Effectiveness of cognitive-behavioral therapy with treatment based on compassion and Intellectual-Motor Exercises on elderly,s plasma lipoproteins, executive functions, psychological syndrome, and sleep quality
Evaluation of the effectiveness of cognitive-behavioral therapy with treatment based on compassion and Intellectual-Motor Exercises on elderly,s plasma lipoproteins, executive functions, psychological syndrome, and sleep quality
Design
An intervention design
Individuals are randomly assigned to four groups based on matching scores and assigned to each code. They are randomly assigned to one of three experimental groups and one control group to form three experimental groups and one control group. There are 15 people in each group, and for each person in that group, there will be one person in each of the other 3 groups.
Settings and conduct
the study will be in Neshat Elderly day care center in Mashhad. intervention and control groups with non-blinding random assignment of selection and training will be applied.
Participants/Inclusion and exclusion criteria
participants should have at least 60 years old ،
no major cognitive deficits or Alzheimer,s disease
willingness to participate in study
The number of points required for the cognitive ability screening tests .
Having any major psychological disorder
The lack of high cholesterol ( LDL outside 130 and 100 ) ( HDL for women less than 60 and for men less than 40 )
Intervention groups
Intervention group 1, cognitive-behavioral therapy combined with compassion-based therapy and cognitive-motor activities. Members first receive cognitive-behavioral therapy and then compassion-based therapy for both cognitive-behavioral activities, including sudoku activities, along with simple motor activities such as lifting the arms and moving the legs once a week.
Intervention group 2, behavioral therapy combined with compassion-based therapy
Effectiveness of cognitive-behavioral therapy with treatment based on compassion and Intellectual-Motor Exercises on elderly,s plasma lipoproteins, executive functions, psychological syndrome, and sleep quality
Public title
Effectiveness of cognitive-behavioral therapy with treatment based on compassion and Intellectual-Motor Exercises on elderly,s plasma lipoproteins, executive functions, psychological syndrome, and sleep quality
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
participants should have at least 60 years old ،
no major cognitive deficits or Alzheimer,s disease
willingness to participate in study
Exclusion criteria:
The number of points required for the cognitive ability screening tests .
Having any major psychological disorder
The lack of high cholesterol ( for LDL outside 130 and 100 ) and ( HDL for women less than 60 and for men less than 40 )
Age
From 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Selected individuals are tested for research based on the test scores scores . then all study individuals are performed randomly in four peer groups . Then everybody in the group finds a code of interest. As from the no 1 to no 15 in one group, from the number 16 to No 30 hn another group ,from no 31 to no 45 in next group and from no 46 to no 60 in last group. Finally , each group was assigned randomly in one of the three experimental groups ( the experimental group no1 ; the experimental group no 2, the experimental group no 3) and one control group ( group no 4 ) . in such a way that there are hundreds of thousands of people per person in the screening test scores of the same group in the other three groups .
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 Birjand university of medical sciences.
Street address
Birjand University of Medical Sciences. Ghafari st
City
Birjand
Province
Razavi Khorasan
Postal code
09717853577
Approval date
2019-05-01, 1398/02/11
Ethics committee reference number
IR.BUMS.REC.1398.003
Health conditions studied
1
Description of health condition studied
psychological syndrome
ICD-10 code
ICD-10 code description
2
Description of health condition studied
high cholesterol level
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
plasma lipoproteins,
Timepoint
one week before the intervention started and one week after the end of interventions .
Method of measurement
by blood test
2
Description
executive functions,
Timepoint
one week before the intervention started and one week after the end of interventions .
Method of measurement
Behavior Rating Inventory of Executive Function (BRIEF)
3
Description
psychological syndrome(anxiety and depression)
Timepoint
one week before the intervention started and one week after the end of interventions .
Method of measurement
General Anxiety Inventory ( GAI ) and General Depression Scale for older persons
4
Description
sleep quality
Timepoint
one week before the intervention started and one week after the end of interventions .
Method of measurement
Pittsburgh Sleep Quality Index ( psqi )
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group : They first receive cognitive - behavioral training , and on compassion Focused Therapy. during the ten - minute session , twice in the week with, behavioral cognitive functions include activities such as puzzels , and simple activities such as lifting the hands and legs per week
Category
N/A
2
Description
Intervention group: Group B :Cognitive-Behavioral Therapy with Compassion Focused Therapy. they received cognitive - behavioral therapy and then continuing the treatment based on compassion in two sessions per week , twice per week
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Nesht day care of elderly center
Full name of responsible person
Mrs Hamideh Safaryan
Street address
No. 255, Next to the Kalantari4, Shahid Kalantari Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9176983373
Phone
+98 51 3878 1198
Email
neshatdaycare@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Fatemeh Shahabi Zadeh
Street address
Azad University of Birjand, End of Ghafari Aven
City
Birjand
Province
South Khorasan
Postal code
9717846783
Phone
+98 56 3131 0220
Email
aliabadi@iaubir.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Anahita Kashmari
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.88, First of Mina St, 10.3 of Baharestan,Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9187874136
Phone
+98 51 3761 5377
Email
Anahita.kashmari1347@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anahita Kashmari
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.88, First of Mina St,10.3 of Baharestan, Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9187874136
Phone
+98 51 3761 5377
Email
Anahita.kashmari1347@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Anahita Kashmari
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No.88, First of Mina St, 10.3 of Baharestan, Sajjad Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9187874136
Phone
+98 51 3761 5377
Email
Anahita.Kashmari1347@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD