investigate the effect of coping skills training on depression and adherence to treatment in patients with heart failure referred to Shahid Rajaei hospital
Determining the effect of coping skills training on depression and adherence to treatment in patients with heart failure.
Design
This randomized clinical trial study will be conducted with two control and intervention groups, with parallel groups, and single-blind strain on 72 patients with heart failure. A table of random numbers will be used for randomization.
Settings and conduct
This study will be conducted on 72 patients referred to Shahid Rajaee Hospital. In the intervention group, coping skills training will be taught. The control group will not receive any training. After the completion of the intervention, the depression and adherence to the treatment of the patients will be measured. Patients, caregivers, clinical outcome assessors, and data analysts will be blind to the groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria include a definite diagnosis of Heart failure, not participating in the same training courses simultaneously, informed consent to participate in the study, and no cognitive-behavioral disease. Exclusion criteria is including having a history of similar training programs.
Intervention groups
In addition to routine hospital care, in the intervention group, coping skills will teach in 12 (20-minute) sessions over the phone. Routine hospital care will be conducted for the control group and no other training will be given.
Main outcome variables
Depression and adherence to the treatment
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221017056217N1
Registration date:2022-12-17, 1401/09/26
Registration timing:prospective
Last update:2022-12-17, 1401/09/26
Update count:0
Registration date
2022-12-17, 1401/09/26
Registrant information
Name
Sepideh Taghavi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2116
Email address
sepideh1349@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-12-22, 1401/10/01
Expected recruitment end date
2023-01-21, 1401/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
investigate the effect of coping skills training on depression and adherence to treatment in patients with heart failure referred to Shahid Rajaei hospital
Public title
The effect of coping skills training on depression and adherence to treatment of heart patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of Heart failure
Not participating in the other training courses at the same time
Informed consent to participate in the study
No cognitive-behavioral disease
Exclusion criteria:
History of having a similar training program
Age
From 16 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly selected based on the included criteria and allocated into two intervention and control groups of 35 people using a lottery. After selecting each patient, the patient's name will be written in a sealed envelope, and someone other than the researcher will be asked to choose whether to be assigned to the intervention or control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, randomization will be done by the researcher, and the other people, including clinical caregivers, outcome evaluators, and data analysts are blind to the allocation of samples to control and intervention groups. Thus, after the intervention by the researcher, the questionnaires will be completed by the assistant of the researcher who is blind to the type of sample group. The data also will be analyzed by a person who is blind to the type of sample group.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Heart and Vascular Training, Research, and Treatment Center.
Street address
Shahid Rajaei Cardiovascular Training, Research, and Treatment Center - Next to Mellat Park- Wali Asr St - Tehran - Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2022-02-23, 1400/12/04
Ethics committee reference number
IR.RHC.REC.1400.119
Health conditions studied
1
Description of health condition studied
Heart failure
ICD-10 code
I50
ICD-10 code description
Heart failure
2
Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Major depressive disorder, single episode
Primary outcomes
1
Description
Depression score in Back questionnaire
Timepoint
Before and immediately after the end of the intervention
Method of measurement
Back Depression questionnaire
Secondary outcomes
1
Description
Adherence to treatment score In the Modanloo adherence to treatment questionnaire
Timepoint
Before and immediately after the end of the intervention
Method of measurement
Modanloo adherence to treatment questionnaire
Intervention groups
1
Description
Intervention group: Coping skills training will include relaxation methods, mental imagery, an adaptation mechanism, a problem-solving method, and anger control in the form of telephone conversations and mutual interaction. This intervention will be taught in 12 sessions of 20 minutes during one month.
Category
Treatment - Other
2
Description
Control group: Will not receive any intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaee Cardiovascular Training, Research and Medical Center
Full name of responsible person
Sepideh Taghavi
Street address
Rajaee hospital, next to the Mellat Park, Vali Asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sepideh1349@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Saeid Hosseini
Street address
Rajaee hospital, next to the Mellat Park, Vali Asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
hosseini@rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical and Research Center
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
Iran University of Medical Sciences
Full name of responsible person
Sepideh Taghavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Rajaee hospital, next to the Mellat Park, Vali Asr Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sepideh1349@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
sepideh Taghavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Rajaee hospital, next to the Mellat Park, Vali Asr street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sepideh1349@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sepideh Taghavi
Position
Associate professor
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Rajaee hospital, next to the Mellat Park, Vali Asr street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sepideh1349@yahoo.com
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
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
Undecided - It is not yet known if there will be 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