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IRCT20181206041871N1 IRCT 2019-10-12 Preventive Medicine and Public Health Center Assessing the effect of environmental activity on depression Assessing the effect of environmental activity on depressive symptoms 2019-09-23 anticipated 40 Complete https://irct.ir/trial/36509 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Depression. Intervention 1: "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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is "There is no further information."
public France Minagar
No. 49, East 4th Ave., Gohardasht
Karaj Iran (Islamic Republic of) 3146987676 +98 26 3444 1082 minagar.f@tak.iums.ac.ir Iran University of Medical Sciences scientific France Minagar
No. 49, East 4th Ave., Gohardasht
Karaj Iran (Islamic Republic of) 3146987676 +98 26 3444 1082 minagar.f@tak.iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Mild to moderate depression aged 18 and above The desire to participate in the study 18 years no limit Both severe depression Antidepressant drugs consumption Any physical or mental diseases that could limit the environmental activity. No desire to participate in the study F33.8 Other recurrent depressive disorders Treatment - Other Treatment - Other "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. 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. 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). 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). Preventive Medicine and Public Health Center Approved 2018-10-27 Ethics committee of Iran University of Medical Sciences Iran University of Medical Sciences, Next to Milad tower, Hemmat freeway, Tehran. Tehran Tehran Iran (Islamic Republic of)