Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on grief, psychological distress, symptoms related to sleep disturbances, coping strategies and quality of life in caregivers of cancer patients
Comparing the effectiveness of cognitive behavioral therapy and emotional therapy on bereavement, psychological disturbances, symptoms related to sleep disturbances, coping strategies and quality of life in caregivers of cancer patients
Design
First, through the Maxa Cancer Control Charitable Foundation located in
The city of Mashhad will obtain the necessary permission for cooperation and then help for referral and introduction
Participants (families of cancer patients), this foundation will make the necessary arrangements
Settings and conduct
The implementation method in this research will be as follows, first through the Maxa Cancer Control Charitable Foundation located in
The city of Mashhad will obtain the necessary permission for cooperation and then help for referral and introduction
Participants (families of cancer patients), this foundation will make the necessary arrangements
Participants/Inclusion and exclusion criteria
Age above 18 years
- Having a minimum education degree
- Having a caring role for a person with cancer
-Caring for patients who have been diagnosed with cancer for at least a year
- Suffering from severe cognitive and personality disorders and taking psychiatric drugs
- Drug abuse
- Simultaneous participation in other psychological interventions
Intervention groups
45 samples and sampling methods will be available.
There are 15 people in each experimental group and 15 people in the control group
Main outcome variables
Although in the treatment of disorders
psychological and behavioral problems, both cognitive behavioral approaches and emotion-based therapy are used, repetition
And the comparison of these two approaches in terms of examining the effectiveness of cognitive techniques against emotional as one of
The reasons raised in the necessity of conducting this research will be considered
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230910059391N1
Registration date:2024-03-01, 1402/12/11
Registration timing:prospective
Last update:2024-03-01, 1402/12/11
Update count:0
Registration date
2024-03-01, 1402/12/11
Registrant information
Name
Iran Habibi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3882 9543
Email address
arezoo.habibi051@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-08, 1403/01/20
Expected recruitment end date
2024-06-19, 1403/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on grief, psychological distress, symptoms related to sleep disturbances, coping strategies and quality of life in caregivers of cancer patients
Public title
Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on grief, psychological distress, symptoms related to sleep disturbances, coping strategies and quality of life in caregivers of cancer patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years
Having at least a diploma
Having a caregiver role for a person with cancer (usually as a family member or close friend)
Caring for patients who have been diagnosed with cancer for at least one year
The cancer must be of an advanced type as diagnosed by the doctor
Informed consent to receive medical services
Regular participation in therapy sessions (cognitive behavioral therapy and emotion-oriented therapy) according to protocol therapy
Exclusion criteria:
Having severe cognitive and personality disorders and taking psychiatric drugs
Drug abuse
Simultaneous participation in other psychological interventions
Age
From 18 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
45
Randomization (investigator's opinion)
Randomized
Randomization description
The method of implementation in this research will be as follows: First, permission will be obtained through the Maxa Cancer Control Charitable Foundation located in Mashhad, and then in order to help refer and introduce the participants (families of cancer patients), from This foundation will make the necessary arrangements. In the following, 45 people will be selected from the mentioned statistical population using the available sampling method and will be assigned to three groups of 15 people in the test and the control group using random replacement. Next, necessary information will be given on how to implement the protocol and efforts will be made to establish a good relationship with mutual cooperation. After the pre-test, separate test groups will participate in cognitive-behavioral therapy and emotion-oriented therapy sessions, and then the post-test and 2-month follow-up will be performed
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
National system of ethics in biomedical research
Street address
Khorasan Razavi Province, Neishabur, Research Blvd., Islamic Azad University Complex, Neishabur branch
City
neyshabour
Province
Razavi Khorasan
Postal code
۹۳۱۹۹۷۵۸۵۳
Approval date
2024-02-14, 1402/11/25
Ethics committee reference number
IR.IAU.NEYSHABUR.REC.1402.032
Health conditions studied
1
Description of health condition studied
grief
ICD-10 code
F43.8
ICD-10 code description
Other reactions to severe stress
2
Description of health condition studied
psychological distress
