Comparative study of the effectiveness of Cognitive-Behavioral Therapy and usual care on depression and dysfunctional attitudes in patients with cardiovascular diseases after coronary artery bypass graft surgery: a randomized clinical trial
The main objective of the study was to determine the effectiveness of cognitive-behavioral therapy on depressive symptoms and dysfunctional attitudes in patients after CABG surgery
Design
The study used a randomized clinical trial design comparing a Cognitive Behavioral Therapy based on problem solving model with usual care group (control group). Participants were selected based on available sampling and randomly allocated to groups using random numbers table.
Settings and conduct
This study is a randomized clinical trial in which two-group pretest–posttest design will be used. Instruments used for data gathering in this study is Beck Depression Inventory and Dysfunctional Attitude Scale (DAS).
Location of study: Shadeed Modarres Hospital.
Number of patients in the intervention group: 22.
Number of patients in the control group: 22.
Participants/Inclusion and exclusion criteria
Inclusion criteria: meeting DSM-5 diagnostic criteria for depression associated with another medical condition; Under 70 years old; Education: At least diploma; Fluent in Persian language; Score of the Beck Depression Inventory: more than 10; Score of the Dysfunctional Attitude Scale (DAS): more than 26. Non-inclusion criteria: Taking psychiatric drugs during the last 6 months; Taking current psychiatric drugs; Patients with psychiatric disorder who need urgent treatment; Participate in other treatments, simultaneously.
Intervention groups
Treatment group: Cognitive Behavioral Therapy based on problem solving model. Patients in intervention group received Cognitive Behavioral Therapy individually through six 1-hour sessions. The content of the sessions were problem-solving skills, pleasurable activity scheduling and homework during the period of 35-date.
Control group: control group only received two usual educational sessions.
Main outcome variables
Depression; Dysfunctional Attitudes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20170808035568N2
Registration date:2019-03-05, 1397/12/14
Registration timing:retrospective
Last update:2019-03-05, 1397/12/14
Update count:0
Registration date
2019-03-05, 1397/12/14
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
Expected recruitment start date
2018-09-27, 1397/07/05
Expected recruitment end date
2018-12-01, 1397/09/10
Actual recruitment start date
2018-09-11, 1397/06/20
Actual recruitment end date
2018-11-06, 1397/08/15
Trial completion date
2018-11-06, 1397/08/15
Scientific title
Comparative study of the effectiveness of Cognitive-Behavioral Therapy and usual care on depression and dysfunctional attitudes in patients with cardiovascular diseases after coronary artery bypass graft surgery: a randomized clinical trial
Public title
Effectiveness of Cognitive-Behavioral Therapy on Depression and Dysfunctional attitudes in patients with Cardiovascular diseases
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having DSM-5 diagnostic criteria for depression associated with another medical condition
Under 70 years old
Education: At least diploma
Fluent in Persian language
Score of the Beck Depression Inventory: more than 10
Score of the Dysfunctional Attitude Scale (DAS): more than 26
Exclusion criteria:
Taking psychiatric drugs during the last 6 months.
Taking current psychiatric drugs
Patients with psychiatric disorder who need urgent treatment
Participate in other treatments, simultaneously
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:
65
Actual sample size reached:
44
Randomization (investigator's opinion)
Randomized
Randomization description
Sample selection were performed based on available sampling and participants were randomly allocated to groups using random numbers table.
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 Shahid Beheshti University of Medical Science
Street address
Medical College, Shahid Beheshti University of Medical Sciences, Arabi street, Daneshjoo bouleward, Evin
City
Tehran
Province
Tehran
Postal code
89
Approval date
2015-06-28, 1394/04/07
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
Ischemic heart diseases
Primary outcomes
1
Description
Depression score
Timepoint
Pre-intervention, During the intervention and Post-intervention
Method of measurement
Beck Depression Inventory
Secondary outcomes
1
Description
Dysfunctional Attitudes
Timepoint
Pre-intervention, During the intervention and Post-intervention
Method of measurement
Dysfunctional Attitudes Scale-26
Intervention groups
1
Description
Intervention group: Cognitive-Behavioral Therapy program based on problem-solving model. Number of sessions: 8 individual 90 minute sessions, three days a week. Study protocol: Problem solving model, adapted from Robert L. Leahy.
Category
Treatment - Other
2
Description
Control group: participants in the usual care group received two educational sessions on cardiovascular disease. 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
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Modarres Hospital
Full name of responsible person
Dr. Mohammad Masoud Majidi Tehrani
Street address
Saadat Abad Street - Yadegare Imam Highway
City
Tehran
Province
Tehran
Postal code
1998734383
Phone
+98 21 2207 4087
Fax
+98 21 2207 4101
Email
modarres@sbmu.ac.ir
Web page address
https://modarres.sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Seyed Ali Ziaei
Street address
Medical College, Shahid Beheshti University of Medical Sciences, Arabi street, Daneshjoo bouleward, Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
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 Sciences
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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Hajitabar Firouzjaei
Position
MSc
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Next to Ayatollah Taleghani hospital, Shahid Arabi street, Yaman street, Shahid Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Hajitabar Firouzjaei
Position
MSc
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Medical College, Shahid Beheshti University of Medical Sciences, Arabi street, Daneshjoo bouleward, Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Nima Hajitabar Firoujaei
Position
MSc
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Medical College, Shahid Beheshti University of Medical Sciences, Arabi street, Daneshjoo bouleward, Evin
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 23871
Email
info@sbmu.ac.ir
Web page address
https://www.sbmu.ac.ir/
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available