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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
42

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Tugba Sahin Tokatlioglu, Phd student
  • Phone Number: +905394748707
  • Email: tugbasahin@ku.edu.tr

Study Locations

  • Turkey (Türkiye)
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Psychotherapy
IPT will be administered by the researcher who has completed the interpersonal relations psychotherapy training.
Other: PSYCHOTHERAPY
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:
  • interpersonal psychotherapy
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Koç University

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 15, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 8, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 9, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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