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Comparison of the Effectiveness of Cognitive Behavioral Therapy and Dialectical Behavior Therapy on Perceived Stress and Coping Skills in Patients after Myocardial Infarction

Protocol summary

Study aim
Determination of the effectiveness of dialectical behavior therapy on perceived stress and coping skills in patients after myocardial infarction
Design
Clinical trials with control group, with parallel groups, without blindness, randomized
Settings and conduct
In this study, 45 patients were selected by simple random sampling method in Noor Speciality Heart Clinic in Rasht.First, by random number table, individuals were randomly divided into three groups, and in each group, 15 patients were randomly assigned.
Participants/Inclusion and exclusion criteria
Entry requirements: Patients with myocardial infarction, Having at least a third level of secondary education, Age range 30 to 60 years (due to the greater prevalence of the disease in this age range), receiving scores of one standard deviation higher than mean in the mental health test. Non-compliance: Patients with fictitious disorders, patients with acute pain, patients suffering from mood disorders and anxiety undergoing psychiatric or other psychological treatment, absence in training sessions
Intervention groups
In this study, 45 patients were selected by simple random sampling method in Noor Speciality Heart Clinic in Rasht and were assigned to one control group and two intervention groups (15 people in each group). Two intervention groups included the intervention group1: cognitive-behavioral therapy group, the intervention group2: dialectical behavioral therapy, each received eight 90-minute weekly training sessions for 2 months and the control group did not receive any intervention. Subjects in each group were evaluated by the Perceived Stress questionnaire and Coping Skills questionnaire at before, after and 3 months after the intervention.
Main outcome variables
Perceived Stress and Coping Skills

General information

Reason for update
Acronym
CBT (Cognitive Behavioral Therapy);DBT (Dialectical BehaviorTherapy);MI(Myocardial Infarction)
IRCT registration information
IRCT registration number: IRCT20180205038626N5
Registration date: 2020-05-14, 1399/02/25
Registration timing: registered_while_recruiting

Last update: 2020-05-14, 1399/02/25
Update count: 0
Registration date
2020-05-14, 1399/02/25
Registrant information
Name
Zahra Ahmadnia
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3361 8177
Email address
zahmadnia@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-07, 1399/02/18
Expected recruitment end date
2020-08-08, 1399/05/18
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Cognitive Behavioral Therapy and Dialectical Behavior Therapy on Perceived Stress and Coping Skills in Patients after Myocardial Infarction
Public title
Comparison of the Effectiveness of Cognitive Behavioral Therapy and Dialectical Behavior Therapy on Stress in Patients after Myocardial Infarction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with myocardial infarction, Having at least a third level of secondary education, Age range 30 to 60 years (due to the greater prevalence of the disease in this age range), receiving scores of one standard deviation higher than mean in the mental health test
Exclusion criteria:
Patients with fictitious disorders, Patients with acute pain, Patients who were under psychiatric treatment or other psychological treatment due to mood disorders and anxiety, Absence from training sessions
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: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Based on random blocks method and considering 6 blocks, 8 blocks will be produced for 48 patients.After providing the list, a special code is assigned to each person, and for the application of concealment, sealed envelopes that are numbered orderly will be used.
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 Rasht islamic azad University
Street address
Darvazeh Lakan, Islamic Azad University,Rasht
City
Rasht
Province
Guilan
Postal code
41476-54919
Approval date
2020-05-06, 1399/02/17
Ethics committee reference number
IR.IAU.RASHT.REC.1399.006

Health conditions studied

1

Description of health condition studied
Myocardial Infarction
ICD-10 code
121
ICD-10 code description
Ischaemic heart diseases

Primary outcomes

1

Description
Perceived Stress and Coping Skills
Timepoint
before intervention,end of each psychotherapy session and three months after intervention
Method of measurement
Perceived Stress Questionnaire and Coping Skills Questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In this study, 45 patients were selected by simple random sampling method in Noor Speciality Heart Clinic in Rasht and were assigned to one control group and two intervention groups (15 people in each group). Two intervention groups included the intervention group1: cognitive-behavioral therapy group, the intervention group2: dialectical behavioral therapy, each received eight 90-minute weekly training sessions for 2 months. Subjects in each group were evaluated by the Perceived Stress questionnaire and Coping Skills questionnaire at before, after and 3 months after the intervention.
Category
Treatment - Other

2

Description
Control group: The control group did not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Noor specialist heart clinic
Full name of responsible person
Azam Nouri Saeed
Street address
Moalem Ave., Noor specialist heart clinic, Rasht
City
Rasht
Province
Guilan
Postal code
-
Phone
+98 13 3353 4441
Email
gums.icrc@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Seyed Mozaffar Mir Bargkar
Street address
Darvazeh Lakan Ave., Islamic Azad University, Rasht,
City
Rasht
Province
Guilan
Postal code
41476-54919
Phone
+98 13 3342 2153
Email
icrc.info2019@gmail.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
100
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
Azam Nouri Saeed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dr. Heshmat Rasht Hospital, Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
gums.icrc@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam Nouri Saeed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dr. Heshmat Rasht Hospital, Valiasr Square, Baniyan St.
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 13 3361 8177
Email
gums.icrc@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Azam Nouri Saeed
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Dr. Heshmat Rasht Hospital, Masala Square, Baniyan St
City
Rasht
Province
Guilan
Postal code
4193955588
Phone
+98 31 3361 8177
Email
gums.icrc@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
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