Comparing the effectiveness of short-term dynamic psychotherapy and schema therapy on perceived stress and reduction of physical symptoms of hypertensive patients referring to comprehensive health service centers in Sari city
Comparing the effectiveness of short-term dynamic psychotherapy and schema therapy on perceived stress and reduction of somatic symptoms in hypertensive patients
Design
Clinical trial with a control group, with crossover groups, unblinded, randomized, phase 2 on 45 patients. The rand function of Excel software was used for randomization.
Settings and conduct
Health centers, Sari city
Participants/Inclusion and exclusion criteria
The statistical population includes all hypertensive patients referring to comprehensive health service centers in Sari city. The entry criteria are: suffering from high blood pressure disease registered by a doctor. Exit criteria: existence of psychiatric disorder in the patient; existence of physical diseases; receiving training based on communication and psychology issues at the same time in other schools; absence of more than two sessions in training sessions.
Intervention groups
The sample people are placed in the first three experimental groups (15 people), the second experimental group (15 people) and the control group (15 people). First, all sample people in all three groups are examined in the pre-test stage. In the next stage, the first experimental group will receive a short-term dynamic psychotherapy training intervention, the second group will receive schema therapy training, and finally, a post-test will be performed from all three groups.
Comparing the effectiveness of short-term dynamic psychotherapy and schema therapy on perceived stress and reduction of physical symptoms of hypertensive patients referring to comprehensive health service centers in Sari city
Public title
Comparing the effectiveness of short-term dynamic psychotherapy and schema therapy on perceived stress and reduction of physical symptoms of hypertensive patients referring to comprehensive health service centers in Sari city
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from high blood pressure disease registered by a doctor.
Exclusion criteria:
Psychiatric disorder in the patient
Physical diseases
Receiving training based on communication and psychology issues at the same time in other schools
Absence of more than two sessions in training sessions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple, Cluster randomization, Random number table and Spss software, Random assignment to intervention and control groups
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 Mazandaran University of Medical Sciences
Street address
Mazandaran University of Medical Sciences, Serah Joibar, Imam Square
City
Sari
Province
Mazandaran
Postal code
4816797411
Approval date
2024-05-05, 1403/02/16
Ethics committee reference number
IR.IAU.SHK.REC.1402.144
Health conditions studied
1
Description of health condition studied
High blood pressure
ICD-10 code
111
ICD-10 code description
Hypertensive heart diseaseIncl.:any condition in I50.-, I51.4-I51.9 due to hypertension
Primary outcomes
1
Description
The stress score in Thomas et al.'s Life Stress Questionnaire (LDI), which has a maximum score of 126.
Timepoint
Before starting the intervention, one week after the intervention
Method of measurement
Thomas et al.'s life stress questionnaire (LDI)
Secondary outcomes
1
Description
Perceived stress and reduced physical symptoms
Timepoint
Before the intervention and one week after
Method of measurement
Powell and Enright Physical Symptoms Questionnaire
Intervention groups
1
Description
Intervention group: Intervention group: Schema therapy sessions in accordance with Yang's therapy model and Duvanlo's (1996) intensive short-term dynamic psychotherapy are held in groups for 11 sessions of 90 minutes.
Category
Treatment - Other
2
Description
Control group: Control group: The pre-test stage is performed but without the training of dependent variables, and the post-test is performed at the end.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
The health centers were located in cities 6 and 7 of Sari city
Full name of responsible person
Mr. Dr. Mahmoudreza Hashem Varzi
Street address
Shahband St., Health Vice-Chancellor of Sari
City
sari
Province
Mazandaran
Postal code
4816797411
Phone
+98 939 611 3649
Email
mo_rahmani94@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr. pedram ebrahim nezhad
Street address
Shahband St. - Mazandaran health department
City
sari
Province
Mazandaran
Postal code
4816797411
Phone
+98 911 215 3368
Email
pedram_hoseini@yahoo.com
Grant name
Mazandaran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
80
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
Mazandaran University of Medical Sciences
Full name of responsible person
Mahmood reza Hashem varzi
Position
emoolayee
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahband St. - Mazandaran health department
City
sari
Province
Mazandaran
Postal code
4815694911
Phone
+98 911 215 9836
Email
mo_RELAX892@YAHOO.COM
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
mahmood reza hashemvarzi
Position
empolayee
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahband St. - Mazandaran health department
City
ساري
Province
Mazandaran
Postal code
4815694911
Phone
+98 911 215 9836
Email
mo_rahmani94@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mahmood Reza Hashemvarzi
Position
Empolayee
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Shahband St. - Mazandaran health department
City
Sari
Province
Mazandaran
Postal code
4816797411
Phone
+98 911 215 9836
Email
RELAX_892@YAHOO.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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
After completing the research and recording it, the data analysis can be accessed as a complete article.
When the data will become available and for how long
After completing the research, another six months
To whom data/document is available
Tutors and advisors
Under which criteria data/document could be used
nobody
From where data/document is obtainable
researcher
What processes are involved for a request to access data/document
After the completion of the project and registration in a valid journal, it is possible to obtain it.