Protocol summary

Study aim
To determine the effectiveness of cognitive-behavioral training based on immunization against stress on increasing coping skills and quality of life in maladjusted couples
Design
In this study, 24 maladjusted couples who had referred to counseling centers were selected and randomly assigned to two experimental and control groups
Settings and conduct
This study was conducted in Kazeroun
Participants/Inclusion and exclusion criteria
Participants were selected based on perceived stress and marital adjustment
Intervention groups
The experimental group consisted of 12 couples who received anti-stress immunization training. The control group also included 12 couples who did not receive any intervention.
Main outcome variables
Immunization intervention is effective in improving quality of life in couples and increases their problem-oriented coping style.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20160721029019N2
Registration date: 2018-06-17, 1397/03/27
Registration timing: retrospective

Last update: 2018-06-17, 1397/03/27
Update count: 0
Registration date
2018-06-17, 1397/03/27
Registrant information
Name
Zahra Simi
Name of organization / entity
Allameh Tabatabei University
Country
Iran (Islamic Republic of)
Phone
+98 71 4252 4840
Email address
z.simin00@yahoo.com
Recruitment status
Recruitment complete
Funding source
investigator
Expected recruitment start date
2016-08-22, 1395/06/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of cognitive-behavioral training based on immunization against stress on increasing coping skills and quality of life in maladjusted couples
Public title
The effectiveness of cognitive behavioral training based on immunization against stress
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Having a standard deviation higher than the mean in perceived stress Having a score below 101 in marital adjustment
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Twenty-four couples were selected and randomly divided into two experimental and 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
Allameh Tabatabaei University.
Street address
Olympic Village, Hemmat Exp way, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
7351737966
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
2048197

Health conditions studied

1

Description of health condition studied
The effectiveness of cognitive behavioral training based on immunization against stress on creasing coping skills and life quality in maladjusted couples
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Quality of life
Timepoint
Pre, post test and follow up
Method of measurement
Questionnaire

Secondary outcomes

1

Description
Coping skills
Timepoint
Pre post & follow up
Method of measurement
Questionnaire

Intervention groups

1

Description
The control group received no training but after completing the research period, the members of the control group received practical training packages based on stress-management immunization training.
Category
Behavior

2

Description
The experimental group received 10 sessions of interventions and then received an independent variable in the stress-safety approach for 60 minutes. Data were collected by the Coping Styles Questionnaire of Endler & Parker, Cohen's Perceived Stress, and Quality of Life SF-36 in two stages: pre-test and post-test
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Counselling Offices
Full name of responsible person
Zahra Simi
Street address
Rahesevom Counselling Offices, Kazeroun, Fars, Iran.
City
Kazeroun
Province
Fars
Postal code
7131723559
Email
z.simin62@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Researcher
Full name of responsible person
Zahra Simi
Street address
Social Welfare Bureau, Street rally
City
kazroun
Province
Fars
Postal code
7131723559
Phone
+98 71 2221 9990
Email
sadrahm2014@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Researcher
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Allameh Tabatabaei university.
Full name of responsible person
Zahra Simi
Position
M. Sc
Latest degree
Master
Other areas of specialty/work
Street address
Kazerun branch of Payame Noor university, Kazeroun, Fars, Iran.
City
Kazeroun
Province
Fars
Postal code
7351737966
Phone
+98 71 4253 0986
Fax
Email
z.simin00@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Allameh Tabatabaei University.
Full name of responsible person
Zahra Simi
Position
M. Sc.
Latest degree
Master
Other areas of specialty/work
Street address
Kazerun branch of Payame Noor university, Kazeroun, Fars, Iran.
City
Kazeroun
Province
Fars
Postal code
7351737966
Phone
+98 71 4252 4840
Fax
Email
z.simin00@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Islamc Azadi university Arak.
Full name of responsible person
Mohsen Makhlough
Position
M.A
Latest degree
Master
Other areas of specialty/work
Street address
Amirkabir complex, 3km Khomin road, Arak, Markazi, Iran.
City
Arak
Province
Markazi
Postal code
3836119131
Phone
+98 912 553 6963
Fax
Email
PsychoRavan@yahoo.com
Web page address

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
because of full report of data analysis in the article
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
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