Randomized controlled trial comparing the effectiveness of Mindfulness based stress reduction and Cognitive behavioral therapy on anger, perceived stress, quality of life and blood pressure in cardiac patients
Objectives: This study aimed to compare the effectiveness of Mindfulness based stress reduction (MBSR) and Cognitive behavioral therapy (CBT) on anger, perceived stress, quality of life and blood pressure in cardiovascular patients at Kashan. (2) Design: General plan of this study is consisted of experimental pre-test and post-test with follow-up period. (3) Setting and conduct: Sixty subjects who met the criteria for cardiovascular disease and were able to complete the program were selected by convenient sampling and were randomly assigned in two groups (MBSR and CBT). Participants in two groups filled out Cohen's perceived stress scale, Spielberger's State and Trait Anger Expression Inventory (STAXI-2), and McNew Quality of life questionnaire as pre-test and post- test and two month after intervention. The data were analyzed by SPSS-15 using the Multivariate Analysis of Covariance (MANCOVA). (4) Participants including major eligibility criteria: Inclusion criteria: Cardiac patients with controlled symptoms; Age 35-60 years. Exclusion criteria: A history of substance abuse; Get a history of psychological interventions during the past month. (5) Interventions: The first intervention is consisted of 8 sessions (each session is 120 minutes) of Mindfulness based stress reduction for the first experimental group. The second intervention is consisted of 8 sessions (each session is 120 minutes) of Cognitive behavior therapy for the second experimental group. (6) Main outcome measures: Main outcome measures variables in this research are anger, perceived Stress, quality of life and blood pressure
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015012520794N1
Registration date:2015-03-23, 1394/01/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2015-03-23, 1394/01/03
Registrant information
Name
Javad Momeni
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 31 5554 0021
Email address
javad.momeni@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Expected recruitment start date
2015-02-24, 1393/12/05
Expected recruitment end date
2015-03-01, 1393/12/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Randomized controlled trial comparing the effectiveness of Mindfulness based stress reduction and Cognitive behavioral therapy on anger, perceived stress, quality of life and blood pressure in cardiac patients
Public title
Comparing the effectiveness of Mindfulness based stress reduction and Cognitive behavioral therapy on anger, perceived stress and quality of life and blood pressure in cardiac patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Cardiac patients with controlled symptoms; age 35-60 years; Willing and able to participate in the mindfulness based stress reduction programme and cognitive behavior therapy; Minimum education level diploma. Exclusion criteria: Renal diseases; Active malignant disease such as cancer; History of epilepsy or seizures during the 6 months prior to the first meeting; Pregnancy or lactation period; A history of substance abuse; Get a history of psychological interventions during the past month
Age
From 35 years old to 60 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kashan University of Medical Sciences and Health Services
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan, Iran
City
Kashan
Postal code
8715988141
Approval date
2015-01-07, 1393/10/17
Ethics committee reference number
4912
Health conditions studied
1
Description of health condition studied
Heart Disease
ICD-10 code
I20,I21,I2
ICD-10 code description
For morbidity, duration as used in categories I21, I22,I24 and I25 refer to the interval elapsing between onset of the ischaemic episode and admission to care. For mortality, duration refers to the interval elapsing between onset and death.
2
Description of health condition studied
Anger
ICD-10 code
ICD-10 code description
3
Description of health condition studied
Perceived Stress
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Perceived Stress
Timepoint
before intervention, After intervention, 2 month after intervention
Method of measurement
Perceived Stress Scale by Cohen
2
Description
Anger
Timepoint
Before intervention, After intervention, 2 month after intervention
Method of measurement
Spielberger's State and Trait Anger Expression Inventory (STAXI-2)
3
Description
Quality of Life
Timepoint
Before intervention, After intervention, 2 month after intervention
Method of measurement
McNew Quality of Life Questionnaire
4
Description
Added at 2015-12-25: blood pressure
Timepoint
Added at 2015-12-25: Before intervention, After intervention, 2 month after intervention
Method of measurement
Added at 2015-12-25: measure by blood pressure monitor
Secondary outcomes
empty
Intervention groups
1
Description
Mindfulness Based Stress Reduction; 8 sessions; 2 hours, First intervention group
Category
Behavior
2
Description
Cognitive Behavioral Therapy; 8 sessions; 2 hours; Second intervention group
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr Rayegan Cardiology and Angiology Center
Full name of responsible person
Dr Fariba Rayegan
Street address
Dr Rayegan Cardiology and Angiology Center, Shahid Beheshti St, Kashan, Iran
City
Kashan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
Full name of responsible person
Dr Qolam Ali Hamidi
Street address
Vice chancellor for research of Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice chancellor for research of Kashan University of Medical Sciences and Health Services
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
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Javad Momeni
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
javad.epost@gmail.com; javad.momeni@kaums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Javad Momeni
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
javad.epost@gmail.com; javad.momeni@kaums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Kashan University of Medical Sciences and Health Services
Full name of responsible person
Javad Momeni
Position
M.Sc Candidate in Clinical Psychology
Other areas of specialty/work
Street address
Department of Clinical Psychology, School of Medicine, Kashan University of Medical Sciences and Health Services, Pezeshk Blvd, 5th of Qotbe Ravandi Blvd, Kashan
City
Kashan
Postal code
Phone
+98 31 5554 0021
Fax
Email
javad.epost@gmail.com; javad.momeni@kaums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)