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Comparison of the Effectiveness of Integrated Schema Therapy and Mindfulness, Emotion Efficacy Therapy and Caregiver base Mindfulness Therapy on Entrapment, Guilt, Burden, Compassion Fatigue and Sense of Competence in Caregiving Patients with Dementia

Protocol summary

Study aim
1. Comparison of the Effectiveness of Integrated Schema Therapy and Mindfulness, Emotion Efficacy Therapy and Caregiver base Mindfulness Therapy on Entrapment, Guilt, Burden, Compassion Fatigue and Sense of Competence in Caregiving Patients with Dementia
Design
A randomized, one way blinded, sham controlled clinical trial with a parallel group design of 72participents. Excel software is used for randomization.
Settings and conduct
The method of conducting the present study will be slightly quasi-experimental. Before entering each of the stages and starting the research, first the necessary permits for conducting the research, such as referral letters to medical centers for dementia caregivers and patients, and the code of ethics will be obtained. Officials of medical centers will collect data.
Participants/Inclusion and exclusion criteria
Possible diagnosis of moderate or severe cognitive impairment in patients; Having at least one restriction on activities of daily living, or at least two dependencies on instrumental activities; Age 30 years and older; Caring for a relative with dementia for at least 6 months, at least four hours a day; Failure to receive psychiatric and psychological therapies; Average to moderate to high levels of depression, anxiety and stress
Intervention groups
Participants will be randomly assigned to three experimental groups and a control group, with a mindfulness and schema therapy therapy package(8 sessions of 90 minutes), emotional efficiency (80 sessions of 90 minutes), and a caring mindfulness therapy (8 sessions of 90 minutes) for treatment groups will be executed.
Main outcome variables
Entrapment, Guilt, Burden, Compassion Fatigue and Sense of Competence

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220127053841N1
Registration date: 2022-04-18, 1401/01/29
Registration timing: prospective

Last update: 2022-04-18, 1401/01/29
Update count: 0
Registration date
2022-04-18, 1401/01/29
Registrant information
Name
Nahid Ramezani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3629 1196
Email address
mnahidramezanii@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-05-05, 1401/02/15
Expected recruitment end date
2022-06-05, 1401/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Integrated Schema Therapy and Mindfulness, Emotion Efficacy Therapy and Caregiver base Mindfulness Therapy on Entrapment, Guilt, Burden, Compassion Fatigue and Sense of Competence in Caregiving Patients with Dementia
Public title
Effect of Integrated Schema Therapy and Mindfulness on Improving Psychological Symptoms in Caregiving Patients with Dementia
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Possible diagnosis of patients (recipients of care) with the diagnosis of a specialist doctor, or a short mental state test, which indicates moderate or severe cognitive impairment of patients At least one restriction on the activities of daily living, or at least two dependencies on the instrumental activities of the patients's daily life Being 30 years old and older Taking care of a relative with dementia for at least 6 months, at least four hours a day Not being under psychiatric and psychological treatments Achieving a moderate to high level of depression, anxiety and stress in the DOS questionnaire (25-40)
Exclusion criteria:
Having two sessions of absence in the intervention process Having cognitive, physical, sensory or language barriers that may prevent participation in the study Receiving psychological treatment Having previous experience in the therapies used in the research Age less than 30 years
Age
From 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Data analyser
Sample size
Target sample size: 72
Randomization (investigator's opinion)
Randomized
Randomization description
The purpose of random allocation is that the clinician can not predict the treatment of the disease. Random allocation of the type of treatment or allocation random heart is the study of a clinical trial. The samples will be identified by random blocking method and using random number table, Random Allocation Software software. Block: This method is used to prevent significant imbalances in the number of participants assigned to each group.Block randomization ensures that no significant imbalances occur between groups during randomization. At certain points, the number of participants in each group is equal.For this method, the size of each block must first be specified (for example, a block of four), then write a list of blocks and assign numbers to them (AABB (1) -ABAB (2) -ABBA (3) -BBAA (4) -BABA (5) - BAAB (6)), then select random numbers between one to 6 (for example 1, 4, 5, etc.) and finally specify the treatment allocation list based on previous random numbers (… AABB-BBAA-BABA-) , Will be intervened in four groups including three groups and one control group.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants, or in other words, people who have been invited to participate in the study and after obtaining informed consent have been classified into intervention groups, may not know the main purpose of the study, these people only know that in a study They participate, which will lead to the improvement of their psychological problems, and they are only unaware of the allocation of groups. The statistical analyst does not know the content of the treatment sessions, but the hypotheses, goals, and study questions.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Isfahan Branch (Khorasgan)
Street address
No. 5, Banafshe Alley, Arasteh Alley(35), Nazar Gharbi St.
City
Isfahan
Province
Isfehan
Postal code
8175646391
Approval date
2022-02-22, 1400/12/03
Ethics committee reference number
IR.IAU.KHUISF.REC.1400.337

