The purpose of this research is to determine the effectiveness of short-term solution-oriented therapy (SFBT) on reducing psychological distress and somatization disorder among breast cancer patients.
Design
The current research is conducted as a clinical trial with a control group, a blind strain, randomized using the site randomization.com on 30 patients.
Settings and conduct
The location of the research is besat Clinic in Rasht, the research method is a clinical trial with a control group, the intervention group receives 8 sessions of solution-oriented therapy, but the intervention group does not receive therapy. The research is one-sided blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria: positive screening for psychological distress and moderate or greater somatization disorder; female gender; Being in the age range of 40 to 55 years; Willingness to participate in research
Non-entry conditions: drug and alcohol abuse; Receiving all kinds of drug and psychological treatments in the last six months
Intervention groups
At the beginning of the research, the members of both experimental and control groups will be administered a pre-test questionnaire. After that, the members of the experimental group undergo intensive solution-oriented psychotherapy for 8 sessions of 90 minutes, which are performed twice a week. At the time of the intervention, the control group was put on the waiting list and did not receive any intervention. After the completion of the intervention sessions, a post-test will be conducted for both groups.
The effectiveness of short-term solution-oriented therapy (SFBT ) on psychological distress and somatization disorder in patients with breast cancer.
Public title
Effect of SFBT on psychological distress and somatization disorder in patients with breast cancer.
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
All women with breast cancer referred to Rasht oncology centers
Moderate or greater positive screening for psychological distress and somatization disorder
Exclusion criteria:
Abuse of drugs and alcohol
Receiving all kinds of drug and psychological treatments in the last six months
Age
From 40 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
Participant
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
The site http://www.randomization.com is used to divide people into two groups randomly. Due to conducting the study on two groups, the first generation random allocation method is used. The work process is that first, each of the people included in the study is assigned a number from 1 to 30. In the online software, two blocks A and B are considered active for intervention and control groups, respectively. Then the software randomly divides the numbers from 1 to 30 between two blocks of 15 people, and in this way, 15 people belong to the intervention group and 15 people belong to the active control group. For cancellation, one person outside the research team of the intervention and active control group will be randomly divided into two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
The present study is a single-blind study in which the participants in the study are blind. It should be noted that all participants are present in this study with their personal consent and knowledge of participating in the research, and this one-way blinding is only due to the reduction of error in the measurement of the outcome in the intervention and control groups.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
کمیته اخلاق دانشگاه محقق اردبیلی
Street address
University Street, Mohaghegh Ardabili University
City
Ardabil
Province
Ardabil
Postal code
5619913131
Approval date
2023-05-09, 1402/02/19
Ethics committee reference number
IR.UMA.REC.1402.002
Health conditions studied
1
Description of health condition studied
Psychological distress and somatization disorder in breast cancer patients
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Score of depression, anxiety, stress in psychological distress questionnaire DASS-21; PGQ-15 somatization questionnaire score
Timepoint
At the beginning of the study, before the start of the intervention and after the completion of the 8-session intervention period
The intervention group receives short-term solution-focused therapy (SFBT). This treatment is performed in a brief and short-term manner on subjects who are patients with breast cancer. This intervention is non-diagnostic and focuses on the patient's strengths and internal resources.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Clinic
Full name of responsible person
Fateme Najati far
Street address
Next to Tawaf Alley., Inghelab St., Rasht
City
Rasht
Province
Guilan
Postal code
4136617865
Phone
+98 13 3326 1451
Fax
+98 13 3324 6640
Email
zahraakhlaghi151@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Mahdi Moini Kia
Street address
University Street - Mohaghegh Ardabili University.
City
Ardabil
Province
Ardabil
Postal code
5619913131
Phone
+98 45 3150 5002
Fax
+98 45 3351 2200
Email
zahraakhlaghi151@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mohaghegh Ardabili University
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
Mohaghegh Ardabili University
Full name of responsible person
Zahra Akhlaghi Navideh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kochsefahan
City
Rasht
Province
Guilan
Postal code
4346136199
Phone
+98 13 1111 1111
Email
zahraakhlaghi151@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Zahra Akhlaghi Navideh
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kochsefahan
City
Rasht
Province
Guilan
Postal code
4346136169
Phone
+98 13 1111 1111
Email
zahraakhlaghi151@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mohaghegh Ardabili University
Full name of responsible person
Zahra Akhlafghi Navideh
Position
دانشجو
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Kochsefahan
City
Rasht
Province
Guilan
Postal code
4346136169
Phone
+98 13 1111 1111
Email
zahraakhlaghi151@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