This study aims to investigate the effect of peer-group support on subjective well-being and family adaptation of spouses of men diagnosed with post-traumatic stress disorder. The sample includes a total of 80 spouses of men diagnosed with post-traumatic stress disorder referring to a special psychiatric clinic affiliated to Birjand University of Medical Sciences. In this one site study, there will be no blinding, and the participants will be selected using convenience sampling and regarding inclusion criteria. At first, demographic characteristics form, Subjective Well-being Questionnaire, and Family Adaptation Scale will be completed by all selected subjects. In the next step, the participants will be randomly assigned into control (n=40) and intervention groups (n=40) using blocking. For the intervention group, weekly peer-group support sessions will be held for 6 weeks. The control group will not receive any intervention. At the end as well as one month after intervention, both groups will complete the Subjective Well-being Questionnaire and Family Adaptation Scale.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016083117756N5
Registration date:2016-09-30, 1395/07/09
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-09-30, 1395/07/09
Registrant information
Name
Mohammad Bagher Roozgar
Name of organization / entity
Birjand University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 56 3239 5680
Email address
mbroozgar@bums.ac.ir
Recruitment status
Recruitment complete
Funding source
Birjand University of Medical Sciences
Expected recruitment start date
2016-10-31, 1395/08/10
Expected recruitment end date
2016-11-30, 1395/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of peer-group support on subjective well-being and family adaptation of spouses of men diagnosed with post-traumatic stress disorder
Public title
Effect of peer-group support on subjective well-being and family adaptation
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: 1. Confirmed diagnosis of post-traumatic stress disorder in spouses of potential participants by a psychiatrist, based on Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria; 2. Lack of history of psychiatric illness or drug abuse among potential participants; 3. Informed consent for participation in the study; 4. Residence in Birjand or the possibility of attending in the sessions designed in the study; 5. Having at least reading and writing ability; and 6. At least two years history of PTSD in spouses of potential participants. Exclusion criteria: Failure to attend in more than two sessions of the designed sessions in the study.
Age
From 18 years old to 70 years old
Gender
Female
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
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
Ethics committee of Birjand University of Medical Sceinces
Street address
Birjand University of Medical Sceinces, Ghaffari St.,
City
Birjand,
Postal code
Approval date
2016-04-27, 1395/02/08
Ethics committee reference number
Ir.bums.1395.5
Health conditions studied
1
Description of health condition studied
Post-traumatic stress disorder
ICD-10 code
ّ43.1
ICD-10 code description
Post-traumatic stress disorder
Primary outcomes
1
Description
Family adaptation
Timepoint
Before, immediately after, and 30 days after intervention
Method of measurement
Family Adaptation Questionnaire
2
Description
Subjective Well-being
Timepoint
Before, immediately after, and 30 days after intervention
Method of measurement
Subjective Well-being Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: Weekly peer-group support sessions will be held for them for 6 weeks.
Category
Other
2
Description
Control Group: This group will not have any interventions.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Specialized psychiatric clinic affiliated to Birjand University of Medical Science
Full name of responsible person
Seyyed Abolfazl Vagharseyyedin
Street address
Birjand University of Medical Sciences, Ghaffari St.
City
Birjand
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Birjand University of Medical Sciences
Full name of responsible person
Dr Tooba Kazemi
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
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 Birjand 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
Birjand University of Medical Sciences
Full name of responsible person
Dr Seyyed Abolfazl Vagharseyyedin
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
9717853577
Phone
+98 56 3241 2186
Fax
Email
waghars@bums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Dr Seyyed Abolfazl Vagharseyyedin
Position
Assistant Professor
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
Phone
+98 56 3241 2186
Fax
Email
waghars@bums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Birjand University of Medical Sciences
Full name of responsible person
Mohammad Bagher Roozgar
Position
PhD Candidate of Translation
Other areas of specialty/work
Street address
Birjand University of Medical Sciences, Ghaffari St.,
City
Birjand,
Postal code
9717853577
Phone
00
Fax
Email
Mbroozegar@bums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)