NCT06839287

Brief Summary

The aim of this clinical study is to examine the effect of interpersonal psychotherapy-based counseling on adjustment to illness and depression levels in individuals receiving hemodialysis treatment. The main questions this study aims to answer are: Does interpersonal psychotherapy-based counseling improve the adjustment to illness in individuals receiving hemodialysis treatment? Does interpersonal psychotherapy-based counseling reduce depressive symptoms in individuals receiving hemodialysis treatment? The researchers will compare interpersonal psychotherapy-based counseling with routine care to determine its effectiveness in individuals undergoing hemodialysis treatment. Participants: For eight weeks, participants will receive either routine care or interpersonal psychotherapy-based counseling.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 17, 2025

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
8 days until next milestone

Study Start

First participant enrolled

March 1, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 5, 2025

Completed
Last Updated

September 17, 2025

Status Verified

February 1, 2025

Enrollment Period

4 months

First QC Date

February 17, 2025

Last Update Submit

September 16, 2025

Conditions

Keywords

hemodialysis patientsdepressionadjusment to illnessinterpersonal psychotherapycounselingnursing

Outcome Measures

Primary Outcomes (1)

  • Adaptation to Chronic Diseases Scale

    The Adaptation to Chronic Diseases Scale was developed by Atik and Karatepe (2016) to assess the level of adaptation to the disease of individuals diagnosed with chronic diseases (heart, lung and kidney diseases, diabetes, etc.). In the scale, situations including beliefs, attitudes and behaviors experienced by individuals diagnosed with chronic diseases during the disease are specified. The scale consists of 5-point Likert type and 25 items (56). The scale has 3 sub-dimensions as Physical, Social and Psychological Adjustment. Physical Adjustment sub-dimension consists of 1st, 9th, 10th, 13th, 16th, 18th, 22-24th items, Social Adjustment sub-dimension consists of 2nd, 3rd, 5th, 7th, 17th, 19th and 25th items, Psychological Adjustment sub-dimension consists of 4th, 6th, 8th, 11th, 12th, 20th and 21st items. A maximum score of 55 and a minimum score of 11 can be obtained from the Physical Adjustment sub-dimension, a maximum score of 35 and a minimum score of 7 from the Social Adjustment

    five mounths

Secondary Outcomes (1)

  • Beck Depression Scale

    five mounths

Study Arms (2)

IPT Group

EXPERIMENTAL

Interpersonal psychotherapy-based counseling will be applied to indivuduals with receiving hemodialysis for 8 weeks

Other: Interpersonal psychotherapy-based counseling

Control Group

NO INTERVENTION

Participants in this group will receive routine care

Interventions

The first data from the individuals in the experimental and control groups will be collected after the first interview. Data will be collected from the individuals to whom interpersonal relationship therapy techniques are applied after the 8th session by face-to-face interviews. In addition, if the individuals in the experimental group have questions about psychotherapy, they will be answered. The control group will be verbally informed with the data collection form and chronic disease adaptation and depression scales and will continue to receive routine care. Data will be collected by face-to-face interviews with the control group after the first interview and 8 weeks later when they come to the dialysis center. Follow-up data of the participants will be collected again at the 3rd month after the last interview.

IPT Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 18 years of age or older,
  • Hemodialysis treatment for at least 6 months,
  • Having no problem communicating in Turkish,
  • No hearing problems and cognitive impairment,
  • Openness to cooperation,
  • Not diagnosed with major depression according to DSM-V and ICD-11,
  • Not having an additional mental disorder,
  • Not receiving any therapy or treatment,
  • Receiving hemodialysis treatment at the center 3 days a week,
  • Do not take care of yourself,
  • Scoring 10 and above on the Beck Depression Inventory (scores of 10 and above indicate that the participant has depressive symptoms)
  • Patients who voluntarily agree to participate in the study will be included.

You may not qualify if:

  • \- Having a neurological or psychiatric illness that may interfere with reading and understanding the data collection tools,
  • Have received or are receiving any therapy or treatment,
  • A score of 10 or less on the Beck Depression Inventory,
  • Having problems in speaking/understanding Turkish,
  • Changing cities during research,
  • Don't want to leave the research,
  • Receiving a psychiatric diagnosis during research,
  • Starting therapy or treatment during the research,
  • Hospitalization during research,
  • Failure to attend the treatment for 2 consecutive sessions,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Başkent University

Ankara, Turkey (Türkiye)

Location

Related Publications (22)

  • Stuart S, Schultz J, Molina AP, Siber-Sanderowitz S. Interpersonal Psychotherapy: A Review of Theory, History, and Evidence of Efficacy. Psychodyn Psychiatry. 2024 Sep;52(3):370-407. doi: 10.1521/pdps.2024.52.3.370.

