Expressive Writing in Kidney Transplant Patients

NCT04143178 | Completed DMC

• 1 other identifier: 08/2019
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Kidney transplantation is a replacement treatment for chronic renal failure that improves quality of life. However, it can be experienced as traumatic in relation to the changes it entails in terms of lifestyle, redefinition of one's body and social and family role. A negative personal experience could affect adherence to the treatment, a protective factor in reducing the risk of organ rejection and mortality. Some studies have shown the effectiveness of expressive writing in reducing the symptoms and management of the disease in patients undergoing surgery or suffering from cancer. It is hypothesized that this technique allows the processing of traumatic events linked to the disease, favoring an improvement in the expression and emotional regulation skills. The aim of the present study was to evaluate the effectiveness of a psychological intervention focused on expressive writing on the post-operative course in patients underwent to kidney transplantation. Thirty-five patients were recruited at the kidney transplant center of the Policlinico Umberto I, Rome. The sample was divided into 2 groups: the psychological intervention focused on expressive writing group and the control group which carried out a neutral writing task. Each patient filled some self-report questionnaires and carried out blood analysis, before the operation, the day of discharge and at 3 month follow-up. The psychological intervention group was expected to have a greater improvement in the emotional skills, adherence and renal function, and a lower level of healthcare costs compared to the control group.

Conditions

Kidney Transplant Rejection

Keywords

Expressive writing; Kidney transplant; Adherence; Alexithymia; Healthcare spending

Outcome Measures

Primary Outcomes (4)

• Renal Function

  In order to test the transplanted organ function the creatinine, CDK-EPI and azotemia level were measured through blood analysis at T0,T1,T2.

  3 months

• Alexithymia - difficulties in identifying, recognizing and describing emotions

  In order to evaluate the level of alexithymia the TAS-20 was administered before the operation, the day of the discharge and 3 months after the transplant. It is a self-administered questionnaire, consisting of 20 items. The scale ranges between 20 to 100 and it allows to identify alexithymic (\> 60), not alexithymic (\< 51) and probably alexithymic patients (51-60).We expect that those patients undergoing expressive writing would have a lower score (\<51) compared to control group patients.

  3 months

• Adherence

  In order to assess the level of adherence, each patient had to answer to the following question: "Have you ever forgotten to take the drugs prescribed by your treatment plan?" with dichotomous answer yes / no

  3 months

• Healthcare spending

  In order to test the healthcare spending to all participants were asked (through a specific questionnaire built ad hoc for the specific situation) the number of medical visits, the number of hospitalizations, the number of admissions to emergency room for acute episodes, the number of hospitalizations stay days in the last year, after the operation and 3 months later. The study hypothesized an lower number of medical visits, hospitalization's days and admissions to emergency room for those patients who performed the expressive writing task.

  3 months

Secondary Outcomes (5)

• Depressive symptoms

  3 months

• Anxiety

  3 months

• Empathy

  3 months

• Resilience

  3 months

• Health Locus of control (HLC)

  3 months

Study Arms (2)

Expressive Writing Group

EXPERIMENTAL

Writing group participants has been asked to write for 3 consecutive days, 20 minutes each days, all the deepest emotions and feelings related to the disease, the transplant, and their best expectations after the operation.

Other: Expressive Writing

Control Group

OTHER

The control group participant has been asked to describe an objects in their room, in a neutral way, without mentioning emotions or feelings,for 3 consecutive days, 20 minutes each day.

Other: Neutral Writing

Interventions

Expressive Writing OTHER

The expressive writing is a form of writing therapy developed primarily by James W. Pennebaker in the late 1980s consisting of writing about stressful and traumatic experience for 15-20 min for 3 consecutive days, including one's thoughts and feelings. The expressive writing allows people to express and process emotions, feelings, and thoughts related to the life events and consequent changes and this may favor a mental reorganization of the negative events, a greater expression and regulation of the emotions related to them. This intervention could provoke social, emotional, and consequently, psychophysical changes as is showed in patients with chronic diseases and cancer. In the present study, to all participants in the writing group, 5 days after the transplant, has been asked to write for 3 consecutive days, 20 minutes each days about their deepest emotions and feelings related to the chronic failure, the transplant and their expectations after that.

Expressive Writing Group

Neutral Writing OTHER

Five days after the transplant, to the control group participants has been asked to write for 3 consecutive days 20 minutes a day on an assigned neutral theme (eg. describe 1 object in the room) as objectively as possible, without mentioning their emotions or thoughts related to it.

Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients (\>18 years) of Italian nationality with sufficient level of education in order to understand the questionnaires and to carry out the writing task required by the protocol.

You may not qualify if:

• Patients with major psychopathology and/or cognitive impairment

Sponsors & Collaborators

• University of Roma La Sapienza: lead
• Azienda Policlinico Umberto I: collaborator

Study Sites (1)

Azienda Policlinico Umberto I Sapienza University of Rome

Roma, 00161, Italy

Location

Related Publications (19)

• De Pasquale C, Veroux M, Indelicato L, Sinagra N, Giaquinta A, Fornaro M, Veroux P, Pistorio ML. Psychopathological aspects of kidney transplantation: Efficacy of a multidisciplinary team. World J Transplant. 2014 Dec 24;4(4):267-75. doi: 10.5500/wjt.v4.i4.267.

  PMID: 25540735 BACKGROUND

• Calia R, Lai C, Aceto P, Luciani M, Romagnoli J, Lai S, Gargiulo A, Citterio F. Effects of switching from twice-daily to once-daily tacrolimus formulation on quality of life, anxiety, and transplant benefit perception after kidney transplantation. Transplant Proc. 2011 May;43(4):1020-3. doi: 10.1016/j.transproceed.2011.03.048.

  PMID: 21620041 BACKGROUND

• Calia R, Lai C, Aceto P, Luciani M, Camardese G, Lai S, Fantozzi C, Pietroni V, Salerno MP, Spagnoletti G, Pedroso JA, Romagnoli J, Citterio F. Emotional self-efficacy and alexithymia may affect compliance, renal function and quality of life in kidney transplant recipients: results from a preliminary cross-sectional study. Physiol Behav. 2015 Apr 1;142:152-4. doi: 10.1016/j.physbeh.2015.02.018. Epub 2015 Feb 11.

  PMID: 25680476 BACKGROUND

• Gallo I, Garrino L, Di Monte V. [The use of expressive writing in the course of care for cancer patients to reduce emotional distress: analysis of the literature]. Prof Inferm. 2015 Jan-Mar;68(1):29-36. doi: 10.7429/pi.2015.681029. Italian.

  PMID: 25837613 BACKGROUND

• Klein K, Boals A. Expressive writing can increase working memory capacity. J Exp Psychol Gen. 2001 Sep;130(3):520-33. doi: 10.1037//0096-3445.130.3.520.

  PMID: 11561925 BACKGROUND

• Lai C, Aceto P, Luciani M, Fazzari E, Cesari V, Luciano S, Fortini A, Berloco D, Canulla F, Bruzzese V, Lai S. Emotional management and biological markers of dietetic regimen in chronic kidney disease patients. Ren Fail. 2017 Nov;39(1):173-178. doi: 10.1080/0886022X.2016.1256312. Epub 2016 Nov 15.

  PMID: 27846784 BACKGROUND

• Buda B. Stephen J. Lepore & Joshua M. Smyth (Eds.) (2002). The Writing Cure: How Expressive Writing Promotes Health and Emotional Well-Being. By Bela Buda. Crisis. 2002 May;23(3):139. doi: 10.1027//0227-5910.23.3.139a. No abstract available.

  PMID: 26200669 BACKGROUND

• Fallon M, Gould D, Wainwright SP. Stress and quality of life in the renal transplant patient: a preliminary investigation. J Adv Nurs. 1997 Mar;25(3):562-70. doi: 10.1046/j.1365-2648.1997.1997025562.x.

  PMID: 9080284 BACKGROUND

• McGuire KM, Greenberg MA, Gevirtz R. Autonomic effects of expressive writing in individuals with elevated blood pressure. J Health Psychol. 2005 Mar;10(2):197-209. doi: 10.1177/1359105305049767.

  PMID: 15723890 BACKGROUND

• Gremigni P, Bacchi F, Turrini C, Cappelli G, Albertazzi A, Bitti PE. Psychological factors associated with medication adherence following renal transplantation. Clin Transplant. 2007 Nov-Dec;21(6):710-5. doi: 10.1111/j.1399-0012.2007.00727.x.

