Comparison of the efficacy of treatment based on acceptance and commitment and positive psychotherapy on the acceptance of Pain, self-compassion and affects control of cancer patients
Comparison of the efficacy of treatment based on acceptance and commitment and positive psychotherapy on the acceptance of pain, self-compassion and affects control of cancer patients
Design
Study groups will include people with cancer-based on inclusion criteria who will be non-randomly assigned to the experimental and control groups. The sample of the two groups will include 36 people. And will be selected voluntarily and in an accessible manner. Excel software rand function was used for randomization.
Settings and conduct
The present study is a quasi-experimental with a pre-test-post-test design with a control group and a one-month follow-up stage. Subjects are first selected by convenience sampling and randomly assigned to the experimental and control groups. Training is done in Kohgoluyeh city education counseling center.
Participants/Inclusion and exclusion criteria
Diagnosis of cancer by a specialist;
Have a history of at least one year of cancer;
Have at least an education level of diploma
Age range 50-20 years;
Severe mental disorders;
Taking antipsychotic drugs;
Having substance abuse.
Intervention groups
Control group, commitment and acceptance treatment group and positive psychotherapy group
Main outcome variables
Acceptance and commitment, Positive psychotherapy, Acceptance of pain, Self-compassion, Emotion control
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200802048274N1
Registration date:2020-09-05, 1399/06/15
Registration timing:retrospective
Last update:2020-09-05, 1399/06/15
Update count:0
Registration date
2020-09-05, 1399/06/15
Registrant information
Name
Kouroush Fathi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 74 3226 3011
Email address
f_korosh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-19, 1397/11/30
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of treatment based on acceptance and commitment and positive psychotherapy on the acceptance of Pain, self-compassion and affects control of cancer patients
Public title
Comparison of the efficacy of treatment based on acceptance and commitment and positive psychotherapy on the acceptance of Pain, self-compassion and affects control of cancer patients
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Have a history of at least one year of cancer
Have a minimum education level of diploma
Age range 50-20 years
Exclusion criteria:
Do not have acute mental problem
Age
From 20 years old to 50 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
39
Randomization (investigator's opinion)
Not randomized
Randomization description
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
Yasuj University of Medical Sciences
Street address
7 tir
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571865365
Approval date
2020-03-08, 1398/12/18
Ethics committee reference number
IR.YUMS.REC.1398.163
Health conditions studied
1
Description of health condition studied
Cancer
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
One of the important concepts in contemporary theories is how a person reacts and adapts to chronic pain. Accepting pain is the first step in adapting to changes in life in a way that allows the person to continue to work in the living environment and at the same time try to control pain.
Timepoint
At the beginning and before the intervention, immediately after the intervention and 2 months after the last intervention session
Method of measurement
The McCracken Pain Acceptance Scale and the Williams and Chambles Emotion Control Scale will be used to collect data. The McCracken & Wools Pain Acceptance Scale has two components: the tendency to accept pain and active participation and has a total of 20 items, 9 of which are related to the component of tendency to accept pain (items 4, 7, 11, 13, 14, 16, 17, 18 and 20) and its 11 items are related to the active participation component (items 1, 2, 3, 5, 6, 8, 9, 10, 12, 15 and 19). Scoring is done on a Likert scale of 7 degrees. This scale has well shown a good internal consistency with an alpha of 0.82 for the pain acceptance component and 0.78 for the active participation component. The results of factor analysis in the study of McCracken, McLeod and Ecclestone, (2008), confirmed the existence of two factors: the tendency to accept pain and active participation and the validity of this scale has also been confirmed. In Iran, Cronbach's alpha coefficient of this scale has been reported in research 0.87. Emotion Control Scale: This scale has 42 questions made by Williams and Chambels and its purpose is to evaluate the ability to control emotions from the basics of the 15th Amendment. Emotions have a valid internal consistency, the correlation of the test between the subscales of the test, and between the questions of the scale is significant at the level of 0.01 confidence. The validity of the emotion control test among students, teachers, nurses, and professors in Iran is relatively high and has an acceptable level and the test questions are correlated with each other, so the questions of this test are suitable for measuring emotion control.
2
Description
She has defined compassion as a three-component construct that includes kindness to oneself versus self-judgment, human commonalities versus isolation, and awareness versus extreme assimilation
Timepoint
Measurement periods at the beginning and before the intervention, immediately after the intervention and 2 months after the last intervention session
Method of measurement
The McCracken Pain Acceptance Scale and the Williams and Chambles Emotion Control Scale will be used to collect data. The McCracken & Wools Pain Acceptance Scale has two components: tendency to accept pain and active participation, and has a total of 20 items, 9 of which are related to the component of tendency to accept pain (items 4, 7, 11, 13, 14, 16, 17 , 18 and 20) and its 11 items are related to the active participation component (items 1, 2, 3, 5, 6, 8, 9, 10, 12, 15 and 19). Scoring is done on a Likert scale of 7 degrees. This scale has well shown a good internal consistency with alpha of 0.82 for the pain acceptance component and 0.78 for the active participation component. The results of factor analysis in the study of McCracken, McLeod and Ecclestone, (2008), confirmed the existence of two factors: the tendency to accept pain and active participation, and the validity of this scale has also been confirmed. In Iran, Cronbach's alpha coefficient of this scale has been reported in research 0.87. Emotion Control Scale: This scale has 42 questions made by Williams and Chambers and its purpose is to evaluate the ability to control emotions from the basics of the 15th Amendment. Emotions have a valid internal consistency, the correlation of the test between the subscales of the test, and between the questions of the scale is significant at the level of 0.01 confidence. The validity of the emotion control test among students, teachers, nurses and professors in Iran is relatively high and has an acceptable level and the test questions are correlated with each other, so the questions of this test are suitable for measuring emotion control.