ICD-10 code
F68.0
ICD-10 code description
Elaboration of physical symptoms for psychological reasons
3
Description of health condition studied
symptoms related to sleep disturbances
ICD-10 code
G47.2
ICD-10 code description
Disorders of the sleep-wake schedule / Delayed sleep phase syndrome / Irregular sleep-wake pattern
4
Description of health condition studied
coping strategies
ICD-10 code
F43.9
ICD-10 code description
Reaction to severe stress, unspecified
5
Description of health condition studied
quality of life
ICD-10 code
Z62.8
ICD-10 code description
Other specified problems related to upbringing
Primary outcomes
1
Description
Bereavement score in the Caregiver Anticipatory Assessment Scale
Timepoint
Bereavement measurement is done at the beginning of the study and before the start of therapeutic interventions and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and the measurement is done in the follow-up sessions with an interval of two months after the end of the treatment. will be
Method of measurement
Caregiver Anticipatory Grief Assessment Scale
2
Description
The score of coping strategies in the Jalovis coping scale questionnaire
Timepoint
Coping strategies are carried out at the beginning of the study and before the start of therapeutic interventions and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and the measurement is done in the follow-up sessions with an interval of two months after the end of the treatment. will be
Method of measurement
Jallowis coping questionnaire
3
Description
Quality of life score in the quality of life questionnaire
Timepoint
The quality of life is measured at the beginning of the study and before the start of treatment interventions and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and the measurement is done in the follow-up sessions with an interval of two months after the end of the treatment. to be
Method of measurement
Quality of life questionnaire
4
Description
The score of psychological disturbances in Wechsler's standard psychological distress questionnaire form 10 questions
Timepoint
Psychological disturbances
Method of measurement
Wechsler psychological distress scale
5
Description
The score of symptoms related to sleep disturbances in the Pittsburgh Sleep Questionnaire
Timepoint
Symptoms related to sleep disturbances are measured at the beginning of the study and before the start of therapeutic interventions, and then at the end of the treatment sessions, which are 8 sessions in one treatment and 10 sessions in the other treatment, and measurements are taken in follow-up sessions with an interval of two months after The treatment is completed
Method of measurement
Petersburg Sleep Questionnaire
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1 on which cognitive behavioral therapy is implemented
Category
Treatment - Other
2
Description
Intervention group: Intervention group 2, on which emotion-oriented therapy is implemented
Category
Treatment - Other
3
Description
Control group: The number of people in the control group is 15 who do not receive any treatment
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Cancer Control Charitable Institute
Full name of responsible person
Mohammadreza Khodabakhsh
Street address
No. 4 between Qayim 2 and Ahmed Abad Margin Ahmad Abad Blvd.
City
Mashhad
Province
Razavi Khorasan
Postal code
9177915594
Phone
+98 51 3847 3388
Email
arezoo.habibi051@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Neyshabour University of Medical Sciences
Full name of responsible person
Mohamaderza Khodabakhsh
Street address
headquarter of Neishabur medical sciences facultyMoalem squareFarhangian town
City
Nashabor
Province
Razavi Khorasan
Postal code
9318614139
Phone
+98 51 4262 7522
Email
mr_khodabakhsh@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Neyshabour University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Habibi
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 16، South Kausar 12، South Kausar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177915594
Phone
+98 51 3882 9543
Email
arezoo.habibi051@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Habibi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 16، South Kausar 12، South Kausar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177915594
Phone
+98 51 3882 9543
Email
arezoo.habibi051@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Arezoo Habibi
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 16، South Kausar 12، South Kausar Blvd
City
Mashhad
Province
Razavi Khorasan
Postal code
9177915594
Phone
+98 51 3882 9543
Email
arezoo.habibi051@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Comparing the effectiveness of cognitive behavioral therapy and emotional focused therapy on
grief, psychological distress, symptoms related to sleep disturbances, coping strategies and
quality of life in caregivers of cancer patients
When the data will become available and for how long
Starting from February 1402 and with a period of 6 months
To whom data/document is available
Academic sciences
Under which criteria data/document could be used
The general public
From where data/document is obtainable
09151079787
What processes are involved for a request to access data/document