Comparison of the Effectiveness of compassion focused therapy (CFT) and emotional schema therapy (EST) on cancer related fatigue, self-care behaviors and emotional self-regulation in cancer patients.
Comparison of the effectiveness of compassion-focused therapy and emotional schema therapy on cancer fatigue, self-care behaviors and emotional self-regulation in cancer patients
Design
A clinical trial with a control group, with parallel, randomized groups, on 45 patients, uses the website www.randomization.com for randomization.
Settings and conduct
All information and contents related to theoretical foundations are compiled using the library method and after reviewing books, articles and dissertations related to the research topic as well as information available in Internet databases, in order to achieve the results of existing hypotheses, The quasi-experimental method is used based on treatment protocols. The statistical population of the present study is all cancer patients referred to the non-governmental center of oncology in Urmia in 1399. After identifying cancer patients based on patient's records, 45 patients who met the inclusion criteria are identified and randomly assigned to the experimental and control groups
Participants/Inclusion and exclusion criteria
Entry criteria for subjects:
1. Minimum education at the diploma level
2. Conscious satisfaction with participating in research
3.Not receiving a psychotherapy at the same time
Criteria for leaving the subjects:
1. Existence of mental disorders requiring immediate treatment (such as symptoms of psychosis and substance abuse)
Intervention groups
Intervention group 1: Intervention group 1 receives compassion-focused therapy for 8 sessions.
Intervention group 2: Intervention group 2 receives emotional schema therapy for 12 sessions.
Intervention group 3: Intervention group 3 is the control group and dose not receive any therapy.
Main outcome variables
Cancer related fatigue; self-care behaviors; emotional self-regulation
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200108046059N1
Registration date:2020-09-09, 1399/06/19
Registration timing:retrospective
Last update:2020-09-09, 1399/06/19
Update count:0
Registration date
2020-09-09, 1399/06/19
Registrant information
Name
Farinaz Tabibzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 44 3382 8912
Email address
tabibzadeh_f@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-08-05, 1399/05/15
Expected recruitment end date
2020-08-21, 1399/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of compassion focused therapy (CFT) and emotional schema therapy (EST) on cancer related fatigue, self-care behaviors and emotional self-regulation in cancer patients.
Public title
Comparison of compassion focused therapy (CFT) and emotional schema therapy (EST) in cancer patients.
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum education at the diploma level
Conscious satisfaction with participating in research
With at least 6 months of illness and undergoing chemotherapy or radiation therapy
Minimum age 40 and maximum age 60 years
Not receiving a psychotherapy at the same time
Exclusion criteria:
Existence of mental disorders requiring immediate treatment (such as symptoms of psychosis and substance abuse)
Age
From 40 years old to 60 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 randomization process is done using the site www.randomization.com. In order to hide the random allocation, a sealed envelope with a random sequence is used. In such way, that the number of sample volume is 45 people, the envelope is made By the person in charge of the reception center and each of the random sequences created is recorded on a card and the cards are placed in the letter envelopes. in order to maintain the random sequence, on the outer surface of the envelopes are numbered in the same way.Finally, the letter envelopes are glued and placed in a box, respectively. According to the order of entry of eligible participants to the study, one of the envelopes is opened and the assigned group of the participant is revealed. During this period, the researcher and participants are not aware of the assignment of the experiment and control group.
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 Tonekabon Azad University
Street address
3 km of Chalous road, Valiabad, Islamic Azad University of Tonekabon
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Approval date
2020-07-26, 1399/05/05
Ethics committee reference number
IR.IAU.TON.REC.1399.013
Health conditions studied
1
Description of health condition studied
Cancer patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Self-care behaviors Score from the Esmi 2016 Questionnaire
Timepoint
Assessing self-care behaviors before and after the intervention
Method of measurement
Esmi Self-care behaviors in cancer patients questionnaire 2016
2
Description
Cancer Fatigue Score from the Okoyama 2000 Questionnaire
Timepoint
Assessing cancer fatigue before and after the intervention
Method of measurement
Okoyama Cancer Fatigue Questionnaire 2000
3
Description
Emotional self-regulation score of Hoffman and Kashedan 2010 questionnaire
Timepoint
Assessment of emotional self-regulation before and after the intervention
Method of measurement
Hoffman and Kashedan Emotional Self-Regulation Questionnaire 2010
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Intervention group 1: Compassion-focused therapy group: Content of compassion-focused therapy intervention sessions: The first session. Performing a pre-test, therapeutic logic based on self-compassion and understanding compassion and self-compassion. Session 2. Patients are asked to try to identify how they think and behave towards themselves. Session 3. Use compassionate imaging skills and use soothing breathing techniques. Session 4. Using the technique of mindfulness for patients. Session 5. In this session, the technique of writing a letter of daily compassion and promoting self-compassion is done by emotional discharge. Sixth session. In this session, pathology of factors that cause fear and repulsion of patients to Self-compassion is checked. Seventh session. Teaching methods to deal with the factors of self-compassion and the use of relaxation techniques. Summarize the sessions, make final suggestions and practice, and finally perform a post-test.
