Protocol summary

Study aim
Determining the effectiveness of Oriental Mind Philosophy (Tai Chi Chuan) on improving depressive symptoms, sleep quality, and mental health in subclinical depressed people
Design
The research method was quasi-experimental with a pretest-posttest design with a control group. The statistical population of this study was men with depressive symptoms, and by available sampling method and using screening and observance of entry and exit criteria based on individuals selected by gender matching method, in two groups of 15 people (15 people in the experimental group, 15 control group) were replaced. Then these two groups were assigned to the experimental group and the control group based on random allocation.
Settings and conduct
The study site was Takhti Sports Hall in Sardasht, Iran. The study group performed two sessions of exercise for forty-five minutes each week for five months.
Participants/Inclusion and exclusion criteria
Inclusion criteria: gaining a score between 19 and 29 in the Beck Depression Inventory; age range between 25 to 35 years old; conscious desire and satisfaction to participate in the research project. Exclusion criteria: suffering from one of the most severe physical illnesses; severe neurological disorders or the presence of psychotic symptoms; unwillingness to continue education; the presence of suicidal idea and the risk of suicide.
Intervention groups
Chen-style tai chi exercise was performed for five months and two forty-five minute sessions each week. During this time, no exercise program was performed on the control group.
Main outcome variables
Symptoms of depression; sleep quality and mental health

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201102049230N1
Registration date: 2020-11-23, 1399/09/03
Registration timing: retrospective

Last update: 2020-11-23, 1399/09/03
Update count: 0
Registration date
2020-11-23, 1399/09/03
Registrant information
Name
Somayeh Morsaljahan
Name of organization / entity
The University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 44 4462 9164
Email address
somayeh.morsal1994@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-06-22, 1398/04/01
Actual recruitment start date
2019-01-21, 1397/11/01
Actual recruitment end date
2019-06-22, 1398/04/01
Trial completion date
2019-06-22, 1398/04/01
Scientific title
The Effectiveness of Oriental Mind Philosophy (Tai Chi Chuan) on Improving Symptoms of Depression, Sleep Quality, and Mental Health in Depressed Subjects
Public title
The effect of Tai Chi on depression, quality of sleep, and mental health
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Achieving a score between 19 and 29 in the Beck Depression Inventory Conscious desire and satisfaction to participate in the research project Age range between 25 and 35 years old
Exclusion criteria:
Having one of the most physical severe illnesses. Severe neurological disorders or the presence of psychotic symptoms. Reluctance to continue training. Existence of suicidal ideation and possible risk of suicide.
Age
From 25 years old to 35 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Block randomization was individual, layered, and statistical software. A sample of 30 depressed patients was randomly assigned to the web https://www.randomization.com/, 15 dual AB blocks were appointed by the supervisor in two groups of 15 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
Data analysis was performed by data analyzer. He did not know the nature of AB groups. All data was provided to him in encrypted form.
Placebo
Not used
Assignment
Parallel
Other design features
This clinical trial consisted of two groups: intervention and control, single blind and randomized.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Science
Street address
Central Building No. 2, Third Floor, Deputy of Research and Technology, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2019-06-03, 1398/03/13
Ethics committee reference number
IR.TBZMED.REC.1398.288

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.9
ICD-10 code description
Major depressive disorder, single episode, unspecified

Primary outcomes

1

Description
Depression
Timepoint
Before intervention and 36 sessions after intervention
Method of measurement
Beck Depression Inventory-II(BDI-II)

2

Description
Sleep Quality
Timepoint
Before intervention and 36 sessions after the intervention
Method of measurement
Pittsburgh Sleep Quality Index (PSQI)

Secondary outcomes

1

Description
Mental Health
Timepoint
Before intervention and 36 sessions after intervention
Method of measurement
Goldberg General Health Questionnaire (GHQ-28)

Intervention groups

1

Description
Intervention group: Do Tai Chi Chuan Chen style exercise, 5 months, 2 times a week, 45 minutes each time
Category
N/A

2

Description
Control group: No action
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Takhti Club
Full name of responsible person
Loghman Rostami
Street address
Sarcheshmeh square, Sardasht city
City
Sardasht
Province
West Azarbaijan
Postal code
5771753837
Phone
+98 44 4462 9164
Fax
Email
Somayeh.morsal1994@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research and Technology, University of Tabriz
Full name of responsible person
Mahmoud Reza Sharghi
Street address
29 Bahman Boulevard, Tabriz, East Azerbaijan Province
City
Tabtiz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3339 3630
Fax
+98 41 3334 4273
Email
mr.sharghi@tabrizu.ac .ir
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 and Technology, University of Tabriz
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
The University of Tabriz
Full name of responsible person
Somayeh Morsaljahan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
29 Bahman Blvd.,Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Fax
Email
Somayeh.morsal1994@gmail.com
Web page address
http://www.tabrizu.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Somayeh Morsaljahan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
29 Bahman Blvd.,Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Fax
Email
Somayeh.morsal1994@gmail.com
Web page address
http://www.tabrizu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Somayeh Morsaljahan
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
29 Bahman Blvd.,Tabriz, East Azarbaijan
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 0081
Fax
Email
Somayeh.morsal1994@gmail.com
Web page address
http://www.tabrizu.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
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Loading...