This study aimed at analyzing the effect of a spiritual intervention on the depression of the postmenopausal women who have referred to the Healthcare Centers in Isfahan City, Iran, in 2014.
Sixty four 45-60-year-old postmenopausal women whose score in Beck Depression Inventory are more than 13 and are willing to participate in this study will consist samples of this clinical trial. They will be excluded if they prefer to discontinue, then they will be divided randomly in two control and experimental intervention groups. spiritual intervention for 8 sessions will be organized for the intervention group in two centers of the Isfahan Health Care Centers. The Beck Depression Inventory (measuring tools of the main variables) will be completed through three phases of pretest, post test and follow-up (1 month) by participants of both groups.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015061422733N1
Registration date:2015-07-13, 1394/04/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-07-13, 1394/04/22
Registrant information
Name
Zohre Shafiee
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 26 3231 2022
Email address
zandiyeh@nm.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Isfahan University of Medical Sciences
Expected recruitment start date
2014-11-21, 1393/08/30
Expected recruitment end date
2014-12-31, 1393/10/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effect of spiritual intervention on depression in postmenopausal women
Public title
the effect of spiritual intervention on depression in postmenopausal women
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion Criteria: A score higher than 13 from the Beck Depression Inventory; ability to speak and understand the Persian language; believe in Islam; non-smoking; ability to read and write; 45 to 60-year-old; cessation of menstruation for a year; no history of hysterectomy and ovariectomy; free from communication problems; and avoiding participation in other spiritual courses.
Exclusion criteria: Reluctance of subjects to continue participating in the study; absence in more than one session in the training courses; experiencing psychological crises including death of close relatives; having aphasia; having any known psychological diseases except depression; taking antidepressant drugs; having a disease; hospitalized in a hospital; divorce.
Age
From 45 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
64
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 Isfahan University of Medical Sciences
Street address
Isfahan university of medical sciences, Shiraz gateway squar, Isfahan
City
Isfahan
Postal code
Approval date
2014-11-23, 1393/09/02
Ethics committee reference number
393632
Health conditions studied
1
Description of health condition studied
depression
ICD-10 code
F31.3
ICD-10 code description
mild or moderate depression
2
Description of health condition studied
-
ICD-10 code
-
ICD-10 code description
-
Primary outcomes
1
Description
depression
Timepoint
Pre-intervention, Immediately after intervention,One months after the intervention
Method of measurement
beck questionnaire depression
Secondary outcomes
empty
Intervention groups
1
Description
Intervention Group: With the agreement of members, a spiritual intervention including eight 60 to 90-minute sessions was held two days a week. The training courses of spirituality were held collectively for the test group members based on some spiritual interventions offered by Richards and Bergin with an Islamic approach and also on Quran verses and narratives of the Infallible Imams in terms of certain principles such as orison, self-consciousness, reliance on God and supplication. At the end of each course, participants were provided with a copy of the session’s discussions.
Category
Behavior
2
Description
For the control group, two training courses, different from the training courses of the test group, with the subject of nutrition and proper movement during the old age were held and they were provided with the training manual at the end of each session.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Navab health center
Full name of responsible person
zohre shafiee
Street address
Ahmadabad sq, Isfahan
City
Isfahan
2
Recruitment center
Name of recruitment center
Hazrat Ali health center
Full name of responsible person
zohre shafiee
Street address
Sheikh Toosi st,Isfahan
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Isfahan University of Medical Sciences
Full name of responsible person
Peyman Adibi doctor
Street address
Isfahan University of Medical Sciences, Shiraz Gateway Square, Isfahan
City
Isfahan
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 Isfahan 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
Isfahan University of Medical Sciences
Full name of responsible person
Zohre Shafiee
Position
Student master of science in nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Shiraz Gateway Square, Isfahan
City
Isfahan
Postal code
8174673461
Phone
+263 2312022
Fax
Email
zohre_shafiee65@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zohre Shafiee
Position
Student master of science in nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Shiraz Gateway Square, Isfahan
City
Isfahan
Postal code
Phone
+263 2312022
Fax
Email
zohre_shafiee65@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Zohre Shafiee
Position
Student master of science in nursing
Other areas of specialty/work
Street address
Isfahan University of Medical Sciences, Shiraz Gateway Square, Isfahan
City
Isfahan
Postal code
Phone
+263 2312022
Fax
Email
zohre_shafiee65@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)