Protocol summary

Summary
This study aims to assess the effects of coping strategies on the burden of care and quality of life of family caregivers of people with chronic mental disorders. Type non-randomized clinical trial is a test group and control. Is available sampling and control tests will be two groups of people. A sample of 47 people. The questionnaire put two hands. The intervention of 8 sessions for 2 months and each session will be held for 90 minutes in the test group. After the intervention groups and 2 months after completion of the questionnaire will be completed in the control group will run the same routine. Inclusion criteria: (a) careful: age range 60-18 years, literacy, health, sight and hearing, did not receive previous training on coping strategies, mental illness and chronic physical well-known lack of care, non-disorder drug abuse or drug dependence, lack of crisis situations in the past six months in care, no responsibility for the emotional and physical care of a sick patient (b): at least 1 year of diagnosis. exclusion criteria: no the desire to continue to receive training and participate in the research, participate in the second session of the eighth meeting of the classes, participate in similar training sessions in parallel.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015120925450N1
Registration date: 2016-11-26, 1395/09/06
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-11-26, 1395/09/06
Registrant information
Name
Fahimeh Ramezani
Name of organization / entity
Iran University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8888 2885
Email address
inanlo.m@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Iran University of Medical Sciences
Expected recruitment start date
2016-01-21, 1394/11/01
Expected recruitment end date
2016-05-21, 1395/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of coping strategies training on the burden and quality of life among the family caregivers of People with chronic mental disorders
Public title
Coping strategy training to family caregivers of people with chronic mental disorders
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: a - watch out: aged 60 -18 years, literacy, health, sight and hearing, did not receive previous training on coping strategies, mental illness and chronic physical well-known lack of care, non-disorder drug abuse or drug dependence, lack of crisis situation in care in the last six months (severe stress, death of close family members), lack of responsibility for the emotional and physical care of a sick patient (b): passed at least 1 year of diagnosis; exclusion criteria from the study: lack of desire to continue to receive training and participate in the research, participate in the second session of the eighth meeting of the classes, participate in similar training sessions in parallel
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: 94
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee Of Iran University Of Medical Sciences
Street address
Ethics Committee, Iran University of Medical Sciences, Sheikh Shahid Chamran highway lighting, the grace of Allah, Hemmat, Tehran
City
Tehran
Postal code
Approval date
2015-10-13, 1394/07/21
Ethics committee reference number
IR.IUMS.REC.1394.9211196214

Health conditions studied

1

Description of health condition studied
chronic mental disorders(schizophrenia,bipolar)
ICD-10 code
V
ICD-10 code description
F20,F31

Primary outcomes

1

Description
Burden
Timepoint
Before and two months after intervention
Method of measurement
Zarit burden interview

Secondary outcomes

1

Description
Quality of life
Timepoint
Before and two months after intervention
Method of measurement
Quality of Life Questionnaire sf36

Intervention groups

1

Description
Intervention group: A non-randomized clinical trial is a test group and control. And for caregivers in the intervention group teaching coping strategies consists of 8 training sessions with given objectives will be for 2 months, during 8 consecutive weeks (week 1 time) and each session lasts 90 minutes in groups and each group consisted of 10 people the groups will be held. The first meeting of coping strategies training program content: Introduction, Introduction and referrals, training program outlines and goals, second session: Introduction to Mental Disorders (definition, etiology, signs and symptoms), the third session: conceptualization and description of stress, symptoms and its consequences on life, sources of stress, the fourth session: the importance of learning coping strategies, problem-focused coping strategies are familiar with the types of emotion-driven and ineffective, the fifth session: effective methods of coping include stress management, time management, decision skills making, management, lifestyle (sleep, rest and exercise), sixth session: Introduction to other ways to reduce caregiver's anxiety such as relaxation techniques, deep breathing seventh session: verbal and non-verbal communication, body language, how to communicate with the patient and conflict resolution related to the effective use of resources, support, eighth session: Analysis and review past sessions, will be
Category
Lifestyle

2

Description
Control group: control group will not be any intervention pamphlet prepared for the control group and in the end they will be delivered.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
Hospitals martyr Yahya Nejad and Ayatollah Rouhani
Full name of responsible person
Mehrnoosh Inanloo
Street address
School of Nursing and Midwifery, Shahid Yasemi street, Valiasr, Tehran
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Seyed ali gavad musavi
Street address
Headquarters, Iran University of Medical Sciences, Sheikh Shahid Chamran highway lighting, the grace of Allah, Hemmat, Tehran
City
Tehran
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 of Iran University of Medical Sciences
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
Iran University of Medical Sciences,School of Nursing and Midwifery
Full name of responsible person
Mehrnoosh Inanloo
Position
Master of Science in Nursing/ teacher
Other areas of specialty/work
Street address
Valiasr, Shahid Yassami, School of Nursing and Midwifery, Iran
City
Tehran
Postal code
1997613883
Phone
+98 21 8888 2885
Fax
Email
inanloo.mehr@gmail.com/inanlo.m@iums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University of Medical Sciences,School of Nursing and Midwifery
Full name of responsible person
Mehrnoosh Inanloo
Position
teacher
Other areas of specialty/work
Street address
Valiasr,Shahid Yassami, School of Nursing and Midwifery, Iran
City
Thran
Postal code
1997613883
Phone
+98 21 8888 2885
Fax
+98 912 623 4269
Email
inanloo.mehr@gmail.com inanlo.m@iums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University of Medical Sciences,School of Nursing and Midwifery
Full name of responsible person
Fahimeh Ramezani
Position
Mental Health Nursing graduate student
Other areas of specialty/work
Street address
School of Nursing and Midwifery, Shahid Yasemi street, Valiasr, Tehran
City
Tehran
Postal code
Phone
+98 21 8888 2885
Fax
+98 21 8879 3805
Email
ramezanif7@gmail.com
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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