The aim of the current research is to determine the effect of mindfulness-based stress reduction (MBSR) intervention on glycemic and Hemoglobin A1c level; general health improvement; and a decrease in anxiety and depressive symptoms. The study group is type-2 diabetes mellitus outpatients who are reffered to Emam Khomaini hospital of Tehran. 60 diabetic patients who have Hemoglobin A1c higher than 7 and not suffering from other chronic diseases are selected. this study is a randomized, controlled trial. Half of the selected group(30 patients) are referred to receive 8 sessions of mindfulness-based stress reduction that is conducted weekly for 8 weeks. An assessment of fasting blood sugar, Hemoglobin A1c, general health questionnaire, using the Hamilton rating scale for depression and anxiety, will be conducted at baseline, week 8 and after 3 months as follow up. Half of the selected group(30 patients) are in control group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050925812N2
Registration date:2017-07-17, 1396/04/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-07-17, 1396/04/26
Registrant information
Name
Bita Vahdani
Name of organization / entity
Zanjan University of Medical Sciences, Shahid Beheshti Hospital
Country
Iran (Islamic Republic of)
Phone
+98 24 3354 4000
Email address
bt_vahdani@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2016-05-21, 1395/03/01
Expected recruitment end date
2017-10-22, 1396/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Impact of Mindfulness-Based Stress Reduction in Emotional and Glycemic Regulation of Type-2 Diabetes Mellitus Outpatients
Public title
The Impact of Mindfulness-Based Stress Reduction in Emotional and Glycemic Regulation of Type-2 Diabetes Mellitus Outpatients
Purpose
Treatment
Inclusion/Exclusion criteria
Included criteria: Hemoglobin A1c higher than 7; having of type-2 diabetes mellitus
Exclusion criteria: suffering from other chronic diseases; history of neurological and psychiatric disorders; drug abuse; being in other psychological programs; more than two session absences in experimental group
Age
From 18 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The sampling method is available through the referral's referral center to Imam Khomeini Hospital's Endocrine Clinic, which is blind assigned to two experimental and control groups by coding and randomizing the patients
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Zanjan University of Medical Sciences
Street address
Azadi Boulevard
City
Zanjan
Postal code
15788-45136
Approval date
2016-06-02, 1395/03/13
Ethics committee reference number
Zums.rec.1396.41
Health conditions studied
1
Description of health condition studied
Type 2 Diabetes Melitus
ICD-10 code
ِE11
ICD-10 code description
Chronic type 2 Diabetes
Primary outcomes
1
Description
Fasting Blood Suger
Timepoint
Before intervention - after intervention - 3 months after intervention
Method of measurement
Photometric
2
Description
Hemoglobin A1c
Timepoint
Before intervention - after intervention - 3 months after intervention
Method of measurement
HPLC
Secondary outcomes
1
Description
Anxiety
Timepoint
Before intervention - after intervention - 3 months after intervention
Method of measurement
patients score in Hamilton Anxiety Rating Scale questionnaire
2
Description
depression
Timepoint
Before intervention - after intervention - 3 months after intervention
Method of measurement
patients score in Hamilton Depression Rating Scale questionnaire
3
Description
General Health
Timepoint
Before intervention - after intervention - 3 months after intervention
Method of measurement
patients score in General Health Questionnaire-28
Intervention groups
1
Description
control( without psychological intervention)
Category
Treatment - Drugs
2
Description
Mindfulness based stress reduction intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrinology clinic, Emam khomeini hospital
Full name of responsible person
Dr. Bita Vahdani. Bita Vahdani
Street address
tehran, emam hospital
City
tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Endocrinology clinic of Imam Khomeini Hospital
Full name of responsible person
Finance and Administration Affairs
Street address
tehran
City
tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences, Endocrinology clinic of Imam Khomeini Hospital
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
Zanjan University of Medical Sciences
Full name of responsible person
Bita Vahdani
Position
psychiatry Resident
Other areas of specialty/work
Street address
zanjan University of Medical Sciences, Psychiatry Department