Evaluating the effectiveness of compassion-Focused therapy on some psychological symptoms and improving the quality of life of cancer patients
Design
The present study will include the Men and women over 18 years of age who are referred to the Department of Chemotherapy emamkhomaini hospital and have received diagnosis any type of cancer diagnosis.he final sample will consist of 30 participants who will be randomly assigned to both control and intervention groups.
Settings and conduct
The experimental group will participate in eight sessions of 2 hours of Compassion Therapy (CFT) therapy group that will be held at Imam Khomeini Hospital in Tehran. Before and after the treatment, the members of the group were asked to give a questionnaire of compassion Self, depression, anxiety and stress, quality of life will respond, and then the compassion-based therapy will be performed for the group; The experimental group is in the intervention of this program. And the control group remain in waiting list. The total time of this study will be about one year.
Participants/Inclusion and exclusion criteria
Inclusion criteria: under chemotherapy; diagnosis of the disease for at least 3 months; women and men over 18 years of age.Exclusion criteria: psychological disorders(Psychosis, demantia)؛ Being in End stage.
Intervention groups
The intervention group will receive treatment based on Compassion-Focused Therapy. The control group does not receive any intervention and remains in the waiting list.
Main outcome variables
Reduce psychological symptoms؛ Improving the quality of life of cancer patients.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20141108019855N4
Registration date:2018-07-19, 1397/04/28
Registration timing:registered_while_recruiting
Last update:2018-07-19, 1397/04/28
Update count:0
Registration date
2018-07-19, 1397/04/28
Registrant information
Name
Samira Masumian
Name of organization / entity
Tehran Psychiatry Institue
Country
Iran (Islamic Republic of)
Phone
+98 21 3349 6990
Email address
samira.masumian@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-05-22, 1397/03/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Compassion-Focused Therapy (CFT) on psychological Sympthoms and Quality of Life on Patients with Cancer
Public title
Compassion-Focused Therapy (CFT) on Patients with Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) the age range of 18 years.
2) the possession of a minimum diploma.
3) the occurrence of any type of cancer based on a physician's diagnosis.
4) those who, according to the results of a pathological test, have at least two months The definitive history of their diagnosis passes.
5) Patients undergoing drug and chemotherapy.
Exclusion criteria:
mental retardation.
Patients are not at the end stages of cancer.
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The final sample will be included 30 participants who will be randomly assigned to both control and intervention groups. At first, the names of all the subjects will be written and be placed in a container, and in another there are 15 control sheets and 15 test sheets. Without naming the of individuals or groups, each name and group of containers are removed from each selection. This is repeated so that everyone is placed in the control and intervention groups.
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 Iran University of Medical Sciences
Street address
Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Approval date
2018-04-21, 1397/02/01
Ethics committee reference number
IR.IUMS.REC.1397.098
Health conditions studied
1
Description of health condition studied
Depression Disorder
ICD-10 code
F32.2
ICD-10 code description
Major depressive disorder, single episode, severe without psychotic features
2
Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
Depression
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
DASS inventory
2
Description
Anxiety
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
DASS inventory
3
Description
Stress
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
DASS inventory
4
Description
Compassion Focused Therapy
Timepoint
pretest.posttest (at the end of 8 session), 8 weeks following end of the treatments
Method of measurement
Self-Compassion Scale
5
Description
Quality of life
Timepoint
pretest.posttest (at the end of 8 session)
Method of measurement
Quality of life inventory
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients will participate in eight sessions of 2 hours of Group Therapy based on Compassion; at the first session, the group will respond to self-esteem, depression, anxiety and stress, and quality of life questionnaires. It will be performed for the group of compassion-based therapy; the first sessions, the rationale of compassion-based therapy, the concepts of compassion and compassion will be introduced; further, individuals are asked to try to think and behave towards themselves; During these meetings, some methods such as: picturing compassion of the species, relieving breathing, harmony, empathy, writing a compassionate letter, etc. Encouragement will be taught to the people themselves; in the final sessions, people will be encouraged to recognize and deal with factors that cause their fear and repulsion toward the component of compassion; at the last and second session Month after the end of the session (follow up), depression, anxiety, stress and quality of life will be re-tested.
Category
Treatment - Other
2
Description
Control group:The control group will not receive any psychotherapy interventions and will respond only to all the questionnaires that the testing team will answer before and after the implementation.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam Khomeini hospital
Full name of responsible person
Mahsa Mirzakhani
Street address
Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 21 6990 3349
Email
mahsa.myrzakhany@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Faculty of Behavioral Sciences of Iran University of Medical Science
Full name of responsible person
Dr Gharraee
Street address
Shahid MNo. 1, Ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City
City
Tehran
Province
Tehran
Postal code
00982133496990
Phone
+98 21 6990 3349
Email
mahsa.myrzakhany@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Faculty of Behavioral Sciences of Iran University of Medical Science
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
Iran University of Medical Sciences
Full name of responsible person
Mahsa Mirzakhani
Position
Master's Degree in Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 69903349
Email
mahsa.mirzakhani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Mirzakhani
Position
Master's Degree in Clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 69903349
Email
mahsa.mirzakhani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mahsa Mirzakhani
Position
Master's Degree in Clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Shahid MNo. 1, ansouri Street, Niyayesh Street, Satarkhan Avenue, School of Behavioral Sciences and Mental Health, Tehran City
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Phone
+98 66903349
Email
mahsa.myrzakhany@mail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is 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
Not applicable
Title and more details about the data/document
Release in clinics and mental hospitals.
When the data will become available and for how long
Get started 6 months after printing results.
To whom data/document is available
Researchers working in academia and academia.
Under which criteria data/document could be used
More research in this area for researchers with email requests.