  PMID: 17988263 BACKGROUND

• Norman SA, Lumley MA, Dooley JA, Diamond MP. For whom does it work? Moderators of the effects of written emotional disclosure in a randomized trial among women with chronic pelvic pain. Psychosom Med. 2004 Mar-Apr;66(2):174-83. doi: 10.1097/01.psy.0000116979.77753.74.

  PMID: 15039501 BACKGROUND

• Pabst S, Bertram A, Zimmermann T, Schiffer M, de Zwaan M. Physician reported adherence to immunosuppressants in renal transplant patients: Prevalence, agreement, and correlates. J Psychosom Res. 2015 Nov;79(5):364-71. doi: 10.1016/j.jpsychores.2015.09.001. Epub 2015 Sep 18.

  PMID: 26526310 BACKGROUND

• Pennebaker JW, Beall SK. Confronting a traumatic event: toward an understanding of inhibition and disease. J Abnorm Psychol. 1986 Aug;95(3):274-81. doi: 10.1037//0021-843x.95.3.274. No abstract available.

  PMID: 3745650 BACKGROUND

• Pisanti R, Lombardo C, Luszczynska A, Poli L, Bennardi L, Giordanengo L, Berloco PB, Violani C. Appraisal of transplant-related stressors, coping strategies, and psychosocial adjustment following kidney transplantation. Stress Health. 2017 Oct;33(4):437-447. doi: 10.1002/smi.2727. Epub 2016 Nov 9.

  PMID: 27862894 BACKGROUND

• Prihodova L, Nagyova I, Rosenberger J, Majernikova M, Roland R, Groothoff JW, van Dijk JP. Adherence in patients in the first year after kidney transplantation and its impact on graft loss and mortality: a cross-sectional and prospective study. J Adv Nurs. 2014 Dec;70(12):2871-83. doi: 10.1111/jan.12447. Epub 2014 May 22.

  PMID: 24853863 BACKGROUND

• Rebafka A. Medication Adherence After Renal Transplantation-a Review of the Literature. J Ren Care. 2016 Dec;42(4):239-256. doi: 10.1111/jorc.12181. Epub 2016 Sep 15.

  PMID: 27629770 BACKGROUND

• Calia R, Lai C, Aceto P, Luciani M, Camardese G, Lai S, Amato G, Pietroni V, Salerno MP, Pedroso JA, Romagnoli J, Citterio F. Attachment style predict compliance, quality of life and renal function in adult patients after kidney transplant: preliminary results. Ren Fail. 2015 May;37(4):678-80. doi: 10.3109/0886022X.2015.1010989. Epub 2015 Feb 17.

  PMID: 25687387 BACKGROUND

• Smyth JM, Stone AA, Hurewitz A, Kaell A. Effects of writing about stressful experiences on symptom reduction in patients with asthma or rheumatoid arthritis: a randomized trial. JAMA. 1999 Apr 14;281(14):1304-9. doi: 10.1001/jama.281.14.1304.

  PMID: 10208146 BACKGROUND

• Solano L, Pepe L, Donati V, Persichetti S, Laudani G, Colaci A. Differential health effects of written processing of the experience of a surgical operation in high- and low-risk conditions. J Clin Psychol. 2007 Apr;63(4):357-69. doi: 10.1002/jclp.20355.

  PMID: 17279528 BACKGROUND

MeSH Terms

Conditions

Affective Symptoms

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Carlo Lai, Professor

  Sapienza University of Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: Five days after the transplant, to the expressive writing group participants has been asked to write for 3 consecutive days, for 20 minutes a day, their deepest emotions, thoughts and concerns about the disease and the transplant. They wrote in a silent room that guaranteed their privacy. The instructions followed the standard task of Pennebaker, creator of the technique (1986), translated and adapted for the specific hospital situation already proposed in a study on urological patients by Solano et al, 2007. Similarly, five days after the transplant, to the control group participants has been asked to write for 3 consecutive days 20 minutes a day on an assigned neutral theme (eg. describe 1 object in the room) as objectively as possible, without mentioning their emotions or thoughts related to it.

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: March 1, 2018
• Primary Completion: February 14, 2019
• Study Completion: June 30, 2019
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: 24 months
• Access Criteria: The sensitive data are collected in an excel database on the department of Dynamic and Clinical psychology laptop, protected by a password. Each participant is identified by a personal numerical code, to guarantee them their privacy. All the sensitive data will be accessible only by the Chief investigator, the PhD student and the sub-investigator co-responsible of the study.

Locations

IT (1)