Study of the Effect of Nurse-Led Cognitive-Behavioral Therapy (CBT) on Elder Abuse and Guilt feeling among Family Caregivers of Persons with Alzheimer’s Disease
Determination of the Effect of Nurse-Led Cognitive-Behavioral Therapy (CBT) on Elder Abuse and Guilt feeling among Family Caregivers of Persons with Alzheimer’s Disease
Design
Randomized Clinical trials with control group, with parallel groups, without blindness,
Settings and conduct
The choice of 70 family caregivers of Alzheimer's patients referred to the Alzheimer's Association and divided into two groups: control and intervention with random allocation and in the intervention group, cognitive-behavioral intervention in the form of group meetings with a maximum of 15 caregivers with face-to-face method in 12-10 sessions will be held at the Alzheimer's Association with 2 sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
The willingness to participate in research
Caregivers that care the people with Alzheimer's who are over than 65 years old
Alzheimer's family caregivers
Having reading and writing skills
No diagnosed psychological disorders
Age over than 18 years old
Give score 2 and above for MCTS
Exclusion Criteria
Unwillingness to continue presence in the research
Death of a person with Alzheimer disease
Change caregivers or give person with Alzheimer disease to care centers
Not attending meetings (2 consecutive or 3 alternate session)
Intervention groups
Intervention group: Cognitive-behavioral intervention in the form of a group of 15 participants with face-to-face method in 12-10 sessions
Control group: receive Alzheimer's Association routine
Main outcome variables
abuse؛ guilt feeling
General information
Reason for update
Acronym
CBT
IRCT registration information
IRCT registration number:IRCT20190413043262N1
Registration date:2019-05-09, 1398/02/19
Registration timing:registered_while_recruiting
Last update:2019-05-09, 1398/02/19
Update count:0
Registration date
2019-05-09, 1398/02/19
Registrant information
Name
Elham Navab
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6105 4412
Email address
e-navab@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-01-21, 1397/11/01
Expected recruitment end date
2019-05-22, 1398/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the Effect of Nurse-Led Cognitive-Behavioral Therapy (CBT) on Elder Abuse and Guilt feeling among Family Caregivers of Persons with Alzheimer’s Disease
Public title
The Effect of Nurse-Led Cognitive-Behavioral Therapy (CBT) on Elder Abuse and Guilt feeling among Family Caregivers of Persons with Alzheimer’s Disease
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Age over than 18 years old
Having reading and writing skills
The willingness to participate in research
Alzheimer's family caregivers
No diagnosed psychological disorders
Give score 2 and above for MCTS
Caregivers that care the people with Alzheimer's who are over than 65 years old
Exclusion criteria:
Diagnosis of psychiatric and cognitive conditions
Unwillingness to continue presence in the research
Death of a person with Alzheimer disease
Change caregivers or give person with Alzheimer disease to care centers
Not attending meetings (2 consecutive or 3 alternate session)
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
70
Randomization (investigator's opinion)
Randomized
Randomization description
The samples were selected by continuous sampling and the patients will be placed in two groups of control and case by Block Balanced Randomization (BBR). Using the free web site http://www.randomization.com/, the assignment sequence will take place. In such a way that the number of subjects in each block is set to 5 and for the control group letter A and for the case group, the letter B will be considered and finally by confirming the creation of the sequence of allocation (Randomization Sequence) in the system for 14 blocks , The assignment sequence will be created for 70 examples by combining the letters A and B. Finally, the cards containing the blocks will be placed inside the standard envelope, and as a result, allocation concealment will be considered and observed. Based on qualified samples, an Envelope Shuffling Envelope will be removed by the researcher accidentally. Finally, the random allocation method is determined by the research samples.
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 Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Tehran, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2018-11-06, 1397/08/15
Ethics committee reference number
IR.TUMS.FNM.REC.1397.148
Health conditions studied
1
Description of health condition studied
Abuse
ICD-10 code
T74.1
ICD-10 code description
Physical abuse, confirmed
2
Description of health condition studied
abuse
ICD-10 code
T74.31
ICD-10 code description
Adult psychological abuse, confirmed
3
Description of health condition studied
guilt feeling
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Abuse
Timepoint
Before the intervention and after the end of session 6 and after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Modified Conflict Tactics Scale
2
Description
Guilt feeling
Timepoint
Before the intervention and after the end of session 6 and after the end of the intervention and 3 months after the end of the intervention
Method of measurement
Caregiver Guilt Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Nurse-Led Cognitive-Behavioral Therapy will be held nurse-researcher in the form of face-to-face group meetings in 12-10 The meeting will be held at the Alzheimer's Association with 2 sessions per week.
Category
Behavior
2
Description
Control group: No intervention
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Alzheimer Association
Full name of responsible person
Masoumeh Salehi
Street address
Tehran, Ekbatan, between phase 1 and 2, Basij Square, the beginning of the exit to the northern side, next to the municipality of District 6
City
Tehran
Province
Tehran
Postal code
۱۳۹۶۹۵۶۱۴۴
Phone
+98 21 4463 3555
Fax
+98 21 4465 1122
Email
alzheimer.iran@yahoo.com
Web page address
http://iranalz.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Mohammadali Sahraian
Street address
Keshavarz Blvd., Ghods St., Central Organization of the University, 6th floor of Research and Technology Department
City
Tehran
Province
Tehran
Postal code
1417653761
Phone
+98 21 8163 3698
Email
vcr@sina.tums.ac.ir
Web page address
http://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Afsaneh Pourmillamirza
Position
Master student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
a.pourmollamirza@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Elham NAVAB
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq.
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
e_navab100@hotmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Afsaneh Pourmollamirza
Position
Master student of geriatric nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Nosrat st. Tohid sq. Tehran I.IRAN
City
Tehran
Province
Tehran
Postal code
1419733171
Phone
+98 21 6105 4000
Email
a.pourmollamirza@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
Not applicable
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