Health Improvement in caregivers of patients with scizophrenia
Design
This study will be a randomized clinical trial with a four-group solomon design, involving 72 participants, each group with 18 participants. In this way, after selecting the individuals who meet eligibility criteria, the allocation of participants to two groups will be done by simple randomization using a table of random numbers. Again, in the same way, each group's individuals are assigned to the intervention and control groups. The per-test will be held for the intervention group1 and control group1. Intervention groups will receive intervention program in addition to routine care. During the study, the control groups will receive only regular care. In the end, the post-test will be performed for all four groups.
Settings and conduct
Individual counseling- EbneSina psychiatric Hospital in Shiraz, Affiliated to Shiraz University of Medical Sciences.
Participants/Inclusion and exclusion criteria
Participants are caregivers of patients with schizophrenia;
inclusion criteria: Over 18 years old, Main family caregiver of patients with schizophrenia for at least one year;
Exclusion criteria: Unable to understand the study procedures; Under treatment for mental illnesses.
Intervention groups
Intervention group1: include five sessions of 1.5 to two hours of individual counseling with aiming identifying and satisfying the health needs; Intervention group 2: five sessions of 1.5 to two hours of individual counseling with aiming identifying and satisfying the health needs. Control group1: will receive routine care during the study; Control group 2: receive routine care during the study.
Main outcome variables
Outcomes will include improving well-being and reducing the burden of care in caregivers of patients with schizophrenia.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20111105008011N2
Registration date:2021-04-11, 1400/01/22
Registration timing:prospective
Last update:2021-04-11, 1400/01/22
Update count:0
Registration date
2021-04-11, 1400/01/22
Registrant information
Name
shahpar Bagheri
Name of organization / entity
Shiraz university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1647 4254
Email address
shbagheri@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-21, 1400/02/01
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating of Health Improvement Program in Caregivers of Patients with Schizophrenia based on Watson’ Theory
Public title
Evaluating of Health Improvement Program in Caregivers of Patients with Schizophrenia based on Watson’ Theory
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Over 18 years old
Main family caregiver of patients with schizophrenia for at least one year
Exclusion criteria:
Unable to understand the study procedures
Under treatment for mental illnesses
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
First, we will contact individuals who meet eligibility criteria from whose information is recorded in the psychiatric center. We will invite 72 people to a briefing session and obtaining informed consent. (the number of participants has been calculated with the Med-calc statistical software with 80% power and 5% error and considering a possible drop of 20%). In the next step, we will consider a cod for each person. Then, for a simple random assignment with a random number table, participants are divided into two groups (by starting sampling from a point on the right side of a line of the table based on a random sequence such as even and odd numbers). Again, the two groups will randomly be divided into intervention and control groups (Solomon four-group design). In this way, we will have four groups of 18 people (two intervention groups and two control groups).
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 Shiraz University of Medical Sciences
Street address
School of Nursing and Midwifery, Nemazee Square, Zand St.
City
Shiraz
Province
Fars
Postal code
71936-13119
Approval date
2019-06-09, 1398/03/19
Ethics committee reference number
IR.SUMS.REC.1398.574
Health conditions studied
1
Description of health condition studied
Caregivers of schizophrenia patients
ICD-10 code
F20
ICD-10 code description
Schizophrenia
Primary outcomes
1
Description
Well-being
Timepoint
Before and four weeks after the intervention
Method of measurement
Caregiver well-being Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: The intervention program includes 5 sessions of 1.5 to two hours of individual counseling in 5 weeks. Session 1: Aiming to improve self-awareness by teaching mindfulness, self-reflection, and time diary; Session 2: Identifying and Satisfying Psychological needs by training: Stress Management, Problem Solving; Session 3: Identifying and meeting physical needs: self-care and lifestyle promotion; Session 4: Identifying and Satisfying family and social communication needs: teaching communication skills, promote coexistence; Session 5: Management of schizophrenia. The participant is required to record her/his experiences and performance in the worksheet. The worksheets will be reviewed and given feedback in the next session.
Category
Lifestyle
2
Description
Intervention group 2: The intervention program includes 5 sessions of 1.5 to two hours of individual counseling in 5 weeks. Session 1: Aiming to improve self-awareness by teaching mindfulness, self-reflection, and time diary; Session 2: Identifying and Satisfying Psychological needs by training: Stress Management, Problem Solving; Session 3: Identifying and meeting physical needs: self-care and lifestyle promotion; Session 4: Identifying and Satisfying family and social communication needs: teaching communication skills, promote coexistence; Session 5: Management of schizophrenia. The participant is required to record her/his experiences and performance in the worksheet. The worksheets will be reviewed and given feedback in the next session.
Category
Lifestyle
3
Description
Control group 1: During the study, control group will receive only routine care. After the study, the intervention program will be provided to the control group.
Category
Lifestyle
4
Description
Control group 2: During the study, control group will receive only routine care. After the study, the intervention program will be provided to the control group.
Category
Lifestyle
Recruitment centers
1
Recruitment center
Name of recruitment center
Ebnesina Hospital
Full name of responsible person
Shahpar Bagheri
Street address
Hafez street
City
Shiraz
Province
Fars
Postal code
۷۶۵۴۱-۷۱۴۶۶
Phone
+98 71 3228 9601
Fax
+98 71 3228 0236
Email
sinahosp@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Deputy of research, Shraz University of Medical Sciences
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶ - ۷۱۳۴۸
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Shahpar Bagheri
Position
Nursing PhD Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zand Street
City
Shiraz
Province
Fars
Postal code
713451359
Phone
(+98 71) 36 47 42 54-8
Email
shbagheri@sums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ladan Zarshenas
Position
Associate Professor of Medical and Nursing Education
Latest degree
Ph.D.
Other areas of specialty/work
Medical Education
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
713451359
Phone
(+98 71) 36 47 42 54-8
Email
zarshenasster@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Shahpar
Position
Ph.D Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Zand street
City
Shiraz
Province
Fars
Postal code
713451359
Phone
(+98 71) 36 47 42 54-8
Email
shbagheri@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Yes - There is a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
IPD, Analysis, Clinical trial study report
When the data will become available and for how long
From one month after the end of the study
To whom data/document is available
Researchers and Clinical Practitioners
Under which criteria data/document could be used
For clinical and research use
From where data/document is obtainable
Ladan Zarshenas
What processes are involved for a request to access data/document