Expressive Writing in Kidney Transplant Patients (EWKTP)

November 12, 2019 updated by: Carlo Lai, University of Roma La Sapienza

Effectiveness of a Psychological Intervention Focused on Expressive Writing in Patients Undergoing to Kidney Transplant

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Kidney transplantation is a replacement therapy in chronic renal failure which could allow a better quality of life. However, renal transplantation also represents an emotionally strong experience, which is associated with feelings of acceptance of the transplanted organ, change in lifestyle, side effects of pharmacotherapies, anxiety, depression, redefinition of one's body, as well as one's own social and family role. For these reasons it can be experienced as a traumatic event and be associated with an unfavorable post-operative course, in particular with regard to adherence to medical prescriptions and the consequent increase in the possibility of rejection.

Adherence, in fact, implies the correct management of drugs and the constant and assiduous presence at pre-established check-ups at the transplant center, taking the required exams and promptly reporting any complications. In kidney transplant patients, adherence to immunosuppressive therapies becomes fundamental to reduce the risk of organ rejection or, in the most extreme cases, the risk of death. Several studies show the importance of adherence to post-operative course treatment in different types of transplant. Furthermore, it has been shown that poor levels of adherence, recognized as a risk factor for organ rejection, are associated with an increase in healthcare costs.

Young age, depression, anxiety and avoidant-type adaptation strategies (eg avoiding the stressful event) are some of the risk factors of non-adherence in kidney transplant patients. Also alexithymia (known as the inability to identify and describe emotions), the inability to regulate intense emotional states, and attachment style, are associated with poor levels of post-transplant adherence.

Possemato and collaborators (2010), showed the efficacy of an intervention that uses expressive writing in the reduction of post-traumatic stress symptoms in kidney transplant patients. This technique seems to be effective also in patients with chronic pathologies and cancer, in particular in the reduction of symptoms , in the management of disease and psychophysical symptoms in cancer patients. The ways in which this technique acts are not yet clear, however it is hypothesized that the externalization and processing of traumatic events linked to the disease may favor an improvement in the ability to express emotions, and the reduction of negative thoughts and feelings associated. These studies suggest that using the technique of expressive writing in kidney transplant patients would allow them to externalize and process emotions, feelings and thoughts related to illness, transplantation and consequent changes (constant controls and therapies, sudden life style change, drug therapies and its effects, physical modifications), and this can favor a mental reorganization of negative events, a greater expression and emotions regulation, and an improvement in the interpersonal skills with family members and medical staff. Furthermore, this could be associated with a greater ability to cope with the consequences and psychophysical changes following transplantation and encourage greater levels of adherence with effects on the risk of organ rejection and health costs.

The objective of the study was to verify the effects of the expressive writing, on the post-operative course, in term of organ rejection, psychological well-being, adherence and healthcare spending in patients undergoing kidney transplantation.

Thirty-five patients were recruited at the kidney transplant center of the Policlinico Umberto I, Sapienza University of Rome. Each participant completed an informed consent form. The sample was divided into two groups in a randomized way. Of the 35 patients, 3 were excluded for not completing the task, due to logistical problems and due to the hospital situation, 1 refuse to perform the writing task, and finally 3 dropped to T2 (3rd post-transplant month). Of the remaining 28, 2 had an acute rejection before starting the writing task. The final sample is n = 26.

The study had 3 phases:

  1. Pre-operative phase (T0)

    The time of admission, just before the kidney transplant. In this phase to all participants were asked socio-demographic information and specific characteristics of the pathology in progress (eg.duration of dialysis treatment, date of transplantation, onset of disease). Then, they completed the following self-administered questionnaires:

    Beck Depression Inventory (BDI) for the evaluation of depression, State Trait Anxiety Inventory I and II (STAI Y1 - STAI Y2) for the evaluation of trait and state anxiety, Toronto Alexythymia Scale 20-item (TAS-20) for assessing the ability to identify and describe one's emotions, Interpersonal Reactivity index (IRI) for the evaluation of empathy and the Health Locus of Control for the evaluation of the patient's beliefs on his state of health and a questionnaire for the evaluation of healthcare costs, built ad hoc.

