The present study is searching new and inexpensive therapeutic method to enhance diabetic’s health by supposing the effectiveness of positive psychotherapy on mental well-being and glycemic reduction of patients with type 2 diabetes. In this clinical-trial study, 30 type 2 diabetic patients of Yazd Diabetes Research Center are selected randomly and put them in two groups of group positive psychotherapy and clinical control group. While participants of both groups continued their drug therapy, the intervention group received 7 sessions (90 minutes per week) group positive psychotherapy and control group received none. Data are gathered before intervention and two weeks after intervention. Data are gathered by Demographic Questionnaire, General Well-being Questionnaire (GWB) and glycemic test (HbA1c). SPSS-16 software, Kolmogorov-Smirnov Test, Chi-square and MANCOVA are used for analyzing data.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102916771N2
Registration date:2015-12-21, 1394/09/30
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-12-21, 1394/09/30
Registrant information
Name
Mohammad Hossein Sorbi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 35 3621 1306
Email address
mhosseinsorbi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Yazd Diabetes Research Center
Expected recruitment start date
2015-06-10, 1394/03/20
Expected recruitment end date
2016-02-09, 1394/11/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of positive psychotherapy on enhancing well-being and glycemic reduction of patients with type 2 diabetes
Public title
The effectiveness of positive psychotherapy on enhancing well-being and glycemic reduction of patients with type 2 diabetes: Clinical trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: stricken type 2 diabetes for at least 6 months; having the age of 30-55. Exclusion criteria: having a history of severe mental illness; concurrent treatment of other psychiatric illness.
Age
From 30 years old to 55 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
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Sadoughi University of Medical Sciences, Yazd
Street address
Bahonar street, Shahid Sadoughi University of Medical Sciences, Yazd
City
Yazd
Postal code
Approval date
2015-06-22, 1394/04/01
Ethics committee reference number
Ir.ssu.rec.1394.59
Health conditions studied
1
Description of health condition studied
Non-insulin-dependent diabetes mellitus
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Well-being & glycemic
Timepoint
Before and after the intervention
Method of measurement
Well-being questionnaire& HbA1c
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Optimism group psychotherapy is implemented during 7 sessions for 8 weeks and each one last 90minutes. The group consists of approximately ten persons and one manager. During the experimental period, subjects do the exercises in worksheets during each session.
Category
Behavior
2
Description
Control: No treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Yazd Diabetes Research Center
Full name of responsible person
Dr. Masoud Rahmanian
Street address
Yazd Diabetes Research Center, Bahonar street
City
Yazd
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Dr. Mohammad Reza Mirjalili
Street address
Yazd
City
Yazd
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Sadoghi 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 Univercity of Medical science
Full name of responsible person
Mohammad Hossein Sorbi
Position
Master of Science
Other areas of specialty/work
Street address
Seyed Gole Sorkh Street, Shah abolghasem, No 13
City
Yazd
Postal code
Phone
+98 35 3621 1306
Fax
Email
sorbih@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Sadoghi University of Medical Sciences
Full name of responsible person
Rahele Azizi
Position
MD
Other areas of specialty/work
Street address
Shahid Sadoghi University of Medical Sciences, Bahonar Street
City
Yazd
Postal code
Phone
+98 35 3724 2666
Fax
Email
reihane.azizi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Hossein Sorbi
Position
Mater of Science
Other areas of specialty/work
Street address
Seyed Gole Sorkh Street, Shahe abolghasem, No 13
City
Yazd
Postal code
Phone
+98 35 3621 1306
Fax
Email
sorbih@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)