    PMID: 39254940BACKGROUND
  • Summers KM, Martin KE, Watson K. Impact and clinical management of depression in patients with coronary artery disease. Pharmacotherapy. 2010 Mar;30(3):304-22. doi: 10.1592/phco.30.3.304.

    PMID: 20180613BACKGROUND
  • Xu H, Koszycki D. Interpersonal Psychotherapy for Late-life Depression and its Potential Application in China. Neuropsychiatr Dis Treat. 2020 Aug 7;16:1919-1928. doi: 10.2147/NDT.S248027. eCollection 2020.

    PMID: 32821108BACKGROUND
  • Karam AM, Fitzsimmons-Craft EE, Tanofsky-Kraff M, Wilfley DE. Interpersonal Psychotherapy and the Treatment of Eating Disorders. Psychiatr Clin North Am. 2019 Jun;42(2):205-218. doi: 10.1016/j.psc.2019.01.003.

    PMID: 31046923BACKGROUND
  • Cuijpers P, Donker T, Weissman MM, Ravitz P, Cristea IA. Interpersonal Psychotherapy for Mental Health Problems: A Comprehensive Meta-Analysis. Am J Psychiatry. 2016 Jul 1;173(7):680-7. doi: 10.1176/appi.ajp.2015.15091141. Epub 2016 Apr 1.

    PMID: 27032627BACKGROUND
  • Ravitz P, Watson P, Lawson A, Constantino MJ, Bernecker S, Park J, Swartz HA. Interpersonal Psychotherapy: A Scoping Review and Historical Perspective (1974-2017). Harv Rev Psychiatry. 2019 May/Jun;27(3):165-180. doi: 10.1097/HRP.0000000000000219.

    PMID: 30883446BACKGROUND
  • Pu J, Zhou X, Liu L, Zhang Y, Yang L, Yuan S, Zhang H, Han Y, Zou D, Xie P. Efficacy and acceptability of interpersonal psychotherapy for depression in adolescents: A meta-analysis of randomized controlled trials. Psychiatry Res. 2017 Jul;253:226-232. doi: 10.1016/j.psychres.2017.03.023. Epub 2017 Mar 16.

    PMID: 28391140BACKGROUND
  • Poleshuck EL, Talbot NE, Zlotnick C, Gamble SA, Liu X, Tu X, Giles DE. Interpersonal psychotherapy for women with comorbid depression and chronic pain. J Nerv Ment Dis. 2010 Aug;198(8):597-600. doi: 10.1097/NMD.0b013e3181ea4d3d.

    PMID: 20699727BACKGROUND
  • Palmer S, Vecchio M, Craig JC, Tonelli M, Johnson DW, Nicolucci A, Pellegrini F, Saglimbene V, Logroscino G, Fishbane S, Strippoli GF. Prevalence of depression in chronic kidney disease: systematic review and meta-analysis of observational studies. Kidney Int. 2013 Jul;84(1):179-91. doi: 10.1038/ki.2013.77. Epub 2013 Mar 13.

    PMID: 23486521BACKGROUND
  • Tian N, Chen N, Li PK. Depression in dialysis. Curr Opin Nephrol Hypertens. 2021 Nov 1;30(6):600-612. doi: 10.1097/MNH.0000000000000741.

    PMID: 34456238BACKGROUND
  • Gerogianni G, Kouzoupis A, Grapsa E. A holistic approach to factors affecting depression in haemodialysis patients. Int Urol Nephrol. 2018 Aug;50(8):1467-1476. doi: 10.1007/s11255-018-1891-0. Epub 2018 May 19.

    PMID: 29779116BACKGROUND
  • Frasure-Smith N, Koszycki D, Swenson JR, Baker B, van Zyl LT, Laliberte MA, Abramson BL, Lambert J, Gravel G, Lesperance F. Design and rationale for a randomized, controlled trial of interpersonal psychotherapy and citalopram for depression in coronary artery disease (CREATE). Psychosom Med. 2006 Jan-Feb;68(1):87-93. doi: 10.1097/01.psy.0000195833.68482.27.

