Protocol summary

Summary
This study is a structural equation modeling; the study sample includes 37 clinically depressed students of Kermanshah University of Medical Science in the academic year 2013-2014. Subsequent to the structured interview, participants sign a statement of informed consent informing them of their freedom to withdraw at any time. Inclusion criteria: Depression score in the BDI-II between 14 and 28 and diagnosed depressive disorder based on the Diagnostic Interview Exclusion criteria: 1. Other disorders in the axis 1. 2. Suicidal thought or severe depression. 3. At the same time, receiving psychiatric treatment or psychotherapy. Participants were randomly allocated to two groups (by Drawing), an experimental and a control group. Before engaging in therapy, we assesses depression (BDI), negative automatic thoughts (ATQ), dysfunctional attitudes (DAS), and early maladaptive schema scores, and then the experimental groups receive eight sessions of aerobic exercise (three times a week), and the control group receive no treatment. At the end of the treatment, once again we assess experimental and control groups. The general objective of this study is to determine the effectiveness of group aerobic exercise on depressed students' cognitive change process. Specific objectives include: 1. Determining the effectiveness of group aerobic exercise on depression. 2. Determining the effectiveness of group aerobic exercise on the negative automatic thoughts. 3. Determining the effectiveness of group aerobic exercise on dysfunctional assumptions. 4. Cognitive models for the effect of aerobic exercise on depression.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015093024282N1
Registration date: 2015-11-26, 1394/09/05
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-11-26, 1394/09/05
Registrant information
Name
Arash Parsa Moghadam
Name of organization / entity
Kermanshah University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 0177
Email address
a.parsa@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Research proposal of Kermanshah University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-12-21, 1395/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group aerobic exercise on depressed students' cognitive change process comparing with cases without intervention
Public title
The effectiveness of group aerobic exercise on depressed students' cognitive change process
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Depression score in the BDI-II between 14 and 28 and diagnosed depressive disorder based on the Diagnostic Interview. Exclusion criteria: 1. Other disorders in the axis 1. 2. Suicidal thought or severe depression. 3. At the same time, receiving psychiatric treatment or psychotherapy.
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 37
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 Kermanshah University of Medical Sciences
Street address
Shahid Beheshti "Blvd.", Building "No."2, Kermanshah University of Medical Sciences.
City
kermanshah
Postal code
6714673159
Approval date
2015-10-20, 1394/07/28
Ethics committee reference number
KUMS.REC.1394.130

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32.1, F32
ICD-10 code description
Mild depressive episode: Two or three of the above symptoms are usually present. The patient is usually distressed by these, but will probably be able to continue with most activities. Moderate depressive episode: Four or more of the above symptoms are us

Primary outcomes

1

Description
Cognitive change process in depressed students
Timepoint
Before and after intervention
Method of measurement
Dysfunctional attitudes questionnaire, and automatic thoughts questionnaire

2

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

3

Description
Early maladaptive schema
Timepoint
Before and after intervention
Method of measurement
Early maladaptive schema questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
1. The experimental groups receive eight sessions of aerobic exercise (three times a week) Each exercise session consisted of the following: Before starting, carotid or wrist pulse is measure and record. Exercise starts with warm-up exercises, stretching, and primary breathing. The movements of the head and neck or legs start normally, this phase lasted 10 minutes; and then the movements are conducts with moderate intensity (60% - 80% heart rate). This step is along with faster movements of hands and feet separately and one-sided, bilateral and cross the legs movements. At this stage, the carotid or wrist pulse is measure and record which lasts 30-35 minutes. The last phase is cool down; the movement is done with less intensity which lasted about 10-15 minutes.
Category
Behavior

2

Description
2. The control group receive no treatment
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of physical education
Full name of responsible person
Ahmad Mazahri
Street address
Department of physical education, Shahid Beheshti, Kermanshah
City
kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research, Kermanshah University of Medical Sciences
Full name of responsible person
Behroz Hamzei
Street address
Research and technology deputy, Shahid Beheshti "Blvd.", Kermanshah
City
kermanshah
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, Kermanshah 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
Kermanshah University Of Medical Science
Full name of responsible person
Aliakbar Parvizifard
Position
Assistant professor
Other areas of specialty/work
Street address
Dep. of clinical psychology, school of medicine, Shahid Shiroudi "Blvd."
City
kermanshah
Postal code
Phone
+98 918 330 8692
Fax
Email
aliakbar.parvizifard@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Khirollah Sadeghi
Position
ph.d of clinical psychology
Other areas of specialty/work
Street address
Dep. of clinical psychology, school of medicine, Shahid Shiroudi
City
kermanshah
Postal code
Phone
+98 912 210 3544
Fax
Email
kh.sadeghi@kums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Aliakbar Parvizifard
Position
Assistant professor
Other areas of specialty/work
Street address
Dep. of clinical psychology, school of medicine, Shahid Shiroudi "Blvd."
City
kermanshah
Postal code
Phone
+98 918 330 8692
Fax
Email
aliakbar.parvizifard@gmail.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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