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Comparison of the Effectiveness of Integrative Behavioral Couple Therapy (IBCT), Narrative Couple Therapy (NCT) and Couple Schema Therapy (ST-C) on Quality of Life, Affective Capital, Depression, Stress, Hope and Marital Intimacy among Coronary Artery Patients & their Spouses

Protocol summary

Study aim
Comparison of the Effectiveness of Integrative Behavioral Couple Therapy , Narrative Couple Therapy and Couple Schema Therapy on Quality of Life, Affective Capital, Depression, Stress, Hope and Marital Intimacy among Coronary Artery Patients & their Spouses
Design
The research design is quasi-experimental with pre-test, post-test and follow-up measurements compared to the control group. From patients referred to Isfahan Cardiovascular Rehabilitation Center, 80 people (including their spouses) are randomly selected and randomly assigned to 3 experimental groups and a control group.
Settings and conduct
This study compares integrated behavioral couple therapy, couple narrative therapy and couple schema therapy on the psychological variables of coronary artery disease patients and their spouses. The study is performed at the Cardiovascular Rehabilitation Center in Isfahan. Measurements are made in 3 stages: pre-test, post-test and follow-up. Interventions are in 8 90-minute sessions 8 weeks and the control group is without training. Participants are blind to the interventions.
Participants/Inclusion and exclusion criteria
Inclusion criteria: diagnosis of cardiovascular disease; Age between 25 and 65 years; diploma education at least; Non Inclusion criteria: use of psychiatric drugs; Acute or chronic mental disorders; Use of concomitant psychological therapies
Intervention groups
Three experimental groups and one control group The groups included 18 patients with their spouses. Group 1 received integrated behavioral therapy, group 2 received couple narrative therapy, group 3 received couple schema therapy (8 sessions of 90 minutes for 8 weeks), and the control group received no training.
Main outcome variables
Quality of Life, Affective Capital, Depression, stress, Hope, Marital Intimacy

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180428039458N2
Registration date: 2022-04-04, 1401/01/15
Registration timing: registered_while_recruiting

Last update: 2022-04-04, 1401/01/15
Update count: 0
Registration date
2022-04-04, 1401/01/15
Registrant information
Name
Maryam Baghooli Kermani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3235 6684
Email address
6maryam5@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-11, 1400/12/20
Expected recruitment end date
2022-05-10, 1401/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Integrative Behavioral Couple Therapy (IBCT), Narrative Couple Therapy (NCT) and Couple Schema Therapy (ST-C) on Quality of Life, Affective Capital, Depression, Stress, Hope and Marital Intimacy among Coronary Artery Patients & their Spouses
Public title
Comparison of the Effectiveness of Integrative Behavioral Couple therapy, Narrative Couple therapy and Couple Schema Therapy in Coronary Artery Patients & their Spouses.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of cardiovascular disease Being in the age range of 25 to 65 years old diploma education at least
Exclusion criteria:
Using psychiatric drugs Acute or chronic mental disorders (approved by a clinical psychologist) Using concomitant psychological therapies
Age
From 25 years old to 65 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 80
Randomization (investigator's opinion)
Randomized
Randomization description
Couples (about 80 couples) were purposefully selected based on the inclusion criteria and then selected by simple random method (lottery: according to the sampling framework among the community, a sample of the desired volume was selected from among the listed individuals (based on inclusion criteria) and then by lot (writing names on lottery cards and random selection of names) are divided into four groups (three intervention groups and one control group).
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blind to grouping and reporting.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committees of Islamic Azad University - Isfahan (Khorasgan) Branch
Street address
Unit 1; Mahestan Building; Motahary Street; Felezi bridge; Isfahan
City
Isfahan
Province
Isfehan
Postal code
8184854783
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.311

Health conditions studied

1

Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease of native coronary artery

Primary outcomes

1

Description
Depression
Timepoint
Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention).
Method of measurement
Beck Depression Inventory

2

Description
Quality of life
Timepoint
Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention).
Method of measurement
Ware & Sherbourne Inventory

3

Description
Affective capital
Timepoint
Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention
Method of measurement
Golpavar Affective capital Inventory

4

Description
Hope
Timepoint
Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention
Method of measurement
Snyder hope Inventory

5

Description
Marital intimacy
Timepoint
Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention
Method of measurement
Thompson & Walker Inventory

6

Description
Stress
Timepoint
Measurements will be performed in the pre-test (pre-intervention), post-test (8 weeks after the intervention) and follow-up (16 weeks after the intervention
Method of measurement
Leung, Lam & Chan Inventory

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Integrative behavioral couple therapy: Integrative behavioral couple therapy sessions are in the form of 8 90-minute tissue-based sessions and help couples to increase their satisfaction and adjustment. This approach includes three intervention strategies (empathetic unity, allied neutrality, and tolerance) designed to increase acceptance between couples. These sessions will be based on the integrated behavioral therapy protocol of Christensen and Jacobsen (1998).
Category
Behavior

2

Description
Intervention group: Couple narrative therapy: Couple narrative therapy sessions in the present study in the form of 8 90-minute sessions based on using a set of methods for understanding people's stories, deconstructing and rewriting these stories by the individual and with the help of the therapist . These sessions will be based Friedman and Combs treatment protocol(2008).
Category
Behavior

3

Description
Intervention group: Couple Schema Therapy: Couple schema therapy sessions in the present study in the form of 8 90-minute sessions based on the correction and modification of early maladaptive schemas that play a role in creating and perpetuating couples' communication problems. These sessions will be based on the guidelines of Young (2003) and Simeone-Difrancesco, Roeder, Stevens (2015).
Category
Behavior

4

Description
Control group: The control group (waiting list) does not receive any intervention.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Isfahan Cardiovascular Research Center
Full name of responsible person
Masoumeh Sadeghi
Street address
Shahid Rahmani Alley, next to Shahid Chamran Heart Center, after the Shahrestan bridge, the third Moshtaq Ave
City
Isfahan
Province
Isfehan
Postal code
صندوق پستی: ۱۱۴۸-۸۱۴
Phone
+98 31 3611 5313
Fax
Email
crc@mui.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Payam Najafi
Street address
Daneshgah Blvd; Arghavanieh; Jey St, Isfahan, Iran
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Fax
+98 31 3535 4060
Email
info@khuisf.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
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
Maryam Baghooli Kermani
Position
PhD-student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khorasgan Azad University; Daneshgah Blvd; Arqavanieh Blvd; Jey street
City
Isfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
6maryam5@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohsen Golparvar
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Khorasgan Azad University; Daneshgah Blvd; Arqavanieh Blvd; Jey street
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
drmgolparvar@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Baghooli Kermani
Position
PhD.Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khorasgan Azad University; Daneshgah Blvd; Arqavanieh Blvd; Jey street
City
Esfahan
Province
Isfehan
Postal code
81551-39998
Phone
+98 31 3535 4001
Email
info@khuisf.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
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
The total data can be potentially shared after making it "unidentifiable"
When the data will become available and for how long
Start the access period 6 months after publishing of the results
To whom data/document is available
It will be accessible for everyone
Under which criteria data/document could be used
There will be no specific condition
From where data/document is obtainable
Maryam Baghooli Kermani, Email: 6maryam@gmail.com
What processes are involved for a request to access data/document
There will not be any specific process, we will be responsive after receiving an email
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