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the effectiveness of acceptance and commitment therapy (ACT) on anxiety, depression, marital satisfaction, pain acceptance, psychological flexibility and body composition among married people with breast cancer .

Protocol summary

Study aim
the effectiveness of acceptance and commitment therapy (ACT) on anxiety, depression, marital satisfaction, pain acceptance, psychological flexibility and body composition among married people with breast cancer
Design
This research is a randomized study with two groups of acceptance and commitment therapy and control group. Subsequently, 40 breast cancer patients will be selected based on target selection criteria. The participants in the intervention and control groups Randomly ordered.
Settings and conduct
The research site is Ayatollah Yasrebi Hospital in Kashan. For sampling, patient's contact number was first delivered from the hospital and 40 patients were randomly assigned to two groups (one treatment group, one control group). This research is a blind clinical trial. The members of each group will come to the treatment in different days and hours, and the two members will not meet each other.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definitive diagnosis of breast cancer and at least 6 months of illness, lack of other serious diseases, having at least 18 years of age, having at least guidance school of literacy, being married, tendency to participate in the program, depression score higher or equal to 10 according to DASS-21 test, anxiety score higher or equal to 8 according to DASS-21 test Exclusion criteria: drug use, suicidal thoughts,Participation in psychiatric intervention while conducting research
Intervention groups
Acceptance and commitment therapy group: 8 sessions, once a week Control group: In this group, members will continue to take their usual treatment.
Main outcome variables
Anxiety, Depression, Marital Satisfaction, Acceptance of Pain and Psychological Flexibility and Body Composition

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190518043620N1
Registration date: 2020-02-14, 1398/11/25
Registration timing: retrospective

Last update: 2020-02-14, 1398/11/25
Update count: 0
Registration date
2020-02-14, 1398/11/25
Registrant information
Name
Vajiheh Ghorbani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3442 3755
Email address
ghorbani-v@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
the effectiveness of acceptance and commitment therapy (ACT) on anxiety, depression, marital satisfaction, pain acceptance, psychological flexibility and body composition among married people with breast cancer .
Public title
the effectiveness of acceptance and commitment therapy (ACT) on anxiety, depression, marital satisfaction, pain acceptance, psychological flexibility and body composition among married people with breast cancer .
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of breast cancer and at least 6 months of illness lack of other serious diseases (chronic heart, kidney, pulmonary diseases in the advanced stages, etc.) Having at least 18 years of age Having at least guidance school of literacy Being married Tendency to participate in the program Depression score higher or equal to 10 according to DASS-21 test Anxiety score higher or equal to 8 according to DASS-21 test
Exclusion criteria:
Drug use Suicidal thoughts Participation in psychiatric intervention while conducting research
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
40 patients with breast cancer are intentionally selected. They are then randomly assigned to two groups (ACT, control, 20).
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, after the participants are selected, we begin the treatment randomly and without knowing the two groups in this study in the intervention or control group, but the treatment that will be applied to them will be explained. The blindness of the participants in the treatment is that they are unaware that there is another group. But after the end, they will know about the existence of the other group and they will be treated if they wish. The researcher is aware of the existence of an intervention group and control.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethical Committee of Kashan University of Medical Sciences
Street address
Ghotb Ravandi Boulevard
City
Kashan
Province
Isfehan
Postal code
3713979671
Approval date
2019-01-07, 1397/10/17
Ethics committee reference number
IR.KAUMS.MEDNT.REC.1397.092

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50.9
ICD-10 code description
Malignant neoplasm of breast of unspecified site

Primary outcomes

1

Description
anxiety
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Anxiety-Depression-Stress Questionnaire 21

2

Description
depression
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Anxiety-Depression-Stress Questionnaire 21

3

Description
Marital Satisfaction
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Enrich marital satisfaction questionnaire

4

Description
pain acceptance
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Chronic Pain Acceptance Questionnaire(CPAQ)

5

Description
psychological flexibility
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Acceptance and Action Questionnaire (AAQ-II)

6

Description
body composition
Timepoint
Before intervention, after intervention, two months after intervention
Method of measurement
Inbody device

Secondary outcomes

empty

Intervention groups

1

Description
Control group: The control group is the same group that does not receive any treatment except its medication.
Category
Other

2

Description
Intervention group: Acceptance and commitment therapy,an integrated therapeutic approach developed by Hayes, Straussal and Wilson, consisting of eight 90-minute therapeutic sessions, held for 8 consecutive weeks.Instead of changing cognitions, this treatment seeks to enhance a person's psychological connection to his or her thoughts and feelings, and includes six central processes that lead to psychological flexibility.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Beheshti Hospital of Kashan
Full name of responsible person
Vajiheh GHorbani
Street address
Shahid Beheshti Hospital, Kashan University of Medical Sciences, Boulevard Ravandi,Kashan,Isfahan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3442 3755
Email
ADRC@kaums.ac.ir

2

Recruitment center
Name of recruitment center
Ayatollah Yasrebi Hospital of Kashan
Full name of responsible person
Dr. Mostafa Sarvizadeh
Street address
Ayatollah Yasrebi Hospital,Parastar Blvd, Qotb Ravandi Boulevard,Kashan
City
Kashan
Province
Isfehan
Postal code
8715981151
Phone
+98 31 3442 3755
Email
info@yasrebihospital.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Dr.Hamid Reza Banafsheh
Street address
Kashan University of Medical Sciences,Ghotb Ravandi Blvd
City
Kashan
Province
Isfehan
Postal code
88715973474
Phone
+98 31 5554 0021
Email
medicine@kaums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kashan University of Medical Sciences
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
Kashan University of Medical Sciences
Full name of responsible person
Vajiheh Ghorbani
Position
Master of clinical psychology student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 47 , Impasse Mariam , Aref St , Jaber Ansari St,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196867444
Phone
+98 31 3442 3755
Email
vajihehghorbani1@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Vajiheh Ghorbani
Position
Master of clinical psychology student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.47,Impasse Mariam,Aref St,Jaber Ansari St,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196867444
Phone
+98 31 3442 3755
Email
vajihehghorbani1@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kashan University of Medical Sciences
Full name of responsible person
Vajiheh Ghorbani
Position
Master of clinical psychology syudent
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No.47,Impasse Mariam,Aref St,Jabar Ansari St,Isfahan
City
Isfahan
Province
Isfehan
Postal code
8196867444
Phone
+98 31 3442 3755
Email
vajihehghorbani1@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
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