Category
Behavior
2
Description
Intervention group: Intervention group 2: Emotional schema therapy group: Session 1. Establishing a therapeutic relationship, presenting treatment logic and therapeutic goals, presenting etiology and treatment model from the emotional schema therapy approach. Session 2. Normal and difficult emotions Well done, paying attention to the patient's painful emotions and normalizing them, emotional self-awareness, emotion education and introduction, identifying and labeling emotions, distinguishing between different emotions, identifying emotions in physical and psychological state. Session 3. Self-assessment with the aim of recognizing experience Self-assessment, self-assessment to identify the level of emotional vulnerability in the individual, self-assessment to identify emotion regulation strategies, cognitive consequences of emotional reactions, physiological consequences of emotional reactions, behavioral consequences of emotional reactions and the relationship between the three. Anger excitement and ways to overcome anger. Session 4. Addressing the emotional schemas identified in the patient, verbal challenge and Socratic dialogue. Session 5. Addressing other emotional schemas identified in the patient and the verbal challenge and Socratic dialogue, teaching the technique of writing negative memories with the aim of facilitating emotional processing. Session 6. Preventing from social isolation. Avoidance, problem-solving strategy training, interpersonal skills training (dialogue, assertiveness and conflict resolution), introductory introduction to the concept of emotion acceptance and accreditation. Seventh session. Helping patients to generate and challenge emotions, identify assessments Mistakes and their effects on emotional states. Session 8. Introducing the types of negative beliefs about emotions and challenging them, identifying miscalculations and their effects on emotional states. Ninth session. Identifying the extent and method of using inhibition strategies And examining its emotional consequences, training to express emotion, exposure, training in emotional release and relaxation. Session 10. Discussion about the severity of schemas, before and after exposure, addressing the patient's remnant. Session 11. Review sessions and practice learned skills. Session 12. Work on treatment plan (recurrence prevention) , Planning for remedial sessions, homework, commitment to continuous use of treatment exercises.
Category
Behavior
3
Description
Control group:Control group: do not receive any intervention
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Non-governmental center of oncology in Urmia city
Full name of responsible person
Farinaz Tabibzadeh
Street address
North Khayyam, in front of Quds Clinic
City
Urmia
Province
West Azarbaijan
Postal code
5713733364
Phone
+98 44 3224 1448
Email
Eishioskuei@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tonekabon Azad University
Full name of responsible person
Masood Ghane
Street address
3 km of Chalous road, Tonekabon Azad University
City
Tonekabon
Province
Mazandaran
Postal code
4684161167
Phone
+98 11 5427 1510
Email
masoodghane@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tonekabon 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 of Tonekabon
Full name of responsible person
Farinaz Tabibzadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8 ,Alley 27, Sheikh Tappeh Ave., Urmia town
City
Urmia
Province
West Azarbaijan
Postal code
5719935751
Phone
+98 44 3343 8535
Email
tabibzadeh_f@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University of Tonekabon
Full name of responsible person
Farinaz Tabibzadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8 ,Alley 27, Sheikh Tappeh Ave., Urmia town
City
Urmia
Province
West Azarbaijan
Postal code
5719935751
Phone
+98 44 3343 8535
Email
tabibzadeh_f@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Tonekabon
Full name of responsible person
Farinaz Tabibzadeh
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 8 , Alley 27 , Sheikh Tappeh Ave., Urmia town
City
Urmia
Province
West Azarbaijan
Postal code
5719935751
Phone
+98 44 3343 8535
Email
tabibzadeh_f@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
Undecided - It is not yet known if there will be a plan to make this available
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