Determining the Effect of coping strategies training on caregiver' care burden and anxiety in Family caregivers of patients with mental disorder
Design
A clinical trial with a control group, with parallel group design, without blindness, randomized through a random numbers table
Settings and conduct
This study was conducted in the psychiatric ward of Atieh Hospital in Tehran. Using available sampling method, individuals were selected and randomly assigned into intervention and control groups. The samples of both groups completed Zarit's Burden questionnaire and Spielberg's Clear Anxiety Questionnaire. For the intervention group, training sessions were conducted in eight sessions. The post-test was taken one month after the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Consent to participate in research and having cooperation; having a family relationship with the patient with mental disease; Minimum age of 20 and maximum age of 60 years old; Having at least 6 months of patient care history.
Non Inclusion criteria: participation in previous same educational program in Last three months; take care of a patient with other chronic conditions
Intervention groups
Intervention group: For the intervention group, an educational program is implemented including 1. Identify and define the problem 2. Need help during problems 3. Identify measures to help solving problems 4. Identify possible barriers to the care plan 5. Set up an app for caregivers. In intervention group, there are 8 60-minute training sessions (two sessions a week) will be performed. Control group: The control group receive routine care.
Main outcome variables
Care burden; Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181209041907N1
Registration date:2019-01-08, 1397/10/18
Registration timing:retrospective
Last update:2019-01-08, 1397/10/18
Update count:0
Registration date
2019-01-08, 1397/10/18
Registrant information
Name
Razieh Mehranian
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2218 0036
Email address
ra.mehranian@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-23, 1397/06/01
Expected recruitment end date
2018-12-11, 1397/09/20
Actual recruitment start date
2018-12-10, 1397/09/19
Actual recruitment end date
2018-12-11, 1397/09/20
Trial completion date
2018-12-11, 1397/09/20
Scientific title
Effect of coping strategies training on caregiver's burden of care and anxiety in Family caregivers of patients with mental disorder
Public title
Effect of coping strategies training on caregiver burden and anxiety
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Consent to participate in research and having cooperation
Ability to communicate effectively with researcher
ability to handle meetings and prepared to respond to questions physically and mentally
Having a family relationship with a mental patient
Minimum 20 and maximum 60 years old
having the ability to read and write
Have at least 6 months of patient care history
Exclusion criteria:
participation in previous same educational program in Last three months
take care of a patient with other chronic conditions
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Table of random numbers was used for randomization
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 University of Social welfare and Rehabilitation Sciences
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Approval date
2018-04-28, 1397/02/08
Ethics committee reference number
IR.USWR.REC.1396.172
Health conditions studied
1
Description of health condition studied
Schizophrenia
ICD-10 code
F20.9
ICD-10 code description
Schizophrenia, unspecified
Primary outcomes
1
Description
Care burden
Timepoint
Before and one month after Intervention
Method of measurement
Zarit's Burden questionnaire
2
Description
Anxiety
Timepoint
Before and one month after intervention
Method of measurement
Spielberg's Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: For the intervention group, an educational program is implemented including 1. Identify and define the problem 2. Need help during problems 3. Identify measures to help to solve problems 4. Identify possible barriers to the care plan 5. Set up an app for caregivers. In the intervention group, there are 8 60-minute training sessions (two sessions a week) will be performed.
Category
Behavior
2
Description
Control group: Only routine care and training were provided for the control group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Atieh Hospital
Full name of responsible person
Razieh Mehranian
Street address
Farahzadi Blvd, Qods Town, Tehran
City
Tehran
Province
Tehran
Postal code
1467773661
Phone
+98 21 8858 0048
Email
Atiehhospital@yahoo.com
Web page address
https://www.atiehhospital.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Hamidreza Khankeh
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
mehranianrazeye@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of social welfare and rehabilitation 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
University of social welfare and rehabilitation sciences
Full name of responsible person
Razieh Mehranian
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
mehranianrazeye@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Abolfazl Rahgoi
Position
Associated Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
Tehran
Province
Tehran
Postal code
1985713834
Phone
+98 21 2218 0036
Email
rahgouin@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
University of social welfare and rehabilitation sciences
Full name of responsible person
Razieh Mehranian
Position
Nurse
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Koodakyar Avenue, Daneshjoo Blvd, Evin, Tehran
City
tehran
Province
Tehran
Postal code
1985713834
Phone
+98 212218003
Email
mehranianrazeye@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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be 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