The effect of cognitive-behavioral intervention on the burden and quality of life in drug dependence caregivers referred to the Shahid Modarres Hospital
in 2016
The aim of this study was to improve the care givers burden and quality of life on families of drug dependence.This study is a clinical trial, randomized, parallel, double-blind study. In this study, 64 family caregivers of drug dependence who are eligible for inclusion criteria through convenience sampling and randomly divided into two groups and the control group have 8 session intervention. Having at least one drug dependence persons and the ability to participate in the training sessions are the most important criteria to enter the study. If for some reason more than one session of training sessions to care for his absence will be removed. The Zarit questionnaire caregiver burden and World Health Organization Quality of Life Questionnaire of 26 questions (WHOQOL-BREF) is completed by both groups in three stages: before, immediately after and one month after the intervention.By comparing the results of this study at the end, we can measure the effect of cognitive-behavioral intervention on burden and quality of life caregivers and if it was effective , the education can be used.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017011431927N1
Registration date:2017-02-11, 1395/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-02-11, 1395/11/23
Registrant information
Name
Maryam Faghih
Name of organization / entity
Isfahan University of Medical Siences
Country
Iran (Islamic Republic of)
Phone
+98 913 214 2075
Email address
mfaghih@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Siences
Expected recruitment start date
2016-06-21, 1395/04/01
Expected recruitment end date
2016-08-21, 1395/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of cognitive-behavioral intervention on the burden and quality of life in drug dependence caregivers referred to the Shahid Modarres Hospital
in 2016
Public title
The effect of cognitive-behavioral intervention on the burden and quality of life in drug dependence caregivers referred to the Shahid Modarres Hospital
in 2016
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: family caregiver to be considered as primary care and all have to assume his responsibilities; the family have a mental and physical ability to take care of drug dependent persons; wishing to participate in the stud; be able to communicate and follow the rules of the training session; only care chronic condition like drug dependent in the family; able to speak, read and write in Persian language; psychiatric drug and no drug is not consumed; in family training sessions (any other research project in the field) have not participated in the past; care for person of drug dependence who range in age from 18-60 years Drug dependent persons and at least once a history of hospitalization due to drug dependence disorder have; drug dependent persons is not affected with any disease (physical disabilities, mental, etc.). Exclusion criteria: family caregiver are not want to continue to participate in the training session; there is any problem, so be careful not to be able to continue to participate in the study; look out for a maximum of two sessions of the training sessions absence; the physical and psychological problems in family caregivers who can not presence in the meetings.
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
School of Nursing and Midwifery, Isfahan University of Medical Sciences
Street address
Hezar jarib street, Azadi Sq
City
Esfahan
Postal code
Approval date
2016-02-21, 1394/12/02
Ethics committee reference number
IR.MUI.REC.1394.3.974
Health conditions studied
1
Description of health condition studied
Drug dependence
ICD-10 code
F10-19
ICD-10 code description
Mental and Behavioral Disorders due to use of alcohol,opioids,cannabis;sedatives, hypnotics, anxiolytics,cocaine,other stimulants, including caffeine,hallucinogens,nicotine,inhalants and other psychoactive substances and multiple drug use
Primary outcomes
1
Description
Caregiver burden
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
Zarit caregiver burden Questionnaire
Secondary outcomes
1
Description
Quality of Life
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire of 26 questions (WHOQOL-BREF)
2
Description
Quality of Life
Timepoint
Before the intervention, after the intervention, one month after the intervention
Method of measurement
World Health Organization Quality of Life Questionnaire of 26 questions (WHOQOL-BREF)
Intervention groups
1
Description
Researcher set her intervention based on cognitive-behavioral intervention program such as a supportive intervention in 8 sessions (on average) 90 minute classes for drug dependence are family members who are qualified to do.
Category
Other
2
Description
the control group will participate in 3 sessions that organized by fellow researcher, and they will discuss and share their experiences
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Street address
Shahid Modarres Hospital, 18 km of road Isfahan, Najaf Abad (beginning Goldasht)
City
Najaf Abad
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Isfahan University of Medical Siences
Full name of responsible person
Ashraf Kazemi
Street address
Hezar jarib St, Azadi Sq
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Isfahan University of Medical Siences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sience
Full name of responsible person
Saied Pahlavanzadeh
Position
Master of Science in Psychiatric Nursing / Registered Psychiatric Nursing and Midwifery Faculty
Other areas of specialty/work
Street address
Isfahan University of Medical Siences, Hezar jarib St, Azadi Sq