3
Description
Emotion control includes controlling anger, depression, anxiety, and positive emotions
Timepoint
Measurement periods at the beginning and before the intervention, immediately after the intervention and 2 months after the last intervention session
Method of measurement
The McCracken Pain Acceptance Scale and the Williams and Chambles Emotion Control Scale will be used to collect data. The McCracken & Wools Pain Acceptance Scale has two components: tendency to accept pain and active participation, and has a total of 20 items, 9 of which are related to the component of tendency to accept pain (items 4, 7, 11, 13, 14, 16, 17 , 18 and 20) and its 11 items are related to the active participation component (items 1, 2, 3, 5, 6, 8, 9, 10, 12, 15 and 19). Scoring is done on a Likert scale of 7 degrees. This scale has well shown a good internal consistency with alpha of 0.82 for the pain acceptance component and 0.78 for the active participation component. The results of factor analysis in the study of McCracken, McLeod and Ecclestone, (2008), confirmed the existence of two factors: the tendency to accept pain and active participation, and the validity of this scale has also been confirmed. In Iran, Cronbach's alpha coefficient of this scale has been reported in research 0.87. Emotion Control Scale: This scale has 42 questions made by Williams and Chambers and its purpose is to evaluate the ability to control emotions from the basics of the 15th Amendment. Emotions have a valid internal consistency, the correlation of the test between the subscales of the test, and between the questions of the scale is significant at the level of 0.01 confidence. The validity of the emotion control test among students, teachers, nurses and professors in Iran is relatively high and has an acceptable level and the test questions are correlated with each other, so the questions of this test are suitable for measuring emotion control.
Secondary outcomes
1
Description
A term for theories and research about what makes life most valuable.
Timepoint
At the beginning and before the intervention, immediately after the intervention and 2 months after the last intervention session
Method of measurement
questionnaire
2
Description
One of the therapies is the third wave, which emphasizes mindfulness, and is based on the acceptance of suffering (embedded in) life and committed action based on values to enjoy a richer life.
Timepoint
At the beginning and before the intervention, immediately after the intervention and 2 months after the last intervention session
Method of measurement
questionnaire
Intervention groups
1
Description
The following treatment protocol was performed in eight sessions. Session 1: 1- Presenting generalities of the group protocol, introducing the members and expectations of the group 2- Short mindfulness meditation 3- Written practice of self-affirmation and expression of values 4- Description of the exercise (homework) Three good events 5- Mindfulness meditation. Session 2: 1- Mindfulness meditation 2- Discussion about practicing three good events 3- Discussion about self-worthwhile results 4- Description of exercise (homework) Strengths 5- Mindfulness meditation. Session 3: 1- Mindfulness meditation 2- Discussion about practicing the use of strengths 3- Description of exercise (homework) Enjoyment 4- Mindfulness meditation. Session 4: 1- Mindfulness meditation 3- Discussion about exercise (homework) Enjoyment 4- Description of exercise (homework) Having a good day 5- Mindfulness meditation. Session 5: 1- Mindfulness meditation 2- Discussion about exercise (homework) Having a good day 3- Introduction of exercise (homework) Appreciation meeting 4- Mindfulness meditation. Session 6: 1- Mindfulness meditation 2- Discussion about exercise (homework) Appreciation meeting 3- Introduction of exercise (homework) Active / constructive answer 4- Mindfulness meditation. Session 7: 1- Mindfulness meditation 2- Discussion about practice (homework) Active / constructive answer 3- Introduction of biography writing practice 4- Mindfulness meditation. Session 8: 1- Mindfulness meditation 2- Discussion about (homework) Writing a biography 3- Introducing positive service assignment 4- Mindfulness meditation 5- Discussion about the final session.
Category
Behavior
2
Description
Control group: will not receive any intervention.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Kohgiluyeh city hospitals and medical centers
Full name of responsible person
Kourosh Davari, PhD
Street address
Sepah street - Imam Khomeini hospital in Dehdasht
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571865365
Phone
+98 74 3226 0000
Email
F_korosh@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masoud Shahbazi ph.d
Street address
Islamic azad University of Ahvaz
City
Ahvaz
Province
Khouzestan
Postal code
757180000
Phone
+98 74 3227 0000
Email
Masoudshahbazi66@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
does not have
Proportion provided by this source
1
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kouroush Fathi
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Dehdasht 7th of Tir street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571759381
Phone
+98 74 3226 3011
Email
F_korosh@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kouroush Fathi
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
7th of Tir Street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571759381
Phone
+98 74 3226 3011
Email
f_korosh@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kouroush Fathi
Position
Employee
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
7th of Tir street
City
Dehdasht
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7571759381
Phone
+98 74 3226 3011
Email
f_korosh@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
No - There is not a plan to make this available
Clinical Study Report
No - There is not 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
Cannot share at this time.
When the data will become available and for how long
Cannot share at this time.
To whom data/document is available
Cannot share at this time.
Under which criteria data/document could be used
Cannot share at this time.
From where data/document is obtainable
Cannot share at this time.
What processes are involved for a request to access data/document