    To assess the level of adherence, each patient answered to the following question: "Have you ever forgotten to take drugs prescribed by your treatment plan? "with dichotomous answer yes / no. Finally, in order to assess the pre-transplant renal function values, such as Creatinine, CDK-EPI and azotemia were collected.

  2. Writing Phase (WP) Five days after the operation, patients belonging to the experimental group, performed the writing task related to their deepest emotions, thoughts and concerns focused on the disease and the transplant itself, for 3 consecutive days, for 20 minutes a day. They performed the writing session in a closed and silent room, which guaranteed their privacy. The instructions were according to the standard delivery by Pennebaker, creator of the technique, translated and adapted for the specific hospital situation already proposed in a study on urological patients by Solano et al. (2007). Instead, the control group performed the neutral writing task, related to the description of an object in their room, without mentioning emotions, but just describing in a neutral way what they saw, for 3 consecutive days, 20 minutes each day.
  3. The day of discharge Phase (T1) and 4) three months follow up (T2) All participants filled the questionnaire completed before the operation and they had the blood analysis according to the hospital protocol for transplanted patients.

Study Type

Interventional

Enrollment (Actual)

35

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

  • Italy
      • Roma, Italy, 00161
        • Azienda Policlinico Umberto I Sapienza University of Rome

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

18 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with major psychopathology and/or cognitive impairment

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: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Expressive Writing Group
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
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.
OTHER: Control Group
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Renal Function
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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
Time Frame: 3 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depressive symptoms
Time Frame: 3 months
In order to test any variation in depressive symptoms the BDI -II was administered at T0,T1, and T2. The Scores 0-13 indicate an absence of depressive content, the scores between 14-19 a mild depression, the scores 27-29 a moderate grade depression and the scores 30-63: a severe depression. We expected a lover level of depression in all sample, and in particular lower level (0-13) in those who performed the expressive writing task.
3 months
Anxiety
Time Frame: 3 months
In order to test any variation in anxiety level all participants completed STAI Y1, Y2 at T0, T1,T2. The scores between 80-71 represent very high level of state and trait anxiety, 70-51 represent medium-high level, 50-31 represent medium-low level and 30-20 none or very low level. We expected lower level of anxiety in all sample, but in particular lower level in those who performed the expressive writing task.
3 months
Empathy
Time Frame: 3 months
In order to test the level of empathy the IRI questionnaire was administered at T0,T1,T2. It is a multidimensional scale composed of 28 self-report items designed to measure both cognitive and emotional components of empathy. The subscale scores range from 0 to 28. We expected higher level of empathy in those who performed the expressive writing task.
3 months
Resilience
Time Frame: 3 months
In order to test the level of resilience, the CD-RISC Connor Davidson Resilience Scale was administered at T0,T1,T2. It is a self- administered questionnaire composed of 25 item and 5 subscales, with higher scores reflecting greater resilience. The score range from 0 to 100. We expected higher level of resilience in those who performed the expressive writing task.
3 months
Health Locus of control (HLC)
Time Frame: 3 months
In order to test the patient's beliefs about the state of health, the Health Locus of Control test was administered at T0,T1,T2. It is a self- administered questionnaire composed of 11 item and 2 subscales (external locus of control and internal locus of control). The score ranges from 0 to 55. We expected higher level of internal locus of control in those who performed the expressive writing task.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Roma La Sapienza

Collaborators

Azienda Policlinico Umberto I

Investigators

  • Principal Investigator: Carlo Lai, Professor, Sapienza University of Rome, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

March 1, 2018

Primary Completion (ACTUAL)

February 14, 2019

Study Completion (ACTUAL)

June 30, 2019

Study Registration Dates

First Submitted

October 25, 2019

First Submitted That Met QC Criteria

October 25, 2019

First Posted (ACTUAL)

October 29, 2019

Study Record Updates

Last Update Posted (ACTUAL)

November 14, 2019

Last Update Submitted That Met QC Criteria

November 12, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 08/2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data were collected in an excel database on the department of Dynamic and Clinical psychology laptop, protected by a password. The data are accessibile only to the Chief Investigator, the PhD student and the sub-investigator. The study protocol will be shared to other sub investigators involved in the study, but non the sensitive datas. The study report will be shared and published in a scientific journal, but the privacy of each participant will be respected according to the ethical committee established agreements.

IPD Sharing Time Frame

24 months

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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