Investigating the effectiveness of psychological training on schizophrenia patients and its feedback on patients and their primary caregivers.
Design
Quasi-experimental intervention with pre-test and post-test with control group. With a sample size of 176 people.The permuted random blocking method is used to do randomization
Settings and conduct
By referring to Ibn Sina hospital clinic in Mashhad, a number of schizophrenic patients and primary caregivers are selected from among the eligible patients. Then they are randomly divided into 2 intervention groups and control group. Blinding is not done in this study. Then only the intervention group will receive the psychological training booklet, they will be supported by phone every two weeks for 12 weeks.
Participants/Inclusion and exclusion criteria
People diagnosed with schizophrenia and aged 18 or older; Primary caregivers who take care of their relative with schizophrenia; All participants must be able to read and write; All participants must consent to participate in this research; Not suffering from learning disabilities; Not suffering from another mental disorder or drug abuse; Living without a caregiver or contact with close people; Primary caregivers who are involved in the care of more than one person suffering from psychological problems
Intervention groups
Only the intervention group will receive the psychological training booklet, they will be supported by phone every two weeks for 12 weeks. Follow-up phone calls are made to their primary caregivers to ensure that they have read and understood the psychological education manual and to allow them to ask questions about the content of the psychological education manual; But the control group will not receive any training.
Main outcome variables
Knowledge about schizophrenia, relapse rate, reduction of schizophrenia symptoms, care burden of primary caregivers of schizophrenia, quality of life
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210515051300N2
Registration date:2023-01-21, 1401/11/01
Registration timing:registered_while_recruiting
Last update:2023-01-21, 1401/11/01
Update count:0
Registration date
2023-01-21, 1401/11/01
Registrant information
Name
Samane Soltanabadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3734 4825
Email address
soltanabadis981@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-01-11, 1401/10/21
Expected recruitment end date
2023-02-10, 1401/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of psycho-education on schizophrenia and their feedback on patients and their primary caregivers
Public title
The effectiveness of psycho-education on schizophrenia and their feedback on patients and their primary caregivers
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
People diagnosed with schizophrenia and aged 18 years or older.
Primary caregivers caring for a relative with schizophrenia.
All participants must be able to read and write.
All participants must consent to participate in this research.
Primary caregivers who are involved in caring for more than one person with mental health problems.
Exclusion criteria:
Having a learning disability
Suffering from another mental disorder or substance abuse
Life without a caregiver or contact with close people
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
176
Randomization (investigator's opinion)
Randomized
Randomization description
Permutation random block method is used for random allocation. In this method, 44 blocks of 4 will be randomly selected from the combination of letters A and B. These blocks are AABB, ABBA, BBAA, BAAB, ABAB, BABA. Allocation of letters A and B to the intervention and control groups will also be done randomly before randomization.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
Khaghani 19, No. 192
City
Mashhad
Province
Razavi Khorasan
Postal code
9146784698
Approval date
2022-11-15, 1401/08/24
Ethics committee reference number
IR.MUMS.MEDICAL.REC.1401.554
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Awareness of schizophrenia disorder
Timepoint
Beginning and end of the study
Method of measurement
Knowledge Questionnaire about Schizophrenia (KASQ)
2
Description
The rate of disease recurrence
Timepoint
Beginning and end of the study
Method of measurement
Sign test
3
Description
Reduction of disease symptoms
Timepoint
Beginning and end of the study
Method of measurement
Positive and Negative Symptom Scale Questionnaire in Schizophrenias (PANSS)
4
Description
Caring burden of primary caregivers of schizophrenia
Timepoint
Beginning and end of the study
Method of measurement
Family Interview Scale (FBIS)
5
Description
Quality of life of primary caregivers of schizophrenia
Timepoint
Beginning and end of the study
Method of measurement
Quality of life scale (S-CQOL)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Only the intervention group will receive the psychological training booklet, they will be supported by phone every two weeks for 12 weeks. Follow-up phone calls are made to their primary caregivers to ensure that they have read and understood the psychological education manual and to allow them to ask questions about the content of the psychological education manual.The content of each psychological training manual includes information on diagnosis, symptoms, coping with symptoms, treatment options, and how to solve problems and identify stressors for people with schizophrenia.
Category
Rehabilitation
2
Description
Control group: They do not receive any intervention.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
EbneSina Hospital and Psychiatric Training Center
Full name of responsible person
Samane Soltanabadi
Street address
Bo Ali Square, Horameli Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
66373_91949
Phone
+98 51 3711 2701
Email
samane.soltanabadi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohsen Taqfadi
Street address
Khorasan Razavi, Mashhad
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
tafaghodim@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
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
Mashhad University of Medical Sciences
Full name of responsible person
Samane Soltanabadi
Position
phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khaghani19
City
Mashhad
Province
Razavi Khorasan
Postal code
9146784698
Phone
+98 51 3734 4825
Email
samane.soltanabadi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Soltanabadi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khaghani19
City
Mashhad
Province
Razavi Khorasan
Postal code
9146784698
Phone
+98 51 3734 4825
Email
samane.soltanabadi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Samane Soltanabadi
Position
Ph.D student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khaghani19
City
Mashhad
Province
Razavi Khorasan
Postal code
9146784698
Phone
+98 51 3734 4825
Email
samane.soltanabadi@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Information on the main outcomes can be shared.
When the data will become available and for how long
The information will be published after analyzing the data and printing the results.
To whom data/document is available
researchers
Under which criteria data/document could be used
.
From where data/document is obtainable
Samane Soltanabadi
samane.soltanabadi@gmail. com
What processes are involved for a request to access data/document