Comparison the effectiveness of group mindfulness-based stress reduction and group cognitive-behavioral stress management on biological markers and psychological symptoms in patients with essential hypertension
The purpose of this study is comparison the effectiveness of group mindfulness-based stress reduction and group cognitive-behavioral stress management on biological markers and psychological symptoms in patients with essential hypertension. This research is a randomized, pretest, post-test, with a control group design, in the form of randomized clinical trial. 60 patients with essential blood pressure who are not controlled their blood pressure by medication will allocate randomly to one of the 3 groups: group of mindfulness-based stress reduction (MBSR), group of cognitive-behavioral stress management and control group. 8 weekly sessions (each session 1/5 hours) group intervention based on MBSR for MBSR group and 8 weekly sessions (each session 1/5 hours) group intervention based on cognitive-behavioral stress management for another group will run. Before and after treatment, research variables such as blood pressure, interleukin 6, oxidative stress, quality of life, anxiety and perceived stress will be assessed and evaluated.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017103137145N1
Registration date:2017-11-14, 1396/08/23
Registration timing:prospective
Last update:
Update count:0
Registration date
2017-11-14, 1396/08/23
Registrant information
Name
Farshad Sheybani
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4426 9039
Email address
sheybani.f@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
This research is related to the PhD dissertation and its funding will be provided by the Iran University of Medical sciences
Expected recruitment start date
2017-11-16, 1396/08/25
Expected recruitment end date
2017-12-11, 1396/09/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison the effectiveness of group mindfulness-based stress reduction and group cognitive-behavioral stress management on biological markers and psychological symptoms in patients with essential hypertension
Public title
Effect of stress reduction on blood pressure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Diagnosis of essential hypertension with uncontrolled hypertension despite the treatment according to a cardiologist evaluation; Age between 30 and 60 years; Consent to participate in the research based on the written informed consent form.
Exclusion criteria: Secondary blood pressure; Having major depressive disorder; Generalized anxiety disorder; Panic disorder and Post traumatic stress disorder during 1 year ago; Receiving Mindfulness or cognitive-behavioral therapy by a psychologist or psychiatrist in the past.
Age
From 30 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
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Iran University of Medical Sciences
Street address
Shahid Hemmat Highway, Tehran.
City
Tehran
Postal code
1333813444
Approval date
2017-06-21, 1396/03/31
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9211521215
Health conditions studied
1
Description of health condition studied
Essential hypertension
ICD-10 code
I10
ICD-10 code description
Essential (primary) hypertension
Primary outcomes
1
Description
blood pressure
Timepoint
before and after of intervention
Method of measurement
Home Blood Pressure Monitoring (HBPM)
2
Description
stress oxidative
Timepoint
before and after of intervention
Method of measurement
proxidane and antioxidants balance (PAB)
3
Description
interleukin 6
Timepoint
before and after of intervention
Method of measurement
ELISA method using the Biovendor Germany IL-6 kit
4
Description
anxiety
Timepoint
before and after of intervention
Method of measurement
Beck Anxiety Inventory
5
Description
quality of life
Timepoint
before and after of intervention
Method of measurement
The World Health Organizetion Quality of Life Instrument – short form (WHOQOL-BREF)
6
Description
perceived stress
Timepoint
before and after of intervention
Method of measurement
perceived stress scale (PSS) cohen
Secondary outcomes
empty
Intervention groups
1
Description
The MBSR-based group intervention is based on the 8th session of Jon Kabat Zinn's approach, which lasts 1.5 hours each session.
Category
Lifestyle
2
Description
Cognitive-behavioral stress management group sessions are based on the Cognitive-Behavioral Stress Management Book (Anthony, Ironson, and Schneiderman, 2010). The duration of each session is 1.5 hours.
Category
Behavior
3
Description
The control group receives standard blood pressure treatment.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Rasoul Akram Hospital
Full name of responsible person
Farshad Sheybani
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr Behrooz Birashk
Street address
School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Ph.D student in clinical psychology
Other areas of specialty/work
Street address
School of Behavioral Sciences and Mental Health, Mansouri St, Niyayesh St, Sattarkhan St, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 4426 9039
Fax
Email
sheybani.f@tak.iums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Ph.D student of clinical psychology
Other areas of specialty/work
Street address
Sattarkhan Street, Nayest St., School of Behavioral Sciences and Mental Health
City
Tehran
Postal code
Phone
+98 21 4426 9039
Fax
Email
sheybani.f@tak.iums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Farshad Sheybani
Position
Ph.D student of clinical psychology
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)