The effect of group cognitive- behavioral therapy with aerobic exercise in General Health, Mental Well-Being and Life Expectancy in People with Type 2 Diabetes
The aim of current study is the comparison of the efficiency of group cognitive- behavioral therapy with aerobic exercise in General Health, Mental Well-Being and Life Expectancy in People with Type 2 Diabetes. This study is a pretest- posttest study with control group. The research community is all patients referred to Kermanshah diabetes centers. The sample consisted of 36 patients with diabetes who have low scores on the General Health Questionnaire and The sample consisted of 36 patients with diabetes who have low scores on the General Health Questionnaire.
Inclusion criteria are:
Having type 2 diabetes
Having at least a high school diploma
Age above 35 years and below 60 years
Non-use of psychiatric medications or other treatment before or during the intervention
Exclusion criteria include:
The presence of significant psychiatric disorder
Any impairment and physical disability
There are other current or past abuses or drug dependence
Thoughts of suicide
After sampling the subjects are randomly divided into three groups: cognitive behavior therapy, aerobic exercise and control groups. Data are collected at baseline and after interventions (after 8 week). The primary outcome measure include: General Health, Mental Well-Being and Life Expectancy and HbA1C.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012610063N5
Registration date:2015-02-07, 1393/11/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-02-07, 1393/11/18
Registrant information
Name
Kheirollah Sadeghi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 0700
Email address
khsadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Kermanshah University of Medical Sciences
Expected recruitment start date
2014-06-01, 1393/03/11
Expected recruitment end date
2014-09-01, 1393/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of group cognitive- behavioral therapy with aerobic exercise in General Health, Mental Well-Being and Life Expectancy in People with Type 2 Diabetes
Public title
The effect of group cognitive- behavioral therapy with aerobic exercise in General Health, Mental Well-Being and Life Expectancy in People with Type 2 Diabetes
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are:
1. Having a higher score of 22 on the general health questionnaire
2. Having type 2 diabetes
3. Having at least a high school diploma
4. Age above 35 years and below 60 years
5. Non-use of psychiatric medications or other treatment before or during the intervention
Exclusion criteria include:
1. The presence of significant psychiatric disorder
2. Any impairment and physical disability
3. There are other current or past abuses or drug dependence
4. Thoughts of suicide
Age
From 35 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Kermanshah University of Medical Science
Street address
Vice – Chancellery of Research & Technology Affairs, building No.2,shahid beheshti blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2014-05-19, 1393/02/29
Ethics committee reference number
4676
Health conditions studied
1
Description of health condition studied
Type II of diabets
ICD-10 code
E11
ICD-10 code description
Non-insulin-dependent diabetes mellitus
Primary outcomes
1
Description
Well-Being
Timepoint
Before and after the intervention
Method of measurement
General Well-Being Questionnaire
2
Description
Life Expectancy
Timepoint
Before and after the intervention
Method of measurement
Life Expectancy Questionnaire
3
Description
General health
Timepoint
Before and after the intervention
Method of measurement
general health Questionnaire(GHQ)
Secondary outcomes
empty
Intervention groups
1
Description
Type of intervention:group cognitive behavior therapy Duration: eight weeks, 12 sessions Two days a week, for 45-60 minutes / session
Category
Other
2
Description
Type of intervention:aerobic exercise Duration: eight weeks intensity 60-80% heart rate reserve, frequency 3 days/week, duration 45-60 min/session
Category
Other
3
Description
The control group does not receive any treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Reza Hospital
Full name of responsible person
Mohammad Hossien Dehghan
Street address
Kermanshah, shahid shirodi Blvd, mediciene college
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
Full name of responsible person
Dr.Frid Najafi
Street address
Kermanshah, shihid beheshti Blvd, Building No. 2
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice – Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
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
Seyed Mojtaba Ahmadi
Position
Master of Science
Other areas of specialty/work
Street address
Kermanshah, shahid shiroudi Blvd, medicine college