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The effect of quality of life therapy on stress, burden and life satisfaction in family caregivers of addicts

Protocol summary

Study aim
Determining the effect of quality of life therapy on stress, psychological burden and family satisfaction of addicts referring to Zahedan Psychiatric Hospital in 2018
Design
In this study, 80 family caregivers of addicts referred to Zahedan Psychiatric Hospital who have entrance requirements are selected and divided into two groups of intervention and control in simple random order.
Settings and conduct
Both intervention and control groups performed pretest tests by completing psychological burden, stress and life satisfaction questionnaires. The intervention group will receive 7 sessions of quality of life therapy education based on the content specified in the hospital's educational class.
Participants/Inclusion and exclusion criteria
Career Entry Criteria: A member of the family who has all the health, medical, care and support responsibilities of the patient, Having a minimum degree of guidance, Resident in Zahedan City, The carer is the only caregiver of a patient. Addict entry criteria: The primary and primary diagnosis of drug dependence, Absence of psychiatric disorders, Having a minimum age of 20 and a maximum of 50 years, Life in the family Watch out for departure criteria: An extreme incident one month before the time of the study, having acute psychological problems and addiction
Intervention groups
The intervention group will receive 7 sessions of quality of life therapy within one day, 90 minutes, and based on specified content. Four weeks after the end of the intervention, the post-test will be performed. The control group does not receive counseling and training during this period. And the educational content will be provided to the family carers of the control group.
Main outcome variables
burden, stress and life satisfaction

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160924029954N11
Registration date: 2018-09-04, 1397/06/13
Registration timing: prospective

Last update: 2018-09-04, 1397/06/13
Update count: 0
Registration date
2018-09-04, 1397/06/13
Registrant information
Name
Ali navidian
Name of organization / entity
Zahedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3344 2482
Email address
alinavidian@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-09-11, 1397/06/20
Expected recruitment end date
2018-11-11, 1397/08/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of quality of life therapy on stress, burden and life satisfaction in family caregivers of addicts
Public title
The effect of quality of life therapy on burden in family caregivers of addicts
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
A member of the family who has all the health, medical, care and support responsibilities of the patient. Having a minimum degree of middle school Resident in Zahedan City The carer is the only caregiver of a patient
Exclusion criteria:
having acute psychological problems and addiction a mishap one month before the study
Age
From 20 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were randomly assigned into two intervention and control groups and the randomized sealed envelope was used.
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 Zahedan University of Medical Sciences & Health Services
Street address
Administrative Complex of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
98167-43463
Approval date
2018-07-15, 1397/04/24
Ethics committee reference number
IR.ZAUMS.REC.1397.194

Health conditions studied

1

Description of health condition studied
Psychiatric condition of addict carers
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
subjective burden
Timepoint
Before intervention and one month after intervention
Method of measurement
Burden questionnaire

2

Description
Stress
Timepoint
Before intervention and one month after intervention
Method of measurement
Stress Beck Questionnaire

3

Description
Life satisfaction
Timepoint
Before intervention and one month after intervention
Method of measurement
Life satisfaction questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will receive 7 sessions of quality of life therapy within one day, 90 minutes, and based on the specified content.
Category
Other

2

Description
Control group: Control group: During this period, the control group does not receive any counseling and training. At that same interval, the post-test intervention group is also done. Educational content will be provided to the family carers of the control group.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Zahedan Psychiatric Hospital
Full name of responsible person
Zahra Karimi
Street address
Baharan Psychiatric Hospital, Imam Khomeini Street
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916713335
Phone
+98 54 3722 2364
Email
karimi.nursezahra@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Nour Mohammad Bakhshani
Street address
Administrative Complex of Zahedan Medical Science Campus، Persian Gulf Blvd، Dr. Hesabi Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916713335
Phone
+98 54 3721 2364
Email
karimi.nursezahra@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Zahra Karimi
Position
Master Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery، Mashahir Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916713335
Phone
+98 54 3721 2364
Email
Krimi.nursezahra@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Ali Navidian
Position
Ph.D.
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Faculty of Nursing and Midwifery, Mashahir Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9816743463
Phone
+98 54 3344 2482
Email
alinavidian@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Zahra karimi
Position
Master Student in Psychiatric Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Faculty of Nursing Midwifery، Mashahir Square، Zahedan
City
Zahedan
Province
Sistan-va-Balouchestan
Postal code
9916713335
Phone
+98 54 3721 2364
Email
karimi.nursezahra@gmail.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
Participants information is confidential
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
En the method of implementation of the plan is explained in the thesis
When the data will become available and for how long
The post-graduation study protocol is described in the thesis
To whom data/document is available
Researchers working in academia and academia
Under which criteria data/document could be used
There are no special conditions
From where data/document is obtainable
The thesis is explained
What processes are involved for a request to access data/document
There is no plan to publish it
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