialty/work
Street address
Counseling Department,Education and Psychology Faculty
City
Isfahan
Postal code
Phone
+98 31 1650 2900
Fax
Email
alinavidian@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Mohsen Yazdani
Position
MSc and Faculty member
Other areas of specialty/work
Street address
Mental Health Nursing Department,Nursing & midwifery School,Isfahan University of Medical Sciences
City
Isfahan
Postal code
Phone
+98 31 1792 2960
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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