The study of the effectiveness of Seligman, Fordyce and Lyubomirsky happiness training programs on inflammatory markers and mental health in coronary artery patients
The aim of this study is examining and comparing the effectiveness of three happiness interventions on cortisol awakening response, inflammatory markers and mental health variables in coronary patients. Inclusion criteria include of undergoing CABG or PCI and exclusion criteria include of antidepressant usage or being under psychotherapy and/or anti-inflammatory or immunologic medication usage.
Methods: The target population is coronary patients referring to medical centers in Isfahan. In present study 69 CAD patients will assign to three HTPs groups, including Seligman, Lyubomirsky and Fordyce groups and a control group. The control group will not receive training program. Assessments will include cortisol awakening response, plasma levels of C-reactive protein, IL-1, IL-6, and depression, happiness, life satisfaction and hope at pretest, the end of the week 6th of intervention, and 15 weeks after starting of the programs in follow up phase.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014010516081N1
Registration date:2014-02-12, 1392/11/23
Registration timing:retrospective
Last update:
Update count:0
Registration date
2014-02-12, 1392/11/23
Registrant information
Name
Gholam Reza Nikrahan
Name of organization / entity
The University of Isfahan
Country
Iran (Islamic Republic of)
Phone
+98 31 1444 2953
Email address
nikrahan@edu.ui.ac.ir
Recruitment status
Recruitment complete
Funding source
The University of Isfahan
Expected recruitment start date
2011-12-22, 1390/10/01
Expected recruitment end date
2012-04-20, 1391/02/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The study of the effectiveness of Seligman, Fordyce and Lyubomirsky happiness training programs on inflammatory markers and mental health in coronary artery patients
Public title
The study of the effectiveness of happiness interventions on coronary artery patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: undergoing CABG or PCI
Exclusion criteria : medical condition limiting ability to participate in the study; unwillingness to participate in all stages of study; antidepressant usage or being under psychotherapy; anti-inflammatory or immunologic medication usage
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
69
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The University of Isfahan
Street address
The University of Isfahan- hezar jarib st.-
City
Isfahan
Postal code
Approval date
2011-07-06, 1390/04/15
Ethics committee reference number
UI1390/36749
Health conditions studied
1
Description of health condition studied
Coronary artery disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
CRP
Timepoint
Pretest- posttest-followup
Method of measurement
CRP Kit
2
Description
IL-1
Timepoint
Pretest- posttest-followup
Method of measurement
IL-1 Kit
3
Description
IL-6
Timepoint
Pretest- posttest-followup
Method of measurement
IL-6 Kit
4
Description
salivary cortisol
Timepoint
Pretest- posttest-followup
Method of measurement
cortisol kit
5
Description
Happiness
Timepoint
Pretest- posttest-followup
Method of measurement
Oxford quastionnaire
6
Description
Depression
Timepoint
Pretest- posttest-followup
Method of measurement
BDI-II
7
Description
Life satisfaction
Timepoint
Pretest- posttest-followup
Method of measurement
DINER SWL SCALE
8
Description
Hope
Timepoint
Pretest- posttest-followup
Method of measurement
Snyder hope scale
Secondary outcomes
empty
Intervention groups
1
Description
The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts.
Fordyce's HTP: W1: 1-keep busy and be more active 2- Spend more time socializing 3- Close relationships. W2: 1-Be productive 2-Get better organized and plan things out. W3:1-Stop worrying 2-Lower your expectations and aspirations. W4: 1-Develop positive, optimistic thinking 2-Become present oriented. W5: 1-Be yourself 2-Work on a healthy personality 3-Develop an outgoing, social personality. W6: 1-Eliminate negative feelings and problems 2-Put happiness as your most important priority.
Category
Other
2
Description
The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts.
Lyubomirsky's HTP : W1: 1-Acting like a happy person 2-Savoring life's Joys 3-Practicing acts of kindness. W2: 1-Nurturing social relationships 2-physical activity. W3: 1-Cultivating optimism 2-Expressing gratitude. W4: 1-Avoiding overthinking and social comparison 2-Developing strategies for coping. W5: 1- Learning to forgive 2-Practicing religion and spirituality. W6: 1-Increasing flow experiences 2-Committing to your goals 3-Meditation.
Category
Other
3
Description
The happiness training programs (HTP) will plan in six sessions, each lasting 1.5 hours, on a weekly basis for 1.5 months, with weekly exercises. During each session, happiness trainer will provide the intervention manual, will present happiness strategies and techniques, and discuss the rationale for the happiness exercises and their positive impacts.
Seligman's HTP: Week 1 (W1): 1-Free yourself of imprisoning determinism 2- contentment 3- Forgiving and forgetting. W2: 1-Enhancing the pleasures 2-gratification. W3: 1-Increasing optimism 2- Increasing hope. W4: 1-Your signature strengths. W5: 1 Deploy your signature strengths 2-Your partner’s strengths. W6: The meaningful life.
Category
Other
4
Description
The control group will not receive any training program and will be in waiting list until the end of the study and then will receive the most effective intervention among HTPs.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
The Iran Zamin cardiac rehabilitation center
Full name of responsible person
Saeedeh Hashemi
Street address
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
The University of Isfahan
Full name of responsible person
Dr. Asgari Karim
Street address
The University of Isfahan- Hezarjarib st.
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
The University of Isfahan
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
The university of Isfahan
Full name of responsible person
Gholamreza Nikrahan
Position
Ph.D student
Other areas of specialty/work
Street address
The university of isfahan- Hezarjarib st.
City
Isfahan
Postal code
Phone
+98 31 1444 2953
Fax
Email
nikrahan@edu.ui.ac.ir / rezanikrahan@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Gholamreza Nikrahan
Position
Ph.D student
Other areas of specialty/work
Street address
The University of Isfahan, Hzarjarib St., Isfahan
City
Isfahan
Postal code
Phone
+98 31 1444 2953
Fax
Email
nikrahan@edu.ui.ac.ir and rezanikrahan@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
The University of Isfahan
Full name of responsible person
Gholamreza Nikrahan
Position
Other areas of specialty/work
Street address
The University of Isfahan, Hzarjarib St., Isfahan, Iran
City
Isfahan
Postal code
Phone
+98 31 1444 2953
Fax
Email
nikrahan@edu.ui.ac.ir and rezanikrahan@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)