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The impact of family-centered group training based on the Atkinson-Coia model on the relapse and severity of symptoms in schizophrenic patients

Protocol summary

Study aim
The effect of family-centered group education (based on Atkinson and coia model) on recurrence and severity of symptoms in schizophrenic patients admitted
Design
A randomized clinical trial, intervention and control groups, and sample size in each group: 50 patients.
Settings and conduct
This study was performed on 100 patients with schizophrenia in Qazvin 22 Bahman psychiatric hospital. The intervention group received their training from a psychiatric nurse. Before and after training sessions (6 months on a monthly basis), severity of symptoms was measured using PANSS questionnaire. Data were compared in different months in both groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria included definitive diagnosis of schizophrenia based on a psychiatrist's diagnosis, having at least one primary caregiver with no communication disorder and no prior psychiatric training. Exclusion criteria for the study were the dissatisfaction of the patient's primary caregiver to attend the training sessions or not to attend more than one.
Intervention groups
In the intervention group, in addition to drug therapy, family group training sessions, with the presence of the patient's primary caregiver, were held in three weekly sessions and each session for 90 minutes. The topics discussed at the meetings were in accordance with the Atkinson and Coia model. Important issues such as complete information about schizophrenia, relapse symptoms, treatments, patient-family, family and schizophrenia, rehabilitation, support organizations, and patient care. At the end of each session a question and answer session was conducted.In the control group only the usual drug therapy was unchanged and no educational intervention was performed.
Main outcome variables
Decrease in readmission; Decrease in patient-caregiver involvement; Increase in family awareness

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200220046561N1
Registration date: 2020-03-12, 1398/12/22
Registration timing: retrospective

Last update: 2020-03-12, 1398/12/22
Update count: 0
Registration date
2020-03-12, 1398/12/22
Registrant information
Name
Nasser Hajiaghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 28 3368 5170
Email address
nhajiaghaee@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-06-17, 1396/03/27
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
2017-06-17, 1396/03/27
Actual recruitment end date
2018-03-19, 1396/12/28
Trial completion date
2018-05-02, 1397/02/12
Scientific title
The impact of family-centered group training based on the Atkinson-Coia model on the relapse and severity of symptoms in schizophrenic patients
Public title
The impact of family-centered group training based on the Atkinson-Coia model on the relapse and severity of symptoms in schizophrenic patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of schizophrenia based on psychiatric diagnosis Having at least one primary caregiver with no communication impairment and no prior psychiatric training
Exclusion criteria:
The patient's primary caregiver's dissatisfaction with continuing to attend training sessions Absence of the patient's primary caregiver in more than one session of training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 100
Actual sample size reached: 100
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized simple: Samples were divided into experimental and intervention groups by lottery (red and blue sheets).
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
Ethics committee of Qazvin University of Medical Sciences
Street address
No92, 33 َAve,Shahid babaie Blvd, Qazvin Town
City
Qazvin
Province
Qazvin
Postal code
3414678113
Approval date
2017-06-08, 1396/03/18
Ethics committee reference number
IR.QUMS.REC.1395.34

Health conditions studied

1

Description of health condition studied
Severity of symptoms and Relapse of schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia

Primary outcomes

1

Description
Relapse of schizophrenia
Timepoint
6 and 9 months after the training program
Method of measurement
PANSS questionnaire

2

Description
Severity of the symptoms of schizophrenia
Timepoint
6 and 9 months after the training program
Method of measurement
PANSS questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Family-centered group training based on the Atkinson-Coia model
Category
Rehabilitation

2

Description
Control group: Drug therapy, without medication changes
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Qazvin 22 Bahman Hospital
Full name of responsible person
Mohamad Reaz Sheikhi
Street address
Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3334 4504
Email
mmsheikhi1@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Sheikhi‏
Street address
Bahonar Blvd, Qazvin University Of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3334 4504
Email
mmsheikhi1@yahoo.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
60
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
Mohammad Reza Sheikhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Bahonar Blvd, Qazvin University of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
1531534199
Phone
+98 28 3334 4504
Email
mmsheikhi1@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Nasser Hajiaghaei
Position
Emergency Response
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Rahahan Blvd, Pastor Ave, 22 bahman hospital
City
Qazvin
Province
Qazvin
Postal code
3414678113
Phone
+98 28 3355 5978
Email
nhajiaghaee@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Qazvin University of Medical Sciences
Full name of responsible person
Mohammad Reza Sheikhi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Bahonar Blvd, Qazvin University Of Medical Sciences
City
Qazvin
Province
Qazvin
Postal code
1531534199
Phone
0098283344504
Email
mmsheikhi1@yahoo.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
Mental patient information is completely confidential
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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