Protocol summary

Summary
This study is an interventional study. The goal of study is determining the effect of emotion regulation training on the stress, anxiety, depression and resiliency caregiver’s family of patients with schizophrenia. Inclusion criteria are, Both sexes, Patients who were hospitalized more than once, mental health of caregiver, Direct communication with the patient , and exclusion criteria are, caregivers less than 15 years old; Absence of more than 2 sessions in the curriculum. The population of the study is the caregiver’s family of patients with schizophrenia that refer to Psychiatric Hospital Shahid Beheshti, affiliated to Kerman University of Medical Sciences. The sample size is, 70 caregiver, and randomly are divided, one experimental group and one control group (each group of 35 people). The intervention is caregiver’s education. The duration of the study is 6 months(onset:2017-09-06). Before the training, DASS21 and Resiliency questionnaires is given two groups. Then experimental group is placed under training for 8 sessions of 60 minutes, and the control group does not receive any training. After the training sessions, the questionnaires are complete by two groups. The outcome of this research is the effect of training on the degree of stress, anxiety, depression and resiliency in caregivers.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017061733997N2
Registration date: 2017-08-16, 1396/05/25
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-16, 1396/05/25
Registrant information
Name
Tahereh Ramezani
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34331325220
Email address
t_ramezani@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology kerman university of medical science
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-03-06, 1396/12/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of emotion regulation training on stress, anxiety , depression and resiliency among caregivers family of patients with schizophrenia.
Public title
The effects of emotion regulation training on stress, anxiety , depression and resiliency among caregivers family of patients with schizophrenia .
Purpose
Health service research
Inclusion/Exclusion criteria
Inclusion criteria : Both sexes; Patients who were hospitalized more than once; mental health of caregiver; Direct communication with the patient; and exclusion criteria: caregivers less than 15 years old; Absence of more than 2 sessions in the curriculum.
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 70
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
The participants, are assigned randomly block, into two groups of control and intervention (each group of 35 samples).

Secondary Ids

1

Registry name
no
Secondary trial Id
no
Registration date
empty

Ethics committees

1

Ethics committee
Name of ethics committee
Vice Chancellor for Research and Technology,Ethics committee of kerman University of Medical Science
Street address
-Deputy of Research and Technologyof Kerman University of Medical Sciences-Vice Chancellor for Research, Street Ibn Sina, Tahmasebabad Crossroads-
City
Kerman
Postal code
۷۶۱۸۷۴۷۶۵۳
Approval date
2010-06-10, 1389/03/20
Ethics committee reference number
الف: 375/60/10/96

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

2

Description of health condition studied
Stress
ICD-10 code
F43.0
ICD-10 code description
Acute stress reaction

3

Description of health condition studied
Depression
ICD-10 code
F31.9
ICD-10 code description
Bipolar affective disorder, unspecified

4

Description of health condition studied
Resiliency
ICD-10 code
F99-F99
ICD-10 code description
Unspecified mental disorder

Primary outcomes

1

Description
depression,anxiety,stress,resiliency
Timepoint
before and after education
Method of measurement
questionner

Secondary outcomes

1

Description
depression,anxiety,stress,resiliency
Timepoint
before and after education
Method of measurement
questionnaire

Intervention groups

1

Description
The experimental group will complete the questionnaires before the curriculum, and they will place under the emotion regulation training for 8 sessions of 60 minutes. The relevant training is done by the psychologist. Teaching is delivered as a lecture, a question and answer, as well as a training booklet. Session 1: Communicating and Conceptualizing and the need to use of regulation excitement training, Session 2: awareness of positive threats and types, Session 2: awareness of negative threats and types, Session 4: accepting positive excitement, Session5: accepting negative excitement, Session 6: re-evaluating and expressing positive emotions, Session 7: re-evaluating and expressing negative emotions, Session 8: Summing up the training sessions and asking questions and completing the questionnaires.
Category
Treatment - Drugs

2

Description
The control group will complete the questionnaires before the curriculum, but they do not receive any training, and after completing education course, they will complete the questionnaires again.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahide Beheshti Psychiatric Hospital in Kerman
Full name of responsible person
Street address
Shahide Beheshti Psychiatric Hospital, Gomhoori Boulevard-
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research and Technology, kerman University of Medical Science-
Full name of responsible person
Abbas Pardakhty
Street address
Vice Chancellor for Research and Technology of Kerman University of Medical Sciences , Street Ibn Sina,Tahmasebabad Crossroads.
City
kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research and Technology, kerman University of Medical Science-
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
kerman University of Medical Science
Full name of responsible person
Tahereh Ramezani
Position
master degree,faculty
Other areas of specialty/work
Street address
Kerman University of Medical Sciences Campus, beginning around Seven Alavi Garden,
City
kerman
Postal code
1355376169
Phone
+98 34 3132 5700
Fax
Email
t_ramezani2kmu.ac.ir
Web page address
kmu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Tahereh Ramezani
Position
master degree,faculty
Other areas of specialty/work
Street address
Kerman University of Medical Sciences Campus , beginning around Seven Alavi Garden, Kerman.
City
Kerman
Postal code
Phone
+98 34 3132 5220
Fax
Email
t_ramezani@ kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman University of Medical Science
Full name of responsible person
Tahereh Ramezani
Position
master degree,faculty
Other areas of specialty/work
Street address
Kerman University of Medical Sciences Campus , beginning around Seven Alavi Garden, Kerman.
City
Kerman
Postal code
13555-76169
Phone
+98 34 3132 5220
Fax
Email
t_ramezani@kmu.ac.ir
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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