NCT06546787

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 23, 2024

Completed
6 months until next milestone

First Posted

Study publicly available on registry

August 9, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

August 15, 2024

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2025

Completed
Last Updated

September 8, 2025

Status Verified

August 1, 2024

Enrollment Period

10 months

First QC Date

February 23, 2024

Last Update Submit

August 31, 2025

Conditions

Keywords

DepressionEmotion RegulationSocial SupportInterpersonal RelationshipsBreast Cancer

Outcome Measures

Primary Outcomes (3)

  • Beck Depression Screening Scale for Primary Care

    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

    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:

    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

Study Arms (2)

Psychotherapy

EXPERIMENTAL

IPT will be administered by the researcher who has completed the interpersonal relations psychotherapy training.

Other: PSYCHOTHERAPY

Observation

NO INTERVENTION

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.

Interventions

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.

Also known as: interpersonal psychotherapy
Psychotherapy

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

  • Being a pediatric oncology/hematology patient
  • Diagnosed with stage -IV breast cancer
  • Taking psychopharmacological medication
  • To have received KIPT within the last year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Koc University

Istanbul, Nursing Department, 34020, Turkey (Türkiye)

Location

MeSH Terms

Conditions

DepressionEmotional RegulationBreast Neoplasms

Interventions

PsychotherapyInterpersonal Psychotherapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorSelf-ControlSocial BehaviorNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Behavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: Randomized controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2024

First Posted

August 9, 2024

Study Start

August 15, 2024

Primary Completion

June 1, 2025

Study Completion

July 1, 2025

Last Updated

September 8, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations