The aim the present study is to examine the efficacy of Psychosocial intervention for family burden in families with schizophrenic patients. The participants, who recruited via systematic random sampling, are consisting of 40 family members of schizophrenic patients referred to psychiatric clinics in Shiraz. Participants then divided to intervention and control groups randomly. Inclusion criteria are: 1- definite diagnosis of schizophrenia or schizo-affective disorder in patient; 2- a family member who lives with or be in-charge of the patient; 3- desire of family member for participating in study. Exclusion criteria are: 1- the diagnosis of learning disability in the family member; 2- diagnosis of personality disorders that could interfere intrusively with participation in intervention sessions. Psychosocial intervention consists of many interventions such as giving insight to family members about the nature and manifestations of schizophrenia, problem solving skills, life skills and communication inside the family. The participants in the intervention group will participate in 6 intervention sessions. In this study, independent variable is Psychosocial intervention which done by only one therapist and dependent variable is family burden in the two groups that will be measured before the intervention, immediately after, one month, six months and one year after finishing intervention.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201203129267N1
Registration date:2014-05-16, 1393/02/26
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-05-16, 1393/02/26
Registrant information
Name
Giti Setoodeh
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4254
Email address
setoodeh@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Shiraz University of Medical Sciences
Expected recruitment start date
2013-03-09, 1391/12/19
Expected recruitment end date
2014-03-10, 1392/12/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of psycho- social intervention for psychological burden in families of schizophrenic patients
Public title
Efficacy of psychosocial intervention for psychological burden in families of schizophrenic patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: 1- definite diagnosis of schizophrenia or schizo-affective disorders through a psychiatrist; 2- a family member who lives with patient and/or be responsible for caring the patient; 3- a family member who would like to attain and participate in psychosocial intervention and assign the consent form.
Exclusion criteria: 1- learning disability diagnosed through a psychiatrist; 2- personality disorders diagnosed through a psychiatrist that could interfere with psychosocial intervention.
Age
From 18 years old to 35 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The participants are recruited via systematic randomization sampling.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Commitee in Shiraz University of Medical Sciences
Street address
Ethics Commitee, Shiraz University of Medical Sciences, Zand Street, Beside Helal Ahmar, Shiraz, Iran
City
Shiraz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
91-01-08-4268
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20,F23,F2
ICD-10 code description
Schizophrenia, schizotypal and delusional disorders
Primary outcomes
1
Description
family burden
Timepoint
immedietly, 1month, 6 months, 1 year after finishing the intervention.
Method of measurement
Family Burden Questionnaire
Secondary outcomes
1
Description
recurrence of the disorder
Timepoint
immediately, 1 month, 6 months, 1 year after finishing the intervention.
Method of measurement
examining the times of hospitalization
Intervention groups
1
Description
Intervention group will be assigned in 4 subgroups of 5 individuals, then will attend in 3 stages of psychosocial intervention. First stage contains 1 section in introducing the process. The second stage contains 3 psycho-educational sessions and the third stage contains 2 problem solving sessions. Psychosocial intervention consists of many interventions such as giving insight to family members about the nature and manifestations of schizophrenia, problem solving skills, life skills and communication inside the family.
Category
Rehabilitation
2
Description
Control group does not receive any intervention but they are monitored for comparing with the intervention group.