The effect of family-centered empowerment program on depression, anxiety and stress among patients with obsessive-compulsive disorder and their caregiversʼ burden
To Determine The Effect of family-centered empowerment program on depression, anxiety and stress among patients with obsessive-compulsive disorder and their caregiversʼ burden.
Design
Semi-experimental research with pretest-post test design with control group in waiting list and one month follow-up of intervention and control group
Settings and conduct
After sampling and Assigning 25 patients in both Intervention and control groups ,Eight 60-minute training sessions and twice a week were held for the intervention group at Faculty of Nursing and Midwifery Nasibe(Sari).The content of the training sessions focused on increasing awareness of obsessive-compulsive disorder and familiarity with negative emotions and management.The training was conducted by a psychiatrist nurse as a lecture, question and answer, and a booklet.During this period, no intervention was performed for the control group.After one month of telephone follow up for the Intervention group, two groups again were evaluated.The questionnaires of this research included: Depression , Anxiety and Stress Scale , Maudsley Obsessive Compulsive Inventory, Zarit Caregiver Burden Questionnaire and General Health Questionnaire (GHQ-12).
Participants/Inclusion and exclusion criteria
Inclusion Criteria Included :Early diagnosis of Obsessive-Compulsive Disorder , At least 18 years of Age -The absence of psychosis and major depression and exclusion criteria included : having a physical illness (deaf, blind, motor disability) and mental retardation - Those who do not fully complete the questionnaire -those who do not attend the two-sessions of the training session
Intervention groups
25 Patient with Obsessive-Compulsive Disorder
Main outcome variables
depression - anxiety - stress - caregiver burden
General information
Reason for update
Acronym
بررسی تاثیر اجرای برنامه توانمندسازی خانواده محور برمیزان افسردگی ˛اضطراب واسترس بیماران وسواس جبری و بار مراقبتی مراقبین آنها
IRCT registration information
IRCT registration number:IRCT20171203037723N1
Registration date:2018-12-03, 1397/09/12
Registration timing:retrospective
Last update:2018-12-03, 1397/09/12
Update count:0
Registration date
2018-12-03, 1397/09/12
Registrant information
Name
Hamideh Azimi Lolaty
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 7343
Email address
azimihamideh@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-21, 1397/02/31
Expected recruitment end date
2018-07-22, 1397/04/31
Actual recruitment start date
2018-05-20, 1397/02/30
Actual recruitment end date
2018-08-20, 1397/05/29
Trial completion date
2018-10-22, 1397/07/30
Scientific title
The effect of family-centered empowerment program on depression, anxiety and stress among patients with obsessive-compulsive disorder and their caregiversʼ burden
Public title
The effect of family-centered empowerment program on depression, anxiety and stress among patients with obsessive-compulsive disorder and their caregiversʼ burden.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Initial diagnosis of OCD by a psychiatrist
The desire to participate in the study
Having at least 18 years of age
Spent at least six months from the time of diagnosis
Absence of psychotic disorders
Lack of major depression
Lack of physical illness (Deaf,blind, Disability Movement )and mental retardation
Exclusion criteria:
patients and their caregivers who do not attend two sessions of training sessions
Do not answer the questionnaire questions completely
Do not cooperate in carrying out assignments
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
25
More than 1 sample in each individual
Number of samples in each individual:
2
A person with a family member
Actual sample size reached:
50
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 Mazandaran University of Medical Sciences
Street address
central headquarters of Mazandaran University of Medical Sciences and Health Services , the beginning of Valiasr highway , Sari
City
sari
Province
Mazandaran
Postal code
48157-33971
Approval date
2018-04-29, 1397/02/09
Ethics committee reference number
IR. MAZUMS.REC.1397.1504
Health conditions studied
1
Description of health condition studied
Obsessive-compulsive disorder
ICD-10 code
F42
ICD-10 code description
Obsessive-compulsive disorder
Primary outcomes
1
Description
Depression score> = 14
Timepoint
Before Intervention - After Intervention - One Month After Intervention
Method of measurement
Depression,anxiety stress scale(DASS)
2
Description
- Caregiving Score> = 30
Timepoint
Before Intervention - After Intervention - One Month After Intervention
Method of measurement
Zarit caregivers burden
3
Description
Anxiety score> = 10
Timepoint
Before Intervention - After Intervention - One Month After Intervention
Method of measurement
Depression,anxiety stress scale(DASS)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group : Each patient will attend in Educational sessions with a family member.Eight Educational sessions will be held twice a week for one month.The sessions focused on obsessive-compulsive disorder and its treatment, the importance of family role and familiarity with negative emotions and their management.The lecture and question and answer method and the slideshow will be used.
Category
Other
2
Description
Control group: Each patient will be accompanied by a family member in the research.The control group will receive routine center care and Will not attend in Educational sessions .The control group will complete only the questionnaires.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Baghban Specialist Clinic(Tuba)
Full name of responsible person
Hamideh Azimi Lolaty
Street address
Sari City , Khazar Boulevard
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3324 0002
Email
azimihamideh@gmail.com
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi Lolaty
Street address
Amir Mazandarani Blvd. Vesal Shirazi Ave.-Nasibe Nursing and Midwifery Faculty
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3367 7343
Fax
+98 11 3336 2569
Email
azimihamideh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari 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
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi Lolaty
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandaran Boulevard, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3367 7343
Email
azimihamideh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi lolaty
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandaran Boulevard, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3367 7343
Email
azimihamideh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hamideh Azimi lolaty
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Amir Mazandaran Boulevard, Vesal Shirazi Avenue
City
Sari
Province
Mazandaran
Postal code
48157-33971
Phone
+98 11 3367 7343
Email
azimihamideh@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not 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
......
When the data will become available and for how long
..............
To whom data/document is available
.............
Under which criteria data/document could be used
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From where data/document is obtainable
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What processes are involved for a request to access data/document