Study of the feasibility and effectiveness of well-being therapy on psychological well-Being, optimism, positive and negative affects and depression in coronary patients
Feasibility trial and study of the effectiveness of well-being therapy on psychological wellbeing, optimism, positive and negative affects and depression in coronary patients
Design
Study design was experimental with pre-test, post-test and follow-up measurements compare with attention control group. From patients referring to Saheb al-Zaman Hospital in Shahreza 40 participants were randomly selected and assigned to the psychological well-being intervention or attention control condition randomly using concealed cards.
Settings and conduct
Psychological well-being is a protective factor for cardiovascular health. This study examined the effectiveness of well-being therapy on psychological variables of cardiac patients. This study was performed on cardiac patients referred to Saheb Al-Zaman Hospital of Shahreza. Measurements were performed at pre-test, post-test and follow-up. The intervention was created based on Ryff psychological well-being (1989). Experimental group received well-being therapy during 8 sessions (90 minutes, for 8 weeks) and attention control group received usual medical education. Participants were blind to grouping and also the study staff were blind until the end of the pre-test measurements. Statistical analysts were also blind to grouping.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1- Documented diagnosis of coronary artery disease
2- Agreement for participation in study
Exclusion criteria:
1- Receive any other psychological intervention or treatment
Intervention groups
Intervention groups included the experimental group and attention control group. Each group included 20 coronary patients. Experimental group received well-being therapy during 8 sessions (90 minutes, for 8 weeks) and attention control group received usual medical education.
Main outcome variables
1- Feasibility
2- Psychological well-being
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171010036693N2
Registration date:2018-10-07, 1397/07/15
Registration timing:retrospective
Last update:2018-10-07, 1397/07/15
Update count:0
Registration date
2018-10-07, 1397/07/15
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 913 820 7022
Email address
eshaghi1453@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-08-06, 1396/05/15
Expected recruitment end date
2017-09-06, 1396/06/15
Actual recruitment start date
2017-08-06, 1396/05/15
Actual recruitment end date
2017-09-09, 1396/06/18
Trial completion date
2018-01-08, 1396/10/18
Scientific title
Study of the feasibility and effectiveness of well-being therapy on psychological well-Being, optimism, positive and negative affects and depression in coronary patients
Public title
Study of the effectiveness of well-being therapy on coronary patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Documented diagnosis of coronary artery disease
Minimal reading and writing skills
Agree to participate in study
Exclusion criteria:
Physical problems or psychological disorders that prevent participation in intervention sessions
Receive any other psychological intervention or treatment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
40
Actual sample size reached:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Present study was a randomized pilot trial to examine psychological wellbeing intervention among patients with heart disease who were randomly selected from patients referring to Saheb al-Zaman Hospital in Shahreza. Participants were then randomized to the psychological wellbeing intervention or the control condition using concealed cards with group assignment listed that were only accessed by study staff following completion of baseline assessments.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants were blind about the grouping and assignments. Also group assignment listed were only accessed by study staff following completion of baseline assessments. Statistical analysts were also blind to the groups.
Placebo
Used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
islamic azad university khorasgan branch
Street address
University Blvd, Arghavanieh, The East Jey St., Isfahan
City
Isfahan
Province
Isfehan
Postal code
۸۶۱۷۷۴۳۱۱۱
Approval date
2017-12-13, 1396/09/22
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.077
Health conditions studied
1
Description of health condition studied
Cardiac patients with definite diagnosis of coronary artery disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
The primary outcome is the psychological well-being and feasibility of the intervention
Timepoint
Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention).
Method of measurement
Instrument included Ryff psychological well-being questionnaire (1993).
Secondary outcomes
1
Description
Depression, Optimism (Life Orientation), and positive and negative affects
Timepoint
Measurements were performed at pre-test (Before the intervention), post-test (9 weeks after the intervention) and follow-up (15 weeks after the intervention).
Method of measurement
Instruments included Beck Depression Inventory (1996), Life Orientation Test (LOT, 1985), and positive and negative affects questionnaire (PANAS 1989).
Intervention groups
1
Description
Intervention group: Intervention group received well-being therapy based on Ryff psychological well-being (2014) during 8 sessions (weekly, 90 minutes, for 8 weeks).
Category
Behavior
2
Description
Control group: Attention control group received usual medical education during 8 sessions (weekly, 90 minutes, for 8 weeks).
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Sahib al-Zaman Hospital
Full name of responsible person
Leila Eshaghi
Street address
Sahib Al Zaman Hospital - Sahib Al Zaman St. - Shahreza city
City
Shahreza
Province
Isfehan
Postal code
۸۶۱۷۷۴۳۱۱۱
Phone
+98 31 5322 3000
Email
eshaghi1453@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Nurbakhsh
Street address
2nd Kilometer of Mobarakeh Road-Boroujen -
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871898555
Phone
+98 38 3422 3812
Email
info@iauboroujen.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
1
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
Leila Eshaghi
Position
M.A. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd Kilometer of Mobarakeh Road- Boroujen
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871898555
Phone
+98 38 3422 3812
Email
eshaghi1453@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Gholam Reza Nikrahan
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
2nd Kilometer of Mobarakeh Road-Boroujen
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871898555
Phone
+98 38 3422 3812
Email
rezanikrahan@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Leila Eshaghi
Position
M.A. Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
2nd Kilometer of Mobarakeh Road- Boroujen
City
Boroujen
Province
Chahar-Mahal-va-Bakhtiari
Postal code
8871898555
Phone
+98 38 3422 9220
Email
eshaghi1453@gmail.com
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 potential data can be shared after being "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
برای همه قابل دسترس خواهد بود
Under which criteria data/document could be used
شرط خاصی وجود نخواهد داشت
From where data/document is obtainable
لیلا اسحاقی
eshaghi1453@gmail.com
What processes are involved for a request to access data/document
فرایند خاصی وجود نخواهد داشت صرفا از طریق ارسال ایمیل پاسخگو خواهیم بود