The effectiveness of mindfulness-based cognitive-behavioral therapy on social anxiety, cognitive flexibility and happiness in patients with coronary heart disease
The experimental (n = 15) and control (n = 15) groups were selected by convenience and simple random sampling.
Settings and conduct
Research method: semi-experimental type with a pre-test, post-test design with a control group. The statistical population is all patients with coronary heart disease referred to Heshmat Hospital in Rasht city, who referred to this hospital in July and August 1400. The tool for collecting materials and information was scanning authentic books and articles, as well as referring to authentic sites, and in order to collect data, the students' adaptation questionnaire was used by Dennis and Vanderwaal (2010), the Oxford happiness questionnaire and the social anxiety questionnaire of Conor et al. 2000) was used.
Participants/Inclusion and exclusion criteria
Entry criteria: the person must be suffering from coronary heart disease; the person must be a resident of Rasht city; the person must be interested in participating in this research. Exclusion criteria: not being able to read and write; taking psychiatric drugs.
Intervention groups
After the pre-test (questionnaire), the MBCT training protocol in 8 sessions of 90 minutes is provided as an audio file to the experimental group, which is based on the 8-week MBCT program for adults, and at the end, members will be re-evaluated by a questionnaire.
Main outcome variables
Cognitive flexibility; social anxiety; happiness
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210824052280N1
Registration date:2022-10-17, 1401/07/25
Registration timing:retrospective
Last update:2022-10-17, 1401/07/25
Update count:0
Registration date
2022-10-17, 1401/07/25
Registrant information
Name
Reyhane Darrudi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3387 6158
Email address
reyhane72azar@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-10-23, 1400/08/01
Expected recruitment end date
2021-11-21, 1400/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of mindfulness-based cognitive-behavioral therapy on social anxiety, cognitive flexibility and happiness in patients with coronary heart disease
Public title
The effect of mindfulness on social anxiety, cognitive flexibility and happiness
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The person must have coronary heart disease.
The person must be a resident of Rasht.
The person must be interested in participating in the research.
Exclusion criteria:
Inability to read and write.
Taking psychiatric drugs.
Age
No age limit
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
The randomization method is a simple randomization. The study has two groups and from the beginning it is agreed that odd numbers will be given to the intervention group and even numbers will be given to the control group. Then, using random numbers table, the relevant numbers are extracted, each number is written on a card and placed in an envelope, and the envelopes are sealed, and the patient's number is written on each envelope, and the first patient who enters the study Envelope number 1, patient number 2, envelope number 2 and so on will be given. Finally, people in two intervention groups (15 people) and control group (15 people) will enter the research.
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
Ethics Committee of Lahijan Azad University
Street address
Health Building 7, Kamranieh, Talshan
City
Rasht
Province
Guilan
Postal code
4193168619
Approval date
2021-09-08, 1400/06/17
Ethics committee reference number
IR.IAU.LIAU.REC
Health conditions studied
1
Description of health condition studied
Coronary heart disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery
Primary outcomes
1
Description
Cognitive flexibility score in Dennis and Vanderwaal's cognitive flexibility questionnaire
Timepoint
Before and after the intervention
Method of measurement
Cognitive flexibility questionnaire of Dennis and Vanderwaal
2
Description
Oxford happiness questionnaire score
Timepoint
Before and after the intervention
Method of measurement
Oxford Happiness Questionnaire
3
Description
Conover's Social Anxiety Questionnaire
Timepoint
Before and after the intervention
Method of measurement
Conover's Social Anxiety Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group receives cognitive behavioral therapy based on mindfulness. The therapy sessions are as follows: each session lasts for 45 minutes and two sessions per week during four consecutive weeks for a total of eight sessions. The content of the interventions of each session is as follows: First session: physical examination training and focus on short breathing, reading and meditation reflection, breathing exercise training and doing it, breathing exercise assignment, notes of emotions during exercise. The second session: practicing thoughts and feelings, people's feedback from the practice, getting to know how to relax. The third session: conscious movement, meditation and checking the body, discovering the experiences of thoughts and creating images and feelings of the present. The fourth session: practice of seeing and hearing, meditation and understanding the present moment, practice with sitting meditation. The fifth session: Reviewing the exercise and examining its effects on the body; Three-minute breathing exercise. Sixth session: training in body scanning technique, searching for physical senses (hearing and taste), observing opposite thoughts and alternative views. Seventh session: Observing the creation of alternative thoughts and views, making a list of energizing (creating a sense of pleasure and mastery) and boring activities. 8th session: body inspection meditation, final meditation, review of the entire course.
Category
Treatment - Other
2
Description
Control group: In this study, people in the control group do not receive any intervention and it is created only for the purpose of comparison to determine the effectiveness of the treatment used in the intervention group.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Dr. Heshmat Educational & Remedial Center
Full name of responsible person
Dr. Rasoul Yousefi
Street address
Bayani Street
City
Rasht
Province
Guilan
Postal code
413955588
Phone
+98 13 3366 3070
Email
heshmat@gums.ac.ir
Web page address
https://heshmat.gums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University, Lahijan Branch
Full name of responsible person
Gholamreza Vaghar Lahiji
Street address
East Kashif Street, the end of Shaghayegh Street
City
Lahijan
Province
Guilan
Postal code
3951544169
Phone
+98 13 4222 9074
Email
info@liau.ac.ir
Web page address
http://www.liau.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University, Lahijan Branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad.Mahdi Pasandideh
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
East Kashef St.
City
Lahijan
Province
Guilan
Postal code
3951544169
Phone
+98 13 4222 9081
Email
mmpasandideh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad.Mahdi Pasandideh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
East Kashef St.
City
Lahijan
Province
Guilan
Postal code
3951544169
Phone
+98 13 4222 9081
Email
mmpasandideh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Reyhane Darrudi
Position
Collegian
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Complex, Lahijan branch, the end of Sheghaig St., Eastern Kashef St.
City
Lahijan
Province
Guilan
Postal code
3951544169
Phone
+98 13 3387 6158
Fax
Email
Reihane72azar@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only general specifications such as information about the main outcome are shared.
When the data will become available and for how long
The access period begins three months after the publication of the results
To whom data/document is available
The use of the results is free for the public, and it is also available to all researchers in the research field under study.
Under which criteria data/document could be used
Its use is unrestricted, citing the source.
From where data/document is obtainable
Islamic Azad University Lahijan branch
What processes are involved for a request to access data/document
Refer to the Open University Branch Library, Theses section