Determining the effect of environmental activity on depressive symptoms
Design
•Randomized controlled trial with concurrent control and blinded outcome assessment. Computerized block randomization with concealed sequences. There are 40 members for each group and 80 as a whole. The participants enter the study after sample completion and will be followed up for one month after the end of the study.
Settings and conduct
Depression symptoms screening by 9-Item Patient health questionaire (PHQ9) and Beck Depression inventory II (BDI-II) among people who refer to Valfajr Clinic; Patients with mild to moderate depressive symptoms participating in the study after obtaining informed consent; Randomized allocation to intervention and control groups (each group contains 40 patient); Receiving educational worksheet by both groups and participating in environmental activity by intervention group that consists of planting and maintenance of plants in Almahdi Park., Azadi Squar.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
Aged 18 and above,Mild to moderate depression,Desire to participate in the study.
Exclusion criteria:
Severe depression,Any physical or mental diseases that could limit the environmental activity,Antidepressant drugs consumption, No desire to participate in the study.
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Intervention groups
Both intervention and control groups will receive educational worksheet as a treatment for depressive symptoms, but the intervention group will participate in environmental activity too.
The intervention lasts for 6 weeks.
We use Beck depression Inventory II (BDI-II) to assess the depression intensity and the effect of environmental activity on 0,3,6,10 weeks.
We also use 12-Item short form health survey (SF12) for both intervention and control groups to evaluate their quality of life.(the alternative aim of the study)
Main outcome variables
Depression severity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181206041871N1
Registration date:2019-10-12, 1398/07/20
Registration timing:registered_while_recruiting
Last update:2019-10-12, 1398/07/20
Update count:0
Registration date
2019-10-12, 1398/07/20
Registrant information
Name
France Minagar
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 26 3444 1082
Email address
minagar.f@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-09-23, 1398/07/01
Expected recruitment end date
2019-10-22, 1398/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Assessing the effect of environmental activity on depressive symptoms
Public title
Assessing the effect of environmental activity on depression
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate depression
aged 18 and above
The desire to participate in the study
Exclusion criteria:
severe depression
Antidepressant drugs consumption
Any physical or mental diseases that could limit the environmental activity.
No desire to participate in the study
Age
From 18 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
Block Randomization will be implemented using Microsoft Excel software. Quadriple blocks of random numbers with allocation to the groups are created. Based on that, the concealment sequences will be clarified. Only the creator of this file will know about it. Each random number will be written on an envelope in the same order that they have been created. Also, the name of the allocated group to that number (intervention or control) will be written on a piece of paper, and will be put in that envelope and sealed. All 4 envelopes are packed in one package and will be given to the person responsible for the delivery of them. In this way, 4 envelopes in a package will be given to 4 participants to choose from. Obviously, the person is unaware of the contents of the envelopes and the relevant groups. After delivering them to the participants and opening them, it will become clear which group the person will go to.
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 Iran University of Medical Sciences
Street address
Iran University of Medical Sciences, Next to Milad tower, Hemmat freeway, Tehran.
City
Tehran
Province
Tehran
Postal code
14496-14535
Approval date
2018-10-27, 1397/08/05
Ethics committee reference number
IR.IUMS.REC.1397.549
Health conditions studied
1
Description of health condition studied
Depression
ICD-10 code
F33.8
ICD-10 code description
Other recurrent depressive disorders
Primary outcomes
1
Description
Depression scores on Beck depression inventory II (BDI-II) scale
Timepoint
Assessing depression severity by Beck Depression Inventory (BDI-II) before intervention, 3 weeks after starting the intervention, at the end of intervention (6th week) and 1 month after the ending of the intervention.(0,3,6,10)
Method of measurement
Second version of 21- Item Beck Depression Inventory (BDI-II)
Secondary outcomes
1
Description
Quality of life score
Timepoint
Before the intervention, at the end of intervention (6th week) and 1 month after the ending of the intervention.(0,6,10)
Method of measurement
12-Item short form health survey for quality of life (SF12)
Intervention groups
1
Description
"The intervention group" will receive educational worksheet and also participate in environmental activity in a garden belonged to Flower and Herbal Clinic located in Almahdi Park in Azadi Square. The duration of environmental activity is twice weekly for one and a half hours for 6 weeks and consists of vegetable and flower growing. Educational worksheet includes behavioral activation, daily activity schedule, breathing training instruction,and relaxation instruction.They are then monitored at 0, 3, 6 and 10 weeks using the "Beck Depression Inventory" (BDI-II) and " 12-Item short form health survey for quality of life (SF12)" questionnaires.
Category
Treatment - Other
2
Description
Control group: The Control group will receive educational work sheet that consists of behavioral activation, daily activity schedule, breathing training instruction,and relaxation instruction.They are then monitored at 0, 3, 6 and 10 weeks using the "Beck Depression Inventory" (BDI-II) and "The 12-Item Short Form Health Survey (SF-12)" questionnaires.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Valfajr Clinic
Full name of responsible person
France Minagar
Street address
West Tehran Health Center, West Dastgheib Ave.,Ostad Moin BLV., Azadi St.
City
Tehran
Province
Tehran
Postal code
1349845951
Phone
+98 21 6602 3042
Fax
+98 21 6600 1931
Email
adminsite@iums.ac.ir
Web page address
http://whc.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Preventive Medicine and Public Health Center
Full name of responsible person
Dr. Marzieh Nojoomi
Street address
Preventive Medicine and Public Health Center,Iran University of Medical Sciences, Next to Milad tower, Hemmat Freeway.
City
Tehran
Province
Tehran
Postal code
14496-14535
Phone
+98 21 8670 3350
Email
pmph@iums.ac.ir
Web page address
http://pmph.iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Preventive Medicine and Public Health Center
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
Iran University of Medical Sciences
Full name of responsible person
France Minagar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No. 49, East 4th Ave., Gohardasht
City
Karaj
Province
Alborz
Postal code
3146987676
Phone
+98 26 3444 1082
Fax
Email
minagar.f@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
France Minagar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No. 49, East 4th Ave., Gohardasht
City
Karaj
Province
Alborz
Postal code
3146987676
Phone
+98 26 3444 1082
Fax
Email
minagar.f@tak.iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
France Minagar
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Family Physician
Street address
No. 49, East 4th Ave., Gohardasht
City
Karaj
Province
Alborz
Postal code
3146987676
Phone
+98 26 3444 1082
Fax
Email
minagar.f@tak.iums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
Data will not be available due to ethical issues. Only results will be published.
When the data will become available and for how long
Data will not be available due to ethical issues. Only results will be published.
To whom data/document is available
Data will be available only to researchers.The report will be submitted to the sponsor.The result will be published in an article in a journal that accepts it.
Under which criteria data/document could be used
Data is available only to researchers. Document is available at the discretion of the sponsor and the journal chief editor. (The journal which the article will be published in.)
From where data/document is obtainable
France Minagar, MD.
francemina@yahoo.com
What processes are involved for a request to access data/document
Data will not be available.
Comments
This study is conducted according to the rules of Iran University of Medical Sciences and Ethics Committee.