Protocol summary

Summary
The purpose of this study is to investigate the effect of educational intervention based on the theory of gerotranscendence on the transcendence, depression and life satisfaction of elderly people. Study population: 40 people (20 subjects and 20 controls) from the elderly covered by retirement centers of Rasht city. Inclusion criteria include: age 60 years and over, normal cognitive function measured by AMTS score, secondary education and higher, informed Consent to Participate in Research. Mild to moderate depression based on the GDS score and low life satisfaction based on the LSI-Z score. and exclusion criteria include: Drug use, missing more than one session of training sessions, Simultaneous participation in other psychotherapy programs and RCTs, Unwillingness to continue participating in research project for any reason. study Design: This study is a parallel Design RCT. Using block randomization method eligible samples are randomly assigned to experimental and control groups (subjects are not aware of their group assignment). Pre- test is done by completing questionnaires of gerotranscendence, depression and life satisfaction. The experimental group will participate in 6 training sessions (each session 1/5 hours). For the control group, only one training session will be held in the form of a group discussion about aging. The post- test is performed one week after the intervention and by completing the relevant questionnaires by both groups. Educational intervention is expected to reduce the rate of depression and increase the score of gerotranscendence and life satisfaction.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2017060534336N1
Registration date: 2017-08-05, 1396/05/14
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-08-05, 1396/05/14
Registrant information
Name
Shahla Asiri
Name of organization / entity
University of Social Welfare and Rehabilitation
Country
Iran (Islamic Republic of)
Phone
+98 13 4454 6860
Email address
sh.asiri@uswr.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, University of Social Welfare and Rehabilitation
Expected recruitment start date
2017-08-19, 1396/05/28
Expected recruitment end date
2017-09-19, 1396/06/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
efficacy of an educational intervention based on gerotranscendence theory on the transcendence, depression and life satisfaction of Iranian community dwelling elder people
Public title
efficacy of an educational intervention based on gerotranscendence theory on the transcendence, depression and life satisfaction of elder people
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria: age 60 years and over, normal cognitive function measured by AMTS score, secondary education and higher, informed Consent to Participate in Research. Mild to moderate depression based on the GDS score and low life satisfaction based on the LSI-Z score. exclusion criteria: Drug use, missing more than one session of training sessions, Simultaneous participation in other psychotherapy programs and RCTs, Unwillingness to continue participating in research project for any reason.
Age
From 60 years old to 139 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 University of Social Welfare and Rehabilitation
Street address
koodakyar street, Daneshjoo Boulvard, Evin
City
Tehran
Postal code
1985713834
Approval date
2016-10-05, 1395/07/14
Ethics committee reference number
IR.USWR.REC.1395.318

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
gerotranscendence
Timepoint
before and 1 week after intervention
Method of measurement
gerotanscendence scale (GTS-S)

2

Description
depression
Timepoint
before and 1 week after intervention
Method of measurement
geriatric depression scale (GDS)

3

Description
life satisfaction
Timepoint
before and 1 week after intervention
Method of measurement
life satisfaction index (LSI-Z)

Secondary outcomes

empty

Intervention groups

1

Description
The experimental group will participate in 6 training sessions based on gerotranscendence theory (each session 1/5 hours).
Category
Other

2

Description
For the control group, only one training session will be held in the form of a group discussion about aging.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rasht Retirement Centers
Full name of responsible person
Shahla Asiri
Street address
City
Bandar Anzali

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for Research, University of Social Welfare and Rehabilitation
Full name of responsible person
Hamid Reza Khanke
Street address
Koodakyar street, Daneshjoo Boulvard, Evin
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, University of Social Welfare and Rehabilitation
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
University of Social Welfare and Rehabilitation
Full name of responsible person
Shahla Asiri
Position
Phd Condidate in Gerontology
Other areas of specialty/work
Street address
Koodakyar street, Daneshjoo Boulvard, Evin.
City
Tehran
Postal code
1985713834
Phone
+98 21180004
Fax
Email
shahlaasiri@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Mahshid Foroughan
Position
Fellowship of Geriatric Psychiatry
Other areas of specialty/work
Street address
Koodakyar street, Daneshjoo Boulvard, Evin.
City
Tehran
Postal code
Phone
+98 21 2218 0004
Fax
Email
m_foroughan@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
University of Social Welfare and Rehabilitation
Full name of responsible person
Shahla Asiri
Position
Phd Condidate in Gerontology
Other areas of specialty/work
Street address
Koodakyar street, Daneshjoo Boulvard, Evin.
City
Tehran
Postal code
1985713834
Phone
+98 21 2218 0004
Fax
Email
shahlaasiri@yahoo.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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