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Effectiveness of gratitude program on psychological well-being and quality of life among substance abuse patients

Protocol summary

Study aim
A gratitude program based on research findings will be used to improve the quality of life and psychological well-being of substance dependent patients in order to improve the quality of life and psychological well-being of drug dependent patients by using an appropriate and accessible method.
Design
For randomization, two small red (test) and blue (control) balls in a bag were used and the subjects were tested and controlled without knowledge. The randomization unit was simple and none of the participants and nurses of the team were familiar with the test and control groups. The study is a blind and parallel strain.
Settings and conduct
The research was conducted on 64 addicted patient which had been referred to the addiction rehabilitation center (Modarres hospital) of Isfahan city, that divided to two groups that each one included 32 patients.GQ-6, WHOQOL, and WHO-6 questionnaires used for estimate of gratitude, QoL, and well-being scores respectively. The SPSS 16 software was used for analyzing the collected data. The study is a blind and only participants and nurses and researcher were unaware of the test and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Literacy, lack of psychological services, No mental disorders, Have not any disability Exclusion criteria: unwillingness to intervention, absences during meetings, the occurrence of abnormal stress during and the six months prior to the study
Intervention groups
In order to evaluate the gratitude program on the well-being and quality of life on hospitalized substance abuse dependent, two groups of 32 patients (test and control) were selected and studied.
Main outcome variables
Gratitude program, Well-being, Quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180124038495N1
Registration date: 2018-03-10, 1396/12/19
Registration timing: retrospective

Last update: 2018-03-10, 1396/12/19
Update count: 0
Registration date
2018-03-10, 1396/12/19
Registrant information
Name
Maryam Jamshidian Ghalesefidi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 4224 1862
Email address
mehdi.azami@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-12-22, 1395/10/02
Expected recruitment end date
2017-04-25, 1396/02/05
Actual recruitment start date
2016-12-22, 1395/10/02
Actual recruitment end date
2017-04-25, 1396/02/05
Trial completion date
empty
Scientific title
Effectiveness of gratitude program on psychological well-being and quality of life among substance abuse patients
Public title
The role of gratitude on psychological well-being and quality of life in patients with substance abuse dependence
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Ability to read and write No mental disorder that is characterized reviewing patient records. No received a recent psychology treatment support (behavioral or recognition therapy) during the intervention stages Not any disability
Exclusion criteria:
An unwillingness to continue the intervention. Absence in meetings for 2 sessions The occurrence of abnormal stresses of "life crisis" during and six months before the study
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
Sample size
Target sample size: 64
Actual sample size reached: 64
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization Method: Simple Randomization unit: Individual Randomization Tool: Use two small red balls (test group) and blue (control group) inside a bag
Blinding (investigator's opinion)
Single blinded
Blinding description
The participants were aware of the study, ذut in which group (test or control) they were completely unaware. Also, collaborative nurses and researcher were unaware of this trend.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Department of Psychiatric Nursing, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
۸۱۷۴۶۷۳۴۶۵
Approval date
2016-12-21, 1395/10/01
Ethics committee reference number
395606

Health conditions studied

1

Description of health condition studied
Addiction
ICD-10 code
F-11.2
ICD-10 code description
F10 Mental and behavioural disorders due to use of opioids

Primary outcomes

1

Description
The percentage of participants whose gratitude score is high.
Timepoint
At the start of the study and one month after the start of the study
Method of measurement
GQ-6 used for estimate of gratitude scores.

Secondary outcomes

1

Description
Quality of life
Timepoint
At the start of the study and one month after the intervention
Method of measurement
WHOQOL questionnaire

2

Description
Well being
Timepoint
At the start of the study and one month after the intervention
Method of measurement
WHO-6 questionnaire

Intervention groups

1

Description
The intervention group (test) was evaluated using a questionnaire at the beginning of the examination of the test. The quality of life and well-being of these individuals were evaluated by WHOQOL-BREF and WHO-6 standard questionnaires. During a month, four counseling sessions and a presentation of gratitude program were completed and at the end of a month using standard questionnaires WHOQOL-BREF and WHO-6, the quality of life and well-being of these individuals were re-evaluated and compared with the initial stage of the study. The GQ-6 questionnaire was used at the end of the month to determine the effect of gratitude program. Intervention results were collected, analyzed and compared with control group during 1 month.
Category
Behavior

2

Description
Control group: The control group was evaluated using a questionnaire at the beginning of the examination of the test. The quality of life and well-being of these individuals were evaluated by WHOQOL-BREF and WHO-6 standard questionnaires. During a month, four counseling sessions and a presentation of gratitude program were completed and at the end of a month using standard questionnaires WHOQOL-BREF and WHO-6, the quality of life and well-being of these individuals were re-evaluated and compared with the initial stage of the study. The GQ-6 questionnaire was used at the end of the month to determine the effect of gratitude program. Intervention results were collected, analyzed and compared with Intervention group during 1 month.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Modarres Psychiatric Hospital
Full name of responsible person
Hamid Mohammad Beighi
Street address
Modarres hospital, Emam street, Gholdasht
City
gholdasht
Province
Isfehan
Postal code
8583151351
Phone
+98 31 4223 2385
Email
mjamshidian100@gmail.com
Web page address
http://modarres.mui.ac.ir/Contact

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shahnaz Kohan
Street address
Department of Psychiatric Nursing, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Hezar Jarib street, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
8174673465
Phone
+98 31 3792 7532
Email
kohan@nm.mui.ac.ir
Web page address
http://nm.mui.ac.ir/fa/%D9%85%D8%B9%D8%A7%D9%88%D9%86-%D9%BE%DA%98%D9%88%D9%87%D8%B4%DB%8C
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Jamshidian Ghalesefidi
Position
MSc. student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Dept., Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4224 1862
Fax
Email
mjamshidian100@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Jamshidian Ghalesefidi
Position
MSc. student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Dept., Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4224 1862
Fax
Email
mjamshidian100@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Maryam Jamshidian Ghalesefidi
Position
MSc. student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nursing and Midwifery Dept., Isfahan University of Medical Sciences, Hezar Jarib street
City
Isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 4224 1862
Fax
Email
mjamshidian100@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
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
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
By publishing the data and the items mentioned in the dissertation, we will apply the valid scientific articles to the publication of the data.
When the data will become available and for how long
Start accessing data is two months after printing results
To whom data/document is available
All interested persons
Under which criteria data/document could be used
The use of study data for the purpose of scientific development in all fields is permissible.
From where data/document is obtainable
Department of Psychiatric Nursing, Faculty of Nursing and Midwifery, Isfahan University of Medical Sciences, Isfahan, Iran Maryam Jamshidian Ghalesefidi: 09132897467
What processes are involved for a request to access data/document
Usually three days after data call, data can be transferred.
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