Comparison of the Effectiveness of unified for transdiagnostic Psychotherapy and Mindfulness-Based Cognitive Therapy on Emotional Regulation, Distress Tolerance, Anxiety sensitivity and Rumination in Heart Disease patients with Type D Personality
Determining the difference in the effectiveness of mindfulness-based cognitive therapy and unified transdiagnostic psychotherapy on improving emotional regulation, promoting disturbance tolerance, reducing anxiety sensitivity and rumination in cardiac patients with D personality.
Design
The clinical trial has a control group, with parallel groups, not blinded and non-random assignment of people to groups. Phase 1 on 60 patients.
Settings and conduct
Among the heart patients of Simorgh Heart Clinic in Mashhad, 60 people with personality type D will be selected and placed in 3 research groups. All 3 groups are measured before, after and 2 months after the implementation of the intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: obtaining the required cutoff score in questionnaire D, not participating in concurrent psychotherapy sessions, not having a clinical diagnosis similar to other disorders, not having a history of hospitalization and episodes of psychosis...
Exclusion criteria: sudden occurrence of trauma, bereavement, severe recurrence of heart disease.
Intervention groups
The intervention groups include integrated metadiagnostic group (20 people), cognitive therapy group based on mindfulness (20 people) and control group (20 people).
Main outcome variables
2 independent changes (treatment method) (treatment method) (psychological treatment study and transdiagnostic treatment) and four dependent variables (emotion regulation, disturbance tolerance and treatment of a worry and thought disorder)
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231209060306N1
Registration date:2024-01-03, 1402/10/13
Registration timing:prospective
Last update:2024-01-03, 1402/10/13
Update count:0
Registration date
2024-01-03, 1402/10/13
Registrant information
Name
masume bigonah
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 915 558 2396
Email address
masoomehbigonah@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-21, 1403/04/01
Expected recruitment end date
2024-07-22, 1403/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of unified for transdiagnostic Psychotherapy and Mindfulness-Based Cognitive Therapy on Emotional Regulation, Distress Tolerance, Anxiety sensitivity and Rumination in Heart Disease patients with Type D Personality
Public title
Comparison of the Effectiveness of unified for transdiagnostic Psychotherapy and Mindfulness-Based Cognitive Therapy on Emotional Regulation, Distress Tolerance, Anxiety sensitivity and Rumination in Heart Disease patients with Type D Personality
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Obtaining the required cutoff score in the personality questionnaire D
Existence of heart disease
Non-participation in concurrent psychotherapy sessions and no history of more than three treatment sessions in the person's history.
Not having the same clinical diagnosis with substance withdrawal disorders, dementia, depression disorder and adjustment disorder based on Ballinger's and expert diagnosis.
Minimum middle school literacy.
Not taking medical drugs at the same time and drug abuse and addiction
Not having a history of hospitalization and episodes of psychosis
Minimum age of 40 and maximum of 70 years
Exclusion criteria:
Absence of more than two sessions in therapy sessions.
Sudden occurrence of trauma, bereavement and adjustment problems for people during the time period of the sessions
Severe recurrence of heart disease.
Failure to carry out relevant instructions and exercises in meetings.
Age
From 40 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Not randomized
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
Specialized committee of ethics in biomedical research of Torbete Jam University
Street address
Islamic azad university of torbate jam
City
Torbate jam
Province
Razavi Khorasan
Postal code
9188754575
Approval date
2023-04-26, 1402/02/06
Ethics committee reference number
IR.IAU.TJ.REC.1402.002
Health conditions studied
1
Description of health condition studied
Heart disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Emotion regulation
Timepoint
The beginning of the intervention (before starting the treatment) and the last session of the study and for follow-up after one month
Method of measurement
Cognitive emotion regulation questionnaire (Garnefsky et al, 2001)
2
Description
Confusion tolerance
Timepoint
The beginning of the intervention (before starting the treatment) and the last session of the study and for follow-up after one month
Method of measurement
Tolerance questionnaire by Simmons and Gaher (2005)
3
Description
Anxiety Sensitivity
Timepoint
The beginning of the intervention (before starting the treatment) and the last session of the study and for follow-up after one month
Method of measurement
Rees and Patterson Anxiety Sensitivity Questionnaire (1985)
4
Description
Rumination
Timepoint
The beginning of the intervention (before starting the treatment) and the last session of the study and for follow-up after one month
Method of measurement
Nolen-Hoeksma questionnaire (1991)
Secondary outcomes
empty
Intervention groups
1
Description
The first intervention group: this group will receive cognitive behavioral therapy based on mindfulness, which is designed based on the protocol of Segal and Teasdell (2002) in 8 sessions of 90 minutes.
Category
Behavior
2
Description
The second intervention group: this group will receive integrated metadiagnostic treatment according to the protocol of Barlow et al. (2012) in 10 sessions of 60 minutes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Simorgh Heart Clinic, Mashhad
Full name of responsible person
Dr.Javad Ramezani
Street address
Imam Reza Hospital Square
City
Mashhad
Province
Razavi Khorasan
Postal code
9188754575
Phone
+98 915 515 9422
Email
Ramezanij@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Javad Nik Andish
Street address
Kilometer 10 Torbate Jam Road, Islamic Azad University, Torbat Jam Branch
City
Torbate jam
Province
Razavi Khorasan
Postal code
91887544575
Phone
+98 915 558 2396
Email
Nikandis_s@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
50
Public or private sector
Public
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
Masoome Bigonah Rudmajani
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 251, Seyed Razi Ave 33., Seyed Rzi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188754575
Phone
+98 915 558 2396
Email
Masoomehbigonah@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoome Bigonah Rudmajani
Position
Phd student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 251, Seyed Razi Ave 33.
City
Mashhad
Province
Razavi Khorasan
Postal code
9188754575
Phone
+98 915 558 2396
Email
Masoomehbigonah@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoome Bigonah Rudmajani
Position
Phd Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 251, Seyed Razi Ave 33., Seyed Rzi Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9188754575
Phone
+98 915 558 2396
Email
Masoomehbigonah@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
"There is no further information".
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 part of the data, such as the information related to the main outcome, can be shared. Study protocol, statistical analysis, report of research findings can be published
When the data will become available and for how long
Access starts after the end of research and publication of articles
To whom data/document is available
All students and professors and those interested in the field of health psychology
Under which criteria data/document could be used
Expansion of existing therapeutic areas in psychology