Efficacy of group-based Acceptance and Commitment Therapy on Self-differentiation,Emotion disregulation, Fear of disease progression and mental health in patients with breast cancer
Determine the Effectiveness of ACT Treatment for the Distinction of Patients with Breast Cancer - Determine the Effectiveness of ACT Group Therapy on the Emotion of Patients with Breast Cancer-Determine the Effectiveness of Group Therapy ACT Fear of Progression in Patients with Breast Cancer-Determine the Effectiveness of ACT Therapy on Mental Health of Patients with Breast Cancer.
Design
The trial has intervention and control group. Women with breast cancer who referred to the Toba Clinic who had a history of breast cancer (N = 160), after contact with them, 62 were interviewed and accepted in the classroom, and after a semi-structured interview with a psychiatrist, 45 They did not have a specific problem. They completed the questionnaires. 30 subjects who obtained the necessary scores in the questionnaires and entered the research were selected and randomly divided into two groups of 15 (through codes on each sheet)
Settings and conduct
Women with breast cancer who referred to the Toba in the year 92 and were diagnosed with breast cancer who responded to the call after contact with them. Of these, 62 were interviewed the company, and then From the interview, 45 persons completed the uestionnaires. 30 were selected and randomly divided into two groups: intervention and control, with code on the sheet.
Participants/Inclusion and exclusion criteria
Log-in: between 25 and 60 people are under chemotherapy-not attending other courses for at least 6 months.
Exit: -Cancer to other cancers -Ability to be present due to cancer
-A history of acute mental illness with a psychiatrist's opinion
Intervention groups
ACT is performed in an intervention group of eight 90-minute sessions
Main outcome variables
Self-differentiation, fear of disease progression, emotional regulation and mental health
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181209041894N1
Registration date:2018-12-23, 1397/10/02
Registration timing:retrospective
Last update:2018-12-23, 1397/10/02
Update count:0
Registration date
2018-12-23, 1397/10/02
Registrant information
Name
Maryam Hasannegzad reskati
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3334 0605
Email address
maryam.hasannegzad@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-11-30, 1396/09/09
Expected recruitment end date
2018-03-19, 1396/12/28
Actual recruitment start date
2017-12-30, 1396/10/09
Actual recruitment end date
2018-06-06, 1397/03/16
Trial completion date
2018-06-06, 1397/03/16
Scientific title
Efficacy of group-based Acceptance and Commitment Therapy on Self-differentiation,Emotion disregulation, Fear of disease progression and mental health in patients with breast cancer
Public title
Efficacy of group-based Acceptance and Commitment Therapy in patients with breast cancer
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
- Age between 25 and 60
- People under chemotherapy
- Apart from cancer, there is no physical or psychological illness
- Absence in other courses at least 6 months
Exclusion criteria:
Having other cancers
Inability to attend meetings due to physical illness
A history of acute mental illness with a psychiatrist's opinion
Age
From 25 years old to 60 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Actual sample size reached:
30
Randomization (investigator's opinion)
Randomized
Randomization description
After entering the study, patients are randomly assigned to the first and second groups by computer software. Group 1 treatment groups are treated based on acceptance and commitment, and the second group is the control group under which There is no cure
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of sari Islamic Azad University
Street address
Khazar Blvd. sari Islamic Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Approval date
2018-11-19, 1397/08/28
Ethics committee reference number
IR.IAU.SARI.REC.1397.020
Health conditions studied
1
Description of health condition studied
Effect of ACT Group Therapy on Patients with Breast Cancer
ICD-10 code
F40-F48
ICD-10 code description
F40-F48
Primary outcomes
1
Description
Percentage of people who have a self-differentiating questionnaire score of under 70
Timepoint
At the beginning of the study (before the intervention), the end of the study, two months later
Method of measurement
Dreik-Mordak self-differentiation questionnaire
2
Description
The percentage of people who score in the difficulty questionnaire in adjusting their excitement of Gertz and Roemer are over 108.
Timepoint
At the beginning of the study (before the intervention), the end of the
Method of measurement
Gritz & Roemer's Thrill Setting Questionnaire
3
Description
Percentage of people whose FOP-Q questionnaire score is above 74
Timepoint
At the beginning of the study (before the intervention), the end of the
Method of measurement
, FOP-Q Questionnaire
4
Description
The percentage of people with a general health questionnaire score of 28 (GHQ-28) is above 42
Timepoint
At the beginning of the study (before the intervention), the end of the
Method of measurement
General Health Questionnaire (GHQ-28)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Treatment based on the acceptance and commitment of the third-generation psychotherapy method, which lasts for eight 90-minute sessions. Duration of the intervention in the intervention group is two months. The content of the sessions is with the training of mind, metaphor and homework.over eight 90-minute sessions
Category
Behavior
2
Description
Control group: A group that has received breast cancer diagnosis and has met criteria for entry. No interventions in psychotherapy and medicine.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Toba Sari Specialist and Specialist Center
Full name of responsible person
Bahram Mirzaian
Street address
Khazar Blvd , Sari Islamic Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3444 5761
Email
Bahrammirzaian@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohamad Farsi
Street address
Khazar Blvd, Islamic Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3444 5761
Fax
Email
maryam.hasannegzad@gmail.com
Web page address
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
1
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hasannezhad
Position
PhD Student in Educational Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khazar Bluv, Islamic Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 33340605
Email
maryam.hasannegzad@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hasannezhad
Position
PhD Student in Educational Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khazar Bluv, Islamic Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3334 0605
Email
maryam.hasannegzad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maryam Hasannezhad
Position
PhD Student in Educational Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Khazar Bluv, Islamic Azad University
City
Sari
Province
Mazandaran
Postal code
48164-194
Phone
+98 11 3334 0605
Email
maryam.hasannegzad@gmail.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