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The Effectiveness of Existential-Humanistic Therapy on Psychological Well-being, Self-acceptance and Post-traumatic Growth in the Women with Breast Cancer and their Spouses' Marital Satisfaction

Protocol summary

Study aim
The Effectiveness of Existential-Humanistic Therapy on Psychological Well-being, Self-acceptance and Post-traumatic Growth in the Women with Breast Cancer and their Spouses' Marital Satisfaction
Design
Sampling method: The statistical population includes all the women suffering from breast cancer with medical records in Shahid Rahimi hospital in Khorramabad, Iran. Observing the inclusion and exclusion criteria, 30 individuals ready to cooperate will be selected and non-randomly divided into two experimental and control groups (15 individuals in each group). Simultaneously, pre-test, post-test, and follow-up will be performed on their spouses.
Settings and conduct
In the similar and simultaneous condition, the pre-test is conducted in the form of Psychological Well-Being (PWB) Scale, post-traumatic growth, and self-acceptance for both experimental and control groups, and Marital Satisfaction Questionnaire is administered to the spouses of both groups. Then, intervention is performed as virtual treatment on the experimental group in 8 sessions of 90 minutes.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Suffering from breast cancer, breast tissue surgery, having at least a diploma degree. Exclusion criteria: any severe psychiatric illness
Intervention groups
The intervention group: The women with breast cancer in Khorramabad, Iran, who underwent Krug-Scheneider's (2008) Existential-Humanistic Therapy. The control group received no intervention.
Main outcome variables
psychological well-being; self-acceptance; post-traumatic growth; marital satisfaction.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201219049767N1
Registration date: 2021-01-25, 1399/11/06
Registration timing: retrospective

Last update: 2021-01-25, 1399/11/06
Update count: 0
Registration date
2021-01-25, 1399/11/06
Registrant information
Name
Safoora Mavaeeyan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3832 0643
Email address
mavaeeyan.sa@fh.lu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-09-28, 1399/07/07
Expected recruitment end date
2020-10-18, 1399/07/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Existential-Humanistic Therapy on Psychological Well-being, Self-acceptance and Post-traumatic Growth in the Women with Breast Cancer and their Spouses' Marital Satisfaction
Public title
The Effectiveness of Existential-Humanistic Therapy on Psychological Well-being, Self-acceptance and Post-traumatic Growth in the Women with Breast Cancer and their Spouses' Marital Satisfaction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Suffering from breast cancer Breast tissue surgery Having at least a diploma degree Being satisfied to participate in this project
Exclusion criteria:
Suffering from severe medical psychiatric disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Not randomized
Randomization description
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 Lorestan University of Medical Sciences
Street address
No. 4, 8th Alley, 2nd Square, Kayhanshahr Town
City
Kermanshah
Province
Kermanshah
Postal code
6715694884
Approval date
2020-09-27, 1399/07/06
Ethics committee reference number
IR.LUMS.REC.1399.177

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
The score of Ryff's Psychological Well-being (PWB) Scale (1989)
Timepoint
Pre-test, post-test, and a two-month follow-up period
Method of measurement
Ryff's 18-Item Psychological Well-being Scale (1989)

2

Description
Self-acceptance
Timepoint
Pre-test, post-test, and a two-month follow-up period
Method of measurement
Chamberlain and Haaga's (2001) Unconditional Self-Acceptance Questionnaire (USAQ)

3

Description
Post-traumatic growth; the score that the participants obtain from Tedeschi and Calhoun's (1996) Post-Traumatic Growth Inventory (PTGI)
Timepoint
Pre-test, post-test, and a two-month follow-up period
Method of measurement
Tedeschi and Calhoun's (1996) Post-Traumatic Growth Inventory (PTGI)

4

Description
Marital satisfaction
Timepoint
Pre-test, post-test, and a two-month follow-up period
Method of measurement
ENRICH 35-Item Marital Satisfaction Inventory (1989)

Secondary outcomes

empty

Intervention groups

1

Description
The intervention group: The patients are treated in 8 sessions of 90 minutes using Krug-Schneider's (2008) Existential-Humanistic Therapy .
Category
Treatment - Other

2

Description
The Control group: They receive no intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Shahid Rahimi Hospital, Khorramabad
Full name of responsible person
Safoora Mavaeeyan
Street address
No. 4, 8th Alley, 2nd Square, Kayhanshahr Town
City
Kermanshah
Province
Kermanshah
Postal code
6715694884
Phone
+98 83 3832 0643
Email
safooramavaeeyan1366@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Safoora Mavaeeyan
Street address
No. 4, 8th Alley, 2nd Square, Kayhanshahr Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715694884
Phone
+98 83 3832 0643
Email
safooramavaeeyan1366@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Lorestan University of Medical Sciences
Proportion provided by this source
1
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
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Safoora Mavaeeyan
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, 8th Alley, 2nd Square, Kayhanshahr Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715694884
Phone
+98 83 3832 0643
Email
safooramavaeeyan1366@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Safoora Mavaeeyan
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, 8th Alley, 2nd Square, Kayhanshahr Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715694884
Phone
0098 83 8320643
Email
safooramavaeetan1366@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Khoram-Abad University of Medical Sciences
Full name of responsible person
Safoora Mavaeeyan
Position
University student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
No. 4, 8th Alley, 2nd Square, Kayhanshahr Town, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715694884
Phone
+98 83 3832 0643
Email
safooramavaeeyan1366@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
At the end of the study, the data for the participants (without mentioning their names) and the results of their analysis and the statistical methods used in the study , along with the protocol, are all provided to other people.
When the data will become available and for how long
The article is accessed one month after its publication.
To whom data/document is available
Everyone can have access to the data.
Under which criteria data/document could be used
Individuals can use the data for therapeutic and research use.
From where data/document is obtainable
safooramavaeeyan1366@gmail.com , Recipient: Safoura Mavaeian, Contact No.: +989388815843
What processes are involved for a request to access data/document
The researcher contacts via the said communication methods, and receives the information via email within a maximum of one month.
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