A Clinical Trial to assess the Effectiveness of Family-Based Interventions on Severity of Symptoms, Stigma, Caregiver Burden, Emotion Expression and Coping Styles among Family Members of Bipolar Patients.
This research is an experimental research. It evaluates the effectiveness of family-based Interventions on family members of Bipolar Patients. The research aims to deliver a therapeutic guideline based on Iranian culture. Sixty subjects from family members and caregivers of patients with bipolar spectrum disorders are randomly selected. Their diagnosis has been confirmed by psychiatrist. Family member has no considerable mental disorder, has at least primary school education, and is in age range of 25-60 years old. For randomization, all patients who met inclusion criteria are selected and a code is specified to each patient. By randomly drawing, patients will be allocated to intervention and control groups and will participate in group therapy sessions after filling the written consent form. Group therapy sessions will be applied to one of the family members who has the most contact with patient, in 12 sessions within 4 weeks and is based on Micklowitz package adapted for Iranian culture. Young Mania Rating Scale (YMRS), Zarit Caregivers Burden Inventory, Stigma, Emotion Expression Questionnaire (EEQ) and Coping Inventory for Stressful Situations (CISS) will be completed by family members before, at the end and after 3 months of therapy sessions termination.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017061434533N1
Registration date:2017-09-25, 1396/07/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-09-25, 1396/07/03
Registrant information
Name
Neda Ali Beigi
Name of organization / entity
University of Social Welfare and Rehabilitation Sciences.
Country
Iran (Islamic Republic of)
Phone
+98 21 8876 1317
Email address
ne.alibeigi@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation Sciences
Expected recruitment start date
2016-03-19, 1394/12/29
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Clinical Trial to assess the Effectiveness of Family-Based Interventions on Severity of Symptoms, Stigma, Caregiver Burden, Emotion Expression and Coping Styles among Family Members of Bipolar Patients.
Public title
Effectiveness of Family-Based Interventions on Family Members of Bipolar Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of Bipolar Disorder based on DSM–IV-TR (American Psychiatric Association, 2000) and psychiatrists’ diagnostic interview; the Bipolar Disorder diagnosis should be confirmed by SCID (Structured clinical interview); The age range of 25 to 60 years old; Family member should be educated at least 8 grades; Patient should live with the family member before and after hospitalization; The family member should be psychological minded and should have enough eager and ability to understand therapeutic constructs.
Exclusion criteria: The group participant has considerable mental disorder diagnosis that report in axis I in DSM-IV-TR diagnostic classification.
Age
No age limit
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
For randomization all patients who met inclusion and exclusion criteria will select and we specify a code to each patient. Through drawing randomly by a blind person to purpose of study, patients allocate to intervention and control group.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of University of Social Welfare and Rehabilitation Sciences
Street address
University of Social Welfare and Rehabilitation Sciences, Kodakyar st., Daneshjoo Blv, Velenjak.
City
Tehran
Postal code
Approval date
2016-10-01, 1395/07/10
Ethics committee reference number
IR.USWR.REC.1395.166
Health conditions studied
1
Description of health condition studied
Bipolar Disorder
ICD-10 code
F31
ICD-10 code description
Bipolar affective disorder
Primary outcomes
1
Description
caregiver burden
Timepoint
before intervention, after intervention, 3months follow-up
Method of measurement
Zarit Caregiver Burdun Inventory
2
Description
stigma
Timepoint
before intervention, after intervention, 3months follow-up
Method of measurement
Michel King Stigma Inventory
3
Description
coping styles
Timepoint
before intervention, after intervention, 3months follow-up
Method of measurement
CISS- Coping Inventory in stressful Situations
4
Description
emotion expression
Timepoint
before intervention, after intervention, 3months follow-up
Method of measurement
Emotional Expressiveness Questionnaire EEQ
5
Description
bipolar disorder symptoms
Timepoint
before intervention, after intervention, 3months follow-up
Method of measurement
YMRS Young mania rating scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Family members will receive family- based psychotherapy within 3 10-member groups. Family based psychotherapy consists of 12 session. The duration of each session is 90 minutes. The sessions contain these topics: knowledge about the disease, bio-psycho-social model, symptoms of bipolarity, mood stabilizer medications, medication compliance, knowledge about mood swings, how to apply mood graphs, relation between mood and situations, family members as predisposing events, reviewing the level of activity, regulating restrictions before reaching problematic level, crisis management and problem solving, family members tension reduction practices and relapse prevention.
Category
Behavior
2
Description
Control Group: It consist of family members of patients with bipolar spectrum disorders. They will not receive intervention. They only complete questionnaires on pretest, post test and follow-up.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Psychiatric Hospital
Full name of responsible person
Dr Mohammad Sayad Nasiri
Street address
Psychosis Research Center, Chahardehi Building, Razi Psychiatry Center, Amin Abad, Shahr- Rey.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Social Welfare and Rehabilitation Sciences University.
Full name of responsible person
Dr. Yadegari, Fariba.
Street address
Vice Chancellor for Research, University of Social Welfare and Rehabilitation Sciences, Kodakyar st., Daneshjoo Blv, Velenjak, Tehran.
City
Tehran
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 of Social Welfare and Rehabilitation Sciences University.