Protocol summary

Study aim
Evaluation of the effectiveness of guided subjective imaginary and acceptance and commitment based therapy on the perception of disease, resilience and emotional regulation (positive and negative) of cardiac patients referring to the heart rehabilitation department
Design
This is a randomized clinical trial with 2 intervention groups, a control group, parallel groups with simple randomization. The sample size is 45.
Settings and conduct
45 patients are selected from the patients referring to heart rehabilitation department of Imam Reza hospital and are assigned to 3 groups of acceptance and commitment based therapy, guided subjective imaginary therapy and control with no treatment. All groups go through a pre-test and complete resilience, perception of disease and emotional regulation questionnaires. After the intervention, the post-test stage is done for the three groups. In the follow up stage after one month, the questionnaires are completed by the three groups again.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having cardiac disease. Exclusion criteria: Having psychological diseases, Using psychological drugs, Having mental illnesses, Addiction to drugs and alcohol.
Intervention groups
Intervention group 1: Fifteen patients are randomly assigned to the guided subjective imaginary therapy group in which intervention is done through 10 sessions of one-hour treatment twice a week with Simonton package (2000) for 40 days Intervention group 2: Fifteen patients are randomly assigned to the acceptance and commitment based therapy group in which intervention is done through 8 sessions of one-hour treatment twice a week with Sahebi package (2012) for one month Control group: Fifteen patients are randomly assigned to the control group in which no treatment takes place.
Main outcome variables
Patient resilience, perception of disease, emotional regulation

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190727044345N1
Registration date: 2019-09-17, 1398/06/26
Registration timing: registered_while_recruiting

Last update: 2019-09-17, 1398/06/26
Update count: 0
Registration date
2019-09-17, 1398/06/26
Registrant information
Name
Abbasali Shahabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3891 4990
Email address
shahabiaa1@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-08-06, 1398/05/15
Expected recruitment end date
2019-11-21, 1398/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effectiveness of guided subjective imaginary and acceptance and commitment based therapy on the perception of disease, resilience and emotional regulation of cardiac patients referring to the heart rehabilitation department
Public title
Effectiveness of some psychological therapies on psychological recovery of cardiac patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Having cardiac disease Having a minimum of diploma degree
Exclusion criteria:
Having psychological disease Using psychological drugs Having mental illnesses such as epilepsy and Alzheimer's Addiction to drugs and alcohol
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: 45
Randomization (investigator's opinion)
Randomized
Randomization description
Simple randomization is carried out using table of random at 'www.randomization.com' website in a way that the produced numbers are placed inside sealed envelopes and once patients enter the study, envelopes are assigned to them which put them in one of the 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 Azad University Of Ahvaz
Street address
Azad University Of Ahvaz, Farhang Shahr, Golestan highway
City
Ahvaz
Province
Khouzestan
Postal code
۶۱۳۴۹-۳۷۳۳۳
Approval date
2019-07-16, 1398/04/25
Ethics committee reference number
IR.IAU.AHVAZ.REC.1398.012

Health conditions studied

1

Description of health condition studied
Cardiac disease patients
ICD-10 code
Z50.0
ICD-10 code description
Cardiac rehabilitation

Primary outcomes

1

Description
Patients resilience
Timepoint
Before and after intervention (pre and post test) and also in the follow up stage one month after intervention
Method of measurement
Conner-Davidson Resilience Scale

2

Description
Perception of disease
Timepoint
Before and after intervention (pre and post test) and also in the follow up stage one month after intervention
Method of measurement
Disease perception questionnaire

3

Description
Cognitive emotional regulation
Timepoint
Before and after intervention (pre and post test) and also in the follow up stage one month after intervention
Method of measurement
Cognitive emotional regulation strategies questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Patients in acceptance and commitment-based therapy group receive 8 sessions of one-hour treatment twice a week with Sahebi treatment package for one month which includes a psychological intervention that implements acceptance and awareness along with commitment and behavior change guidelines in order to increase psychological flexibility in patients.
Category
Treatment - Other

2

Description
Intervention group 2: Patients in the guided subjective imaginary therapy group receive 10 sessions of one-hour treatment twice a week with Simonton package (2000) which for 40 days incorporates mental practices for mental acceptance of presence of health and occurrence of recovery in body and use of imagination to produce scenes, sounds, smells, and tastes or other senses which provide a type of purposeful view.
Category
Treatment - Other

3

Description
Control group: No treatment is used for this group in the study.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Raza Hospital
Full name of responsible person
Abbas Ali Shahabi
Street address
Imam Reza Hospital, Imam Reza square, Ebn_e_sina Avenue
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Email
dr.shahabi20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Hossein Matori
Street address
Islamic Azad University of Persian Gulf International branch, daneshgah St. Minoo Shahr.
City
Khoramshahr
Province
Khouzestan
Postal code
6437113378
Phone
+98 61 5337 3081
Email
pazhoohesh97@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
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
Abbasali shahabi
Position
Student of PhD
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Persian Gulf International branch, daneshgah St. Minoo Shahr.
City
Khoramshahr
Province
Razavi Khorasan
Postal code
6437113378
Phone
+98 61 5337 3081
Email
dr.shahabi20@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Parvin Ehteshamzadeh
Position
Assisstant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Persian Gulf International branch, daneshgah St. Minoo Shahr.
City
Khoramshahr
Province
Khouzestan
Postal code
6437113378
Phone
+98 61 5337 3081
Email
ehtesham85@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Abbasali Shahabi
Position
Student of PhD
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Islamic Azad University of Persian Gulf International branch, daneshgah St. Minoo Shahr.
City
Khoramshahr
Province
Khouzestan
Postal code
6437113378
Phone
+98 61 5337 3081
Email
dr.shahabi20@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
Undecided - It is not yet known if there will be 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
All data can be shared after patients are made unidentifiable.
When the data will become available and for how long
Data can be accessible 6 months after results are published.
To whom data/document is available
Data will be available for researchers in universities and other scientific institutes.
Under which criteria data/document could be used
Carrying out analysis on data is permitted.
From where data/document is obtainable
Data can be accessible through sending an email to the corresponding author.
What processes are involved for a request to access data/document
After sending a request email to the corresponding author, data will be sent in 1 month.
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