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The Effectiveness of behavioral activation treatment on the level of depression and quality of life and psychological well-being of the family of children with Cancer

Protocol summary

Study aim
The Effectiveness of behavioral activation treatment on the level of depression, quality of life and psychological well-being of the family of children with cancer
Design
24 parents have a cancerous child and will be randomly assigned into two groups of tests and controls.
Settings and conduct
After approving the subject in the Department of Psychology and obtaining the Ethics Code from the Ethics Committee of Arsanjan University of Azad University, referring to the Anikology Hospital of Amir, 24 children with cancer have been selected and randomly divided into two groups of research, the experimental group underwent 7 sessions of behavioral activation therapy will be placed.
Participants/Inclusion and exclusion criteria
Entry requirements: Having a child with cancer in the family, the age range of children under the age of 12, having a medical record of the child suffering from a doctor, informed consent about entering the research, the absence of other medical problems, the lack of a child or parent's backwardness. ; Conditions of non-entry: one of the parents suffers from disorders such as addiction and psychotic disorders, taking psychiatric drugs, having serious suicidal thoughts, having certain medical conditions
Intervention groups
The experimental group will be trained under 7 sessions of behavioral activation therapy, weekly for 90 minutes per session, the content of each session will be formed by presenting explanations, exercises and group discussions, providing homework assignments and summing up, at the beginning At the end of the research, both research groups are evaluated by questionnaires. At the end of the research, in order to observe ethics in the research, a course of behavioral activation therapy for the control group will be implemented if this group wishes.
Main outcome variables
Depression, psychological well-being, quality of life

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20181114041659N1
Registration date: 2018-12-10, 1397/09/19
Registration timing: retrospective

Last update: 2018-12-10, 1397/09/19
Update count: 0
Registration date
2018-12-10, 1397/09/19
Registrant information
Name
Maede Ahmadzade
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 5382 2120
Email address
maedeahmadzade4@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2018-11-26, 1397/09/05
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of behavioral activation treatment on the level of depression and quality of life and psychological well-being of the family of children with Cancer
Public title
The effect of behavioral activation treatment on the family of children with cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having a child with cancer in the family The age range of children with cancer is less than 12 years old Having a doctor's medical record for a child with cancer Conscious Consent to Entering Research The absence of other medical problems Lack of child or parent backwardness
Exclusion criteria:
One of the parents is afflicted with disorders such as addiction and psychosis Taking psychiatric medications Serious suicidal thoughts Having certain medical conditions
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 24
Randomization (investigator's opinion)
Randomized
Randomization description
Randomized method: Limited randomization: This method is used if the researcher tends to have all the study groups having an equal volume. The method used between finite randomization methods is block randomization method. Block randomization method: Blocking is usually used to balance the number of specimens assigned to each of the study groups.  Random unit: Individual Random allocation cloaking: Random allocation cloaking is used in the method used to execute the random sequence on the participants in the study, so that before the assignment of the individual, the assigned group is not specified. Randomization Tool: Non-transparent sealed envelopes with random sequences
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, Arsanjan Branch
Street address
Fars, Arsanjan, University Blvd, Educational Complex, Islamic Azad University, Arsanjan Branch
City
Arsanjan
Province
Fars
Postal code
7376153161
Approval date
2018-11-14, 1397/08/23
Ethics committee reference number
IR. IAU. A. REC. 1397.002

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
P91.4
ICD-10 code description
Neonatal cerebral depression

Primary outcomes

1

Description
Depression, the score that the subject will receive in the depression, anxiety, and stress questionnaire.
Timepoint
Before the onset of behavioral activation therapy sessions, and after the end of treatment sessions, a questionnaire for depression, anxiety, stress will be provided to the control and testing group to complete.
Method of measurement
Depression, Anxiety, Stress Scale - 21questions

2

Description
Quality of Life, the score that a subject will receive on a short-term assessment of the quality of life of the World Health Organization.
Timepoint
Before the start of treatment for behavioral therapy sessions and after the end of treatment sessions, the WHO World Health Organization's Quality of Life Scale will be provided to the control and testing team to complete.
Method of measurement
The World Health Organization's Quality of Life Scale 26 questions

3

Description
Psychological well-being, the score that a subject will get in the psychological well-being psychology reef.
Timepoint
Before the onset of behavioral activation therapy sessions and after the end of treatment sessions, the psychological well-being questionnaire will be provided to the control and test group to complete.
Method of measurement
Psychological well-being questionnaire Rif 84 questions

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The intervention group will be trained on a weekly basis for up to 90 minutes per treatment session for 7 sessions of Behavioral Activation therapy by clinical psychologist trained in behavioral activation therapy. Content of each session is also formed by providing explanations, exercises and group discussions, homework assignments and summing up, and the reception of the group will also be held in the meetings. At the beginning and the end of the research, the intervention group will be evaluated by questionnaires.
Category
Treatment - Other

2

Description
Control group: The control group will not receive any psychological intervention. At the beginning and the end of the study, the control group will be evaluated by questionnaires. In order to observe the ethics in the study, a course of behavioral activation therapy should be provided to the group Will be implemented.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Amir oncology Hospital
Full name of responsible person
Samad Freidooni
Street address
Station 11, Farhang City
City
Shiraz
Province
Fars
Postal code
7187915998
Phone
+98 71 3632 3731
Email
amirhp@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Saeed Mohtashamnia
Street address
Fars, Arsanjan, University Blvd, Educational Complex, Islamic Azad University, Arsanjan Branch
City
Arsanjan
Province
Fars
Postal code
7376153161
Phone
+98 71 4352 3907
Email
Info@iaua.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Arsanjan Branch
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maede Ahmadzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Vafa alley., Valiasr avenue
City
Neyriz
Province
Fars
Postal code
7491938195
Phone
+98 71 5382 2120
Fax
Email
maedeahmadzade4@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Samad Freidooni
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Professor Mohareri neurology and psychiatry Hospital, Shiraz
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3230 5410
Email
Phdsamad2017@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Maede Ahmadzade
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Vafa Alley., Valiasr Boulevard
City
Neyriz
Province
Fars
Postal code
7491938195
Phone
+98 71 5382 2120
Email
maedeahmadzade4@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The results of the research after the completion of the research are published in a group without mention.
When the data will become available and for how long
After completing the research and publishing through the publication of the article
To whom data/document is available
The results are published collectively without mentioning names and scholars working in academic and academic institutions can access it.
Under which criteria data/document could be used
If you use the results obtained in the health system and set up a psychology unit and equip the hospitals that have cancer patients admitted to the psychology department and assist these people through experienced psychologists.
From where data/document is obtainable
Islamic Azad University, Arsanjan Branch, info@iaua.ac.ir, Maedeh Ahmadzadeh, maedeahmadzade4@gmail.com
What processes are involved for a request to access data/document
After assuring that the claimant will use the results correctly, the results will be presented to him in a group without mention.
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