Objectives: Comparison of family- center and patient- center psycho- education model on drug compliance in patients with mental disorders in Bushehr. Design: Randomized, clinical trial. Setting and conduct: Fifty schizophrenic patients and fifty patients with bipolar disorder were randomly divided into two subgroups separately. One subgroups of patients with schizophrenia and bipolar disorder will be trained through family- center psycho- education model and other subgroups of these patients will be trained through patient- center psycho- education model. Inclusion criteria includes age between 18- 60 years old; diagnosis of schizophrenia and bipolar disorder; according to BMQ questionnaire (Beliefs about medicines questionnaire), drug compliance score less than 5. Exclusion criteria includes start the acute phase of the disease; not participation in more than two training sessions. Interventions: In the first intervention group, patients and one of their family members will be trained through psycho- education model and in the other group, just patients will be trained through psycho- education model. In this model, six weekly sessions will be explained about disorder definition and its causes, the process and prognosis, medications and early identification of disorder. Before, after and one month later Patients' drug compliance will be evaluated by BMQ questionnaire.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201607188473N6
Registration date:2017-01-22, 1395/11/03
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-01-22, 1395/11/03
Registrant information
Name
Masoud Bahreini
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 3836
Email address
m.bahreini@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2017-01-19, 1395/10/30
Expected recruitment end date
2017-02-19, 1395/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between efficacy of family- center and patient- center psycho-education model on drug compliance in patients with mental disorders
Public title
Effect of psycho-education model on drug compliance in patients with mental disorder
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria includes age between 18- 60 years old; diagnosis of schizophrenia and bipolar disorder; according to BMQ questionnaire (Beliefs about medicines questionnaire), drug compliance score less than 5. Exclusion criteria includes start the acute phase of the disease; not participation in more than two training sessions
Age
From 18 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)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Bushehr University of Medical Sciences, Sabz Abad, Bushehr, Iran
City
Bushehr
Postal code
7518759577
Approval date
2016-05-16, 1395/02/27
Ethics committee reference number
IR.BPUMS.REC.1395.22
Health conditions studied
1
Description of health condition studied
Bipolar disorder
ICD-10 code
F31.7
ICD-10 code description
Bipolar affective disorder, currently in remission
2
Description of health condition studied
schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Drug compliance
Timepoint
Before the intervention; after the intervention; one months after the intervention
Method of measurement
Beliefs about medicines questionnaire (BMQ)
Secondary outcomes
empty
Intervention groups
1
Description
Control group: in this group, patient- center psycho- education model will be used in six 90- 120 minute training sessions during six consecutive weeks.In this model just patient will be trained about disorder definition and its causes, the process and prognosis, medications and early identification of disorder.
Category
Other
2
Description
Intervention: in this group, family- center psycho- education model will be used in six 90- 120 minute training sessions during six consecutive weeks.In this model patients and one of their family members will be trained about disorder definition and its causes, the process and prognosis, medications and early identification of disorder.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohada Khalij Fars Hosptal
Full name of responsible person
maryam rahmanian
Street address
Shohada Khalij Fars Hospital Bushehr, Taleghani street, Azadi Square, Bushehr
City
Bushehr
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-chancellor for Research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Sabz Abad, Bushehr, Iran
City
Bushehr
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, Bushehr 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
Bushehr University of Medical Sciences
Full name of responsible person
Maryam Rahmanian
Position
Masters Student of Nursing
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
Email
m.rahmanian93@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Masoud Bahreini
Position
PhD in nursing
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Sabz Abad, Bushehr, Iran
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
Email
msdbahreini@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Masoud Bhareini
Position
PhD of Nursing
Other areas of specialty/work
Street address
Bushehr Univeristy of Medical Sciences, Salman Farsi Street, Sabz Abad ,Bushehr,Iran
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
Email
msdbahreini@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)