The effectiveness of Cognitive Behavioral Therapy on symptoms of depression, dysfunctional attitudes and level of social support in patients with cardiovascular disease
The main objective of the study was to determine the effectiveness of cognitive-behavioral therapy on depressive symptoms, dysfunctional attitudes and social support in cardiovascular patients.
Present research is basic-applied and is experimental methodologically; Plan: Pretest and Post-test with control group.
After the preliminary screening of 167 patients who has been referred to Hospital, 24 people of eligible patients for this study were selected. In the end: 21 people of the patients were selected. 10 sample for treatment group and 11 sample for control group.
Inclusion criteria are: sufficient knowledge of the Persian language, meeting the diagnostic criteria for depression due to other medical condition according to DSM-5, age: under 70 years, the minimum official education: diploma, a minimum score of 10 on the Beck Depression Inventory, a minimum score of 26 on the Dysfunctional Attitudes Scale-26. Exclusion criteria are: already receiving psychotherapy for mental health problems, taking psychiatric drugs during the last 6 months, the presence of severe depressive symptoms (indicated by a score above 40 on the items of the Beck Depression Inventory-II; BDI-II).
Intervention: Problem Solving Therapy (PST) on based Robert Leahy protocol.
Time: 50 days.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017080835568N1
Registration date:2017-08-13, 1396/05/22
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-08-13, 1396/05/22
Registrant information
Name
Nima Hajitabar Firouzjaei
Name of organization / entity
Shahid Beheshti University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 6670 5780
Email address
hajitabarnima@gmail.com
Recruitment status
Recruitment complete
Funding source
Investigator
Expected recruitment start date
2015-05-22, 1394/03/01
Expected recruitment end date
2015-08-23, 1394/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Cognitive Behavioral Therapy on symptoms of depression, dysfunctional attitudes and level of social support in patients with cardiovascular disease
Public title
Cognitive-Behavioral Therapy for Cardiovacular Disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria are: sufficient knowledge of the Persian language, meeting the diagnostic criteria for depression due to other medical condition according to DSM-5, age: under 70 years, the minimum official education: diploma, a minimum score of 10 on the Beck Depression Inventory, a minimum score of 26 on the Dysfunctional Attitudes Scale-26. Exclusion criteria are: already receiving psychotherapy for mental health problems, taking psychiatric drugs during the last 6 months, the presence of severe depressive symptoms (indicated by a score above 40 on the items of the Beck Depression Inventory-II; BDI-II).
Age
From 25 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
21
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Beheshti University of Medical Science
Street address
Teharan - Evin - Student bouleward- Arabi street- Medical College, Shahid Beheshti University of Medical Science.
City
Tehran
Postal code
89
Approval date
2015-05-05, 1394/02/15
Ethics committee reference number
ir.sbmu.msp.rec.1394.47
Health conditions studied
1
Description of health condition studied
Cardiovascular Disease
ICD-10 code
I20-I25 ,
ICD-10 code description
Ischaemic heart diseases , Other forms of heart disease
Primary outcomes
1
Description
Depression
Timepoint
Pre-intervention, During the intervention and Post-intervention.
Method of measurement
BDI-II
Secondary outcomes
1
Description
Dysfunctional Attitudes
Timepoint
Pre-intervention, During the intervention and Post-intervention.
Method of measurement
Dysfunctional Attitudes Scale-26
2
Description
Social Support
Timepoint
Pre-intervention, During the intervention and Post-intervention.
Method of measurement
Multidimensional Scale of Perceived Social Support Scale
Intervention groups
1
Description
The study used a randomized controlled design comparing a Problem Solving Therapy with usual care group (control group). The study protocol has been approved by the Medical Ethics Committee of the Medicine Faculty of Shahid Beheshti University of Medical Science. All patients in the treatment group receive basic information on the use of the program.
Category
Treatment - Other
2
Description
Participants in the usual care condition received two educational sessions on cardiovascular disease and a depression brochure. Educational sessions included the following topics:
1) Medical education about heart disease and CABG surgery. 2) General education about health care after heart Bypass surgery. 3) Having a good Diet Program. 4) Having a daily walking program. The mentioned educations has been under the supervision of cardiologist.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Nima Hajitabatr Firouzjaei
Street address
Teharan - Evin - Student bouleward- Arabi street- Medical College, Shahid Beheshti University of Medical Science.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Science
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
Shahid Beheshti University of Medical Science
Full name of responsible person
Nima Hajitabar Firouzjaei
Position
MSc, Clinical Psychology
Other areas of specialty/work
Street address
Teharan - Evin - Student bouleward- Arabi street- Medical College, Shahid Beheshti University of Medical Science.
City
Tehran
Postal code
Phone
+98 21 6670 5780
Fax
Email
nimahajitabar@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Nima Hajitabar Firouzjaei
Position
MSc, Clinical Psychology
Other areas of specialty/work
Street address
Teharan - Evin - Student bouleward- Arabi street- Medical College, Shahid Beheshti University of Medical Science.
City
Tehran
Postal code
98
Phone
+98 21 6670 5780
Fax
Email
nimahajitabar@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Science
Full name of responsible person
Nima Hajitabar Firouzjaei
Position
MSc Clinical Psychology
Other areas of specialty/work
Street address
Teharan - Evin - Student bouleward- Arabi street- Medical College, Shahid Beheshti University of Medical Science.
City
Tehran
Postal code
98
Phone
+98 21 6670 5780
Fax
Email
nimahajitabar@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)