Effect of group logo therapy on depression and anxiety in patients with cancer: A clinical trial study
Design
Open-label, parallel group, randomized trial.
Thirty patients will be randomly assigned to experimental and control group.
Settings and conduct
After studying and signing consent form, participants are randomly replaced in groups. Subsequently, the test group members will undergo a group logo therapy training, after a full explanation of their research and satisfaction from them for 10 weeks, weekly in one session and about 60 to 70 minutes. All subjects will complete all research tools in two rounds. Upon completion of the ten sessions of group logo therapy, again, both the test (test and control) will be tested by research tools. The site of the project is in the Shahid Ghazi Tabatabaaei hospital of Tabriz city .
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a 20 to 45 year old age range, having reading and writing skills, satisfaction to participate in research
Exclusion criteria: having a comorbid physical illness, having a psychiatric disorder
Intervention groups
Experimental group will have group logo therapy and control group don't have any interventions.
Main outcome variables
Depression, Anxiety
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171203037729N2
Registration date:2018-06-25, 1397/04/04
Registration timing:registered_while_recruiting
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Rasoul Heshmati
Name of organization / entity
University of Tabriz
Country
Iran (Islamic Republic of)
Phone
+98 41 3475 7626
Email address
psy.heshmati@tabrizu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-06-05, 1397/03/15
Expected recruitment end date
2018-08-06, 1397/05/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of group logo therapy on depression and anxiety in patients with cancer: A clinical trial study
Public title
group logo therapy
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having a 20 to 45 year old age range
Having reading and writing skills
Satisfaction to participate in research
Exclusion criteria:
Having a comorbid physical illness
Having a psychiatric disorder
Age
From 20 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
simple randomization
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 Tabriz University
Street address
Central Building No. 2, Third Floor, Research & Technology Dept. Golghast St, Tabriz University of Medical Sciences.Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Approval date
2018-05-25, 1397/03/04
Ethics committee reference number
IR.TBZMED.REC.1396.719
Health conditions studied
1
Description of health condition studied
cancer
ICD-10 code
c80.9
ICD-10 code description
Malignant neoplasm, primary site unspecified
Primary outcomes
1
Description
depression
Timepoint
assessing of depression at the beginning of the study and 10 weeks after intervention
Method of measurement
Beck Depression Inventory
2
Description
anxiety
Timepoint
assessing of anxiety at the beginning of the study and 10 weeks after intervention
Method of measurement
Beck Anxiety Inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Group lpgo therapy
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Ghazi Tabatabaaei hospital of Tabriz city
Full name of responsible person
Rasoul Heshmati
Street address
university street, golgasht street, Shahid Ghazi Tabatabaaei hospital of Tabriz city
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3334 4280
Email
psy.heshmati@tabrizu.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Tabriz
Full name of responsible person
Rasoul Heshmati
Street address
29Bahman street, university of tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3475 7626
Email
psy.heshmati@tabrizu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The 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
University of Tabriz
Full name of responsible person
Rasoul Heshmati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Faculty of psychology, Tabriz university, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Email
psy.heshmati@tabrizu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Rasoul Heshmati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Tabriz university . faculty of psychology
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Email
psy.heshmati@tabrizu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Tabriz
Full name of responsible person
Rasoul Heshmati
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
psychology
Street address
Faculty of psychology, Tabriz university, Tabriz.
City
Tabriz
Province
East Azarbaijan
Postal code
5175698425
Phone
+98 41 3475 7626
Email
psy.heshmati@tabrizu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data is publishable after being unidentifiable
When the data will become available and for how long
6 month after result publition
To whom data/document is available
for all researchers
Under which criteria data/document could be used
Only for the purpose of using data and protocols in other research work
From where data/document is obtainable
abriz-University of Tabriz-Department of Psychology-Mr. Rasoul Heshmati-09198260681 Email: psy.heshmai@gmail.com
What processes are involved for a request to access data/document
Requesting from researcher and sending it by post or e-mail