Effectiveness of compassion-focused therapy on perceived stress, body image anxiety, valuing body and psychological distress in the women suffering from breast cancer
Treatment of perceived stress, concerns of body image and psychological distress in women with breast cancer
Design
A clinical trial involving a control group included all 20-60 year old breast cancer patients. 30 female patients with breast cancer were selected and simple randomization using random numbers table in intervention and control groups. For the intervention group, Based Compassion-Focused Therapy and control group, Treatment-as-usual(TAU) was used.
Settings and conduct
compassion-focused therapy was used in 8 treatment sessions of 90 minutes , one session each week and consecutive for the treatment of perceived stress, concerns of body image and psychological distress in women with breast cancer. Sampling and treatment was done in Isfahan Ala' cancer prevention and control center. Blinding is not done in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Having a breast cancer disease by diagnosing an oncologist, From 20 years old to 60 years old, Have at least a diploma degree, Having a physical and cognitive ability to participate in the study, Not having another psychotherapy record Informed consent and willingness to participate in research.
Exclusion criteria: having psychiatric disorders (based on DSM-5), advanced cancer and other cancers.
Intervention groups
The intervention group received 8 compassion-focused therapy sessions in a two and a half months at a weekly 90-minute session. The control group also used the current treatment (TAU).
Main outcome variables
Perceived Stress, Body Image Anxiety, Valuing Body and Psychological Distress
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190118042403N1
Registration date:2019-02-20, 1397/12/01
Registration timing:retrospective
Last update:2019-02-20, 1397/12/01
Update count:0
Registration date
2019-02-20, 1397/12/01
Registrant information
Name
Razieh Purhoseini
Name of organization / entity
Islamic Azad University, Isfahan (Khorasgan) Branch
Country
Iran (Islamic Republic of)
Phone
+98 31 3535 4001
Email address
m.porhoseini1361@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-30, 1397/03/09
Expected recruitment end date
2018-07-31, 1397/05/09
Actual recruitment start date
2018-06-14, 1397/03/24
Actual recruitment end date
2018-08-23, 1397/06/01
Trial completion date
2018-12-07, 1397/09/16
Scientific title
Effectiveness of compassion-focused therapy on perceived stress, body image anxiety, valuing body and psychological distress in the women suffering from breast cancer
Public title
The effect of compassion focused therapy on perceived stress, body image anxiety, valuing body and psychological distress.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a breast cancer disease by diagnosing an oncologist
From 20 years old to 60 years old
Have at least a diploma degree
Having a physical and cognitive ability to participate in the study
Not having another psychotherapy record
Informed consent and willingness to participate in research
Exclusion criteria:
Having psychiatric disorders (based on DSM-5)
Advanced cancer disease
Affected by a variety of other cancers
Age
From 20 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
In this study, 30 patients with breast cancer were selected based on the inclusion and exclusion criteria. Through a Simple randomization method, 15 people were assigned to the intervention group and 15 were assigned to the control group using the random numbers table. In the use of random numbers table, first, how to read the numbers in the table were determined. Then the even numbers for the intervention group and the odd numbers for the control group were considered.
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 Islamic Azad University Of Khorasgan
Street address
East Gey Street ., Arghavanieh., University Blvd
City
Isfehan
Province
Isfehan
Postal code
8155139998
Approval date
2018-06-24, 1397/04/03
Ethics committee reference number
IR.IAU.KHUISF.REC.1397.111
Health conditions studied
1
Description of health condition studied
Breast cancer
ICD-10 code
c50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
Perceived Stress Score in Perceived Stress Questionnaire
Timepoint
Perceived stress questionnaire before intervention, after intervention and 45 days after intervention
Method of measurement
perceived stress questionnaire
2
Description
Psychological Distress Score in Psychological Distress Questionnaire
Timepoint
Psychological Distress questionnaire before intervention, after intervention and 45 days after intervention
Method of measurement
psychological distress questionnaire
3
Description
Body Image Anxiety Score in Body Image Anxiety Questionnaire
Timepoint
Body Image Anxiety questionnaire before intervention, after intervention and 45 days after intervention
Method of measurement
Body Image Anxiety questionnaire
4
Description
Valuing Body
Timepoint
Valuing Body questionnaire before intervention, after intervention and 45 days after intervention
Method of measurement
Valuing Body questionnaire
Secondary outcomes
1
Description
therapeutic alliance
Timepoint
after intervention on experimental group
Method of measurement
Working Alliance Inventory-Short Revised (WAI-SR)
Intervention groups
1
Description
Intervention group: Group-Based Compassion-Focused Therapy was used for treatment in the intervention group. The treatment group performed a 90 minute session per week. The number of sessions according to the protocol was considered 8 sessions. Compassion-focused therapy aims to help promote mental and emotional healing by encouraging patients in treatment to be compassionate toward themselves and other people. Compassion, both toward the self and toward others, is an emotional response believed by many to be an essential aspect of well-being. The mentioned treatment goals were implemented in accordance with the protocol. Regarding the disease, participants received routine medical treatments for breast cancer.
Category
Behavior
2
Description
Control group: Routine therapies for breast cancer
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Ala' cancer prevention and control center
Full name of responsible person
Razieh Porhoseini
Street address
Ala' cancer prevention and control center., Ayatollah Saeedi Ave., Zeinabieh Blvd
City
Isfahan
Province
Isfehan
Postal code
۸۱۹۷۱۱۳۷۶۵
Phone
+98 31 3552 2006
Fax
+98 31 3552 2010
Email
info@ala.org.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University Of Khorasgan
Full name of responsible person
َAsghar Aghayi Jashoughani
Street address
East Gey Street., Arghavanieh., University Blvd
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
aghaeipsy@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University Of Khorasgan
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 Khorasgan
Full name of responsible person
Razieh Porhoseini
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
East Gey Street., Arghavanieh., University Blvd
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.porhoseini1361@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University Of Khorasgan
Full name of responsible person
Razieh Porhoseini
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
East Gey Street., Arghavanieh., University Blvd
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.porhoseini1361@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University of Khorasgan
Full name of responsible person
Razieh Porhoseini
Position
Consultant
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
East Gey Street., Arghavanieh., University Blvd
City
Isfahan
Province
Isfehan
Postal code
8155139998
Phone
+98 31 3535 4001
Email
m.porhoseini1361@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No more information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
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