Health conditions studied

1

Description of health condition studied
Dementia
ICD-10 code
F03
ICD-10 code description
Unspecified dementia

Primary outcomes

1

Description
Entrapment is a special type of thinking and feeling that refers to trapping or trapping a person in a situation that he wants to avoid. Entrapment as a forced cessation of human activity and the inability of the individual to escape from the situation.
Timepoint
At the beginning of the study, after the intervention and three months after the intervention
Method of measurement
Gilbert and Allen Entrapment(Failure)Questionnaire

2

Description
Guilty score in the questionnaire of Losada et al., Which includes ‌guilt about doing wrong by the care recipient,guilt about not rising to the occasion as caregivers, guilt about self-care, guilt about neglecting other relatives,and guilt about having negative feelings towards other people
Timepoint
At the beginning of the study, after the intervention and three months after the intervention
Method of measurement
The CaregiverGuilt Questionnaire of Losada et al(2010)

3

Description
The burden of care includes personal, social, emotional and economic pressures
Timepoint
At the beginning of the study, after the intervention and three months after the intervention
Method of measurement
Caregiver's burden questionnaire

4

Description
Compassion fatigue ("compassionate" "a state of fatigue and dysfunction (biological, psychological, and social) that results from prolonged exposure to the stress of compassion"; Caregivers are exposed to the suffering of their patients or are too emotional
Timepoint
At the beginning of the study, after the intervention and three months after the intervention
Method of measurement
Vocational life quality Stam

5

Description
A sense of competence expresses caregivers' feelings about their ability to care for a patient
Timepoint
At the beginning of the study, after the intervention and three months after the intervention
Method of measurement
Sense of competence questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group1:Intervention (package therapy) mindfulness and schema therapy (van Vreeswijk,M.,Broersen,J.,&Schurink (2014) This program has 8 training sessions and two follow-up sessions ‌‌Messages once a week for one and a half hours. Session 1:Schemas, mindsets and mindfulness training-Introduction-Explanation-Practice-Homework Session 2: Conscious attention to the environment-Breathing-Sounds-Physical feelings-Thoughts-Emotions-Released consciousness-Homework Session 3: Conscious attention to breathing- Painful Memories - Walking - Three-Minute Breathing Space - Homework Session 4:Conscious Attention to Schema Coping (Coping with Problems) - Conscious Attention to Schemas - Familiarity with Schemas - Confectionery -Conscious Attention - Homework Session 5:Permission and Acceptance of everything that exists (reaction in the form of great mentalities Healthy year and happy child-Interactive conscious attention interaction with loved ones) -Conscious three-minute conscious attention to the schema-Accepting the conscious attention of oneself and others-Homework Session 6:Plans-‌‌ Reality or fantasy Conscious attention to walking-Leaving the schemes to themselves-Homework Session 7:Taking care of yourself through a healthy adult and happy child-Conscious attention to healthy adults and happy children-Preparing for the future-Needs of healthy adults and happy children-Conscious attention to schemas حکم as pure thoughts-Homework Session 8 :Future - Schemas and mentalities in the future - Conscious attention to yourself as a child and adult - Stunt combined with awareness of schema and mentality in individual interactions Two follow-up sessions: 1 - one month after treatment and 2 - two months later - time Shorter - Emphasis on maintaining and improving previously acquired skills
Category
Lifestyle

2

Description
Intervention group 2:Intervention (treatment package) Emotional efficiency (McKay and West (2016)) This program has 8 training sessions and two follow-up sessions ‌‌Messages once a week for one and a half hours. Session 1:Observation and acceptance: ‌Awareness of excitement Session 2:Conscious mind acceptance: ‌Wave riding on excitement Session 3: Value-Based Action - Part One Session 4: Value-Based Action - Part II Session 5: ‌‌Conscious Mind Coping: ‌‌‌Loneliness and self-relaxation Session 6:Conscious mind confrontation: مقControversial thoughts and fundamental acceptance Session 7:Conscious mind confrontation: ‌Return attention and rest time Session 8: ‌ Fixation, unwind and summarizing
Category
Lifestyle

3

Description
Intervention group 3: intervention (treatment package) mindfulness of the caregiver of Rezek(2015) This program has 8 training sessions and two follow-up sessions. Meetings last once a week for an hour and a half. Session 1: Introduction to mindfulness for caregivers - Explain the course and how the mind and body interact against stress -Training body postures in mindfulness exercises (sitting and lying down) Session 2:Breathing practice training (5 minutes) for caregivers ‌‌ ‌‌ Mindfulness training training ‌‌ Conscious care for caregivers Introductory mind training training for caregivers Session 3:Breathing training training (relaxing moments in less than 2 minutes) -Shower training training ‌‌Conscious mind-training-Focusing training training (30 minutes) -Homework Session 4:Breathing practice training (5 minutes) for caregivers - Mountain meditation practice training for caregivers - Mindfulness training training for special caregivers thoughts - Homework Session 5:Breathing training training (relaxation moments in less than 2 minutes) - Training to choose to change the focus of caregivers as a solution to deal with unpleasant thoughts and emotions - Homework Session 6:Breathing training training (5 minutes) for caregivers - Training training for body posture training for caregivers - Training training for self-care for caregivers - Training training for setting boundaries along with the volume of work for caregivers - Homework: Special caregivers' body posture - Special caregivers' self-care exercise - Boundaries exercise along with the volume of caregivers' workload Session 7:Breathing training training (relaxing moments in less than 2 minutes) - Training training ‌‌ Mindful walking-Conscious training training ‌‌ Mindfulness training for caregivers, Homework Session 8:Breathing training training (5 minutes) for caregivers - Limiting exercises along with the volume of work for caregivers - Teaching strategies to deal with resistance to exercise - Homework
Category
Lifestyle

4

Description
Control group: A group that is not subject to any intervention. They only complete the questionnaires before and after reading. If they wish, they can intervene after the end of the study.
Category
Lifestyle

Recruitment centers

1

Recruitment center
Name of recruitment center
private clinic
Full name of responsible person
Majid Barekatain
Street address
first floor, Sarv Building, in front of Tejarat Bank, between Nikbakht and Sheikh Mofid Streets, Sheikh Sadough North Street
City
Isfahan
Province
Isfehan
Postal code
8123456789
Phone
+98 31 3664 0239
Email
majidbarekatain1968@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farsad Zamani
Street address
University Blvd, Arghavanieh,East Jay St
City
Isfahan
Province
Isfehan
Postal code
۳۹۹۹۸۸۱۵۵۱
Phone
+98 31 3535 4001
Fax
Email
info@khuisf.ac.ir
Web page address
http://new.khuisf.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University Isfahan (Khorasgan) Branch.
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
Islamic Azad University
Full name of responsible person
Nahid Ramezani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No5, Banafsheh Allye, Arasteh Alley(35), West Nazar
City
Esfahan
Province
Isfehan
Postal code
8175646391
Phone
+98 31 3629 1196
Fax
Email
mnahidramezanii@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Ramezani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No5, Banafsheh Allye, Arasteh Alley(35), West Nazar
City
Esfahan
Province
Isfehan
Postal code
8175646391
Phone
+98 31 3629 1196
Fax
Email
mnahidramezanii@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nahid Ramezani
Position
Student
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No5, Banafsheh Allye, Arasteh Alley(35), West Nazar
City
Esfahan
Province
Isfehan
Postal code
8175646391
Phone
+98 31 3629 1196
Fax
Email
mnahidramezanii@yahoo.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
Participant data file only in general and without mentioning the name and address of the participants (number-gender-age-education). The study protocol can also be published as a table. The statistical analysis map can be published in the form of tables and statistical results. The informed consent can be published in full. The results of applied research can be published. Statistical methods and statistical analysis can be published. The obtained data can be published in the form of tables. All of the above can be provided to participants in accordance with the instructions of the journals and in case of no damage.
When the data will become available and for how long
The start of the access period is with the opinion and agreement of the relevant journals.
To whom data/document is available
It will be accessible to all people who have access to authoritative sources for publishing articles such as reputable journals and the results of this research can be used for them.
Under which criteria data/document could be used
All cases of using the documents will be possible with the permission of the university of study and professors related to the research and in compliance with the existing rules and regulations.
From where data/document is obtainable
Reputable journals in which research-related articles are published. The e-mails of the supervisors, advisors and students implementing the project and their university website will be provided to the applicants using the results in accordance with the rules and regulations and maintaining the confidentiality of the participants.
What processes are involved for a request to access data/document
Applicable requests will be answered as soon as possible if the rules related to research documents are observed.
Comments
All of the above can be done within the framework of the rules and regulations of research and publication in relevant journals and universities. If a case is not within the scope of these laws, it will not be published. A special case is to maintain the confidentiality of participants' information and not to harm them.
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