    PMID: 16449416BACKGROUND
  • Belay W, Kaba M, Labisso WL, Tigeneh W, Sahile Z, Zergaw A, Ejigu A, Baheretibeb Y, Gufue ZH, Haileselassie W. The effect of interpersonal psychotherapy on quality of life among breast cancer patients with common mental health disorder: a randomized control trial at Tikur Anbessa Specialized Hospital. Support Care Cancer. 2022 Jan;30(1):965-972. doi: 10.1007/s00520-021-06508-y. Epub 2021 Aug 25.

    PMID: 34432169BACKGROUND
  • Yator O, Kagoya M, Khasakhala L, John-Stewart G, Kumar M. Task-sharing and piloting WHO group interpersonal psychotherapy (IPT-G) for adolescent mothers living with HIV in Nairobi primary health care centers: a process paper. AIDS Care. 2021 Jul;33(7):873-878. doi: 10.1080/09540121.2020.1801981. Epub 2020 Aug 11.

    PMID: 32781831BACKGROUND
  • Hedayati SS, Bosworth HB, Kuchibhatla M, Kimmel PL, Szczech LA. The predictive value of self-report scales compared with physician diagnosis of depression in hemodialysis patients. Kidney Int. 2006 May;69(9):1662-8. doi: 10.1038/sj.ki.5000308.

    PMID: 16598203BACKGROUND
  • Çınar, S. (2009). Hemodiyaliz hastalarında psikososyal uyum ve etkileyen faktörlerin belirlenmesi. Nefroloji Hemşireliği Dergisi, 6(1-2), 22-28.

    BACKGROUND
  • Davison SN. Personalized Approach and Precision Medicine in Supportive and End-of-Life Care for Patients With Advanced and End-Stage Kidney Disease. Semin Nephrol. 2018 Jul;38(4):336-345. doi: 10.1016/j.semnephrol.2018.05.004.

    PMID: 30082054BACKGROUND
  • Schulman-Green D, Jaser S, Martin F, Alonzo A, Grey M, McCorkle R, Redeker NS, Reynolds N, Whittemore R. Processes of self-management in chronic illness. J Nurs Scholarsh. 2012 Jun;44(2):136-44. doi: 10.1111/j.1547-5069.2012.01444.x. Epub 2012 May 2.

    PMID: 22551013BACKGROUND
  • Kacaroglu Vicdan A, Gulseven Karabacak B. Effect of Treatment Education Based on the Roy Adaptation Model on Adjustment of Hemodialysis Patients. Clin Nurse Spec. 2016 Jul-Aug;30(4):E1-E13. doi: 10.1097/NUR.0000000000000215.

    PMID: 27309790BACKGROUND
  • Webster AC, Nagler EV, Morton RL, Masson P. Chronic Kidney Disease. Lancet. 2017 Mar 25;389(10075):1238-1252. doi: 10.1016/S0140-6736(16)32064-5. Epub 2016 Nov 23.

    PMID: 27887750BACKGROUND
  • Romagnani P, Remuzzi G, Glassock R, Levin A, Jager KJ, Tonelli M, Massy Z, Wanner C, Anders HJ. Chronic kidney disease. Nat Rev Dis Primers. 2017 Nov 23;3:17088. doi: 10.1038/nrdp.2017.88.

    PMID: 29168475BACKGROUND
  • Kalantar-Zadeh K, Jafar TH, Nitsch D, Neuen BL, Perkovic V. Chronic kidney disease. Lancet. 2021 Aug 28;398(10302):786-802. doi: 10.1016/S0140-6736(21)00519-5. Epub 2021 Jun 24.

    PMID: 34175022BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
In this study, participants will be randomly assigned to intervention and control groups. As a blinding method, it will be arranged so that the participants and the people responsible for data analysis who will make the evaluations will not know which group the participants are in (single-blind or double-blind design). Participants may know their groups due to the intervention content, but evaluations will be made with objective scales so as not to affect the study results.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: In this study, there are two groups. One of them is interventional group which participants receiving IPT for 8 weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

February 17, 2025

First Posted

February 21, 2025

Study Start

March 1, 2025

Primary Completion

July 1, 2025

Study Completion

September 5, 2025

Last Updated

September 17, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations