- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06546787
The Effect of Interpersonal Relationships Psychotherapy on Breast Cancer Patients
August 31, 2025 updated by: Koç University
The Effect of Interpersonal Relationships Psychotherapy on Depression, Emotion Regulation and Social Support Levels in Breast Cancer Patients With Depression Risk: A Randomized Controlled Study
This study is planned to examine the effect of Interpersonal Relationship Psychotherapy on depression, interpersonal emotion regulation and multidimensional perceived social support levels of breast cancer patients with depression risk.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
There are not enough studies showing the effect of IPT, which is an evidence-based psychotherapy that works on problem areas such as role change that may occur with the disease and provides support for recognizing and using social support mechanisms, on cancer patients.
This study is thought to make a significant contribution to the literature, especially in terms of making family support, which has an important place in social support systems, available to patients, intervening in interpersonal emotion regulation problems that may occur in patients and affecting depression levels.
Study Type
Interventional
Enrollment (Actual)
42
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Nursing Department
-
Istanbul, Nursing Department, Turkey (Türkiye), 34020
- Koc University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Includes Criteria
- Ability to communicate in Turkish
- Diagnosed with Stage-II and Stage-III breast cancer
- Continuing outpatient treatment
- Four points on the Primary Care Depression Screening Scale
- Internet connection
- Has a phone that can use the zoom app to continue conversations to be
- To be able to use the Zoom app
Exclusion Criteria
- Being a pediatric oncology/hematology patient
- Diagnosed with stage -IV breast cancer
- Taking psychopharmacological medication
- To have received KIPT within the last year
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Psychotherapy
IPT will be administered by the researcher who has completed the interpersonal relations psychotherapy training.
|
IPT, was prepared by the researcher who completed the interpersonal relations psychotherapy training.The first interview will be conducted face-to-face in the offices of Koç University Faculty of Nursing.
Subsequent sessions will be conducted via Zoom according to the availability of the patients included in the study.
The day and time of the interviews will be planned according to the availability of the patients before the interviews.
A total of 12 interviews are planned to be conducted with a patient for 40-60 minutes each.
Interview intervals will be organized as once a week.
Other Names:
|
|
No Intervention: Observation
Patients in the control group will be asked to complete the post-tests at the same time after the experimental group interviews are completed.
However, no intervention will be made to the control group.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck Depression Screening Scale for Primary Care
Time Frame: Through study completion, an average of 6 months
|
Each question has four answers.
The lowest possible score is zero and the highest possible score is three.
A total maximum score of 21 and a minimum score of zero can be achieved.
Depression scores of breast cancer patients are expected to decrease after treatment.
It is expected to fall below 4 points.
|
Through study completion, an average of 6 months
|
|
Interpersonal relationships emotion regulation scale
Time Frame: Through study completion, an average of 6 months
|
The highest score that can be obtained from the scale is 100 and the lowest score is 20.
The high score obtained from each sub-dimension of the scale indicates that the individual has the characteristic evaluated by the relevant sub-dimension.
Scores obtained from the scale were found to be related to the total score of the Difficulties in Emotion Regulation Scale and also to depression and anxiety.An increase in the interpersonal relations emotion regulation scale score is expected in breast cancer patients after treatment.
This increase shows that it has a positive effect on individuals' emotion regulation.
|
Through study completion, an average of 6 months
|
|
Multidimensional Perceived Social Support Scale:
Time Frame: Through study completion, an average of 6 months
|
The lowest score that can be obtained from the scale is "12" and the highest score is "84".
An increase in the total score of the scale means an increase in the level of perceived social support.
Social support scores of breast cancer patients are expected to increase after treatment.
|
Through study completion, an average of 6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 15, 2024
Primary Completion (Actual)
June 1, 2025
Study Completion (Actual)
July 1, 2025
Study Registration Dates
First Submitted
February 23, 2024
First Submitted That Met QC Criteria
August 8, 2024
First Posted (Actual)
August 9, 2024
Study Record Updates
Last Update Posted (Estimated)
September 8, 2025
Last Update Submitted That Met QC Criteria
August 31, 2025
Last Verified
August 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0036315
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.