CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 35 enrolled
Drug / intervention
Expressive Writing +1 moreother
Likely dose
Not stated in record
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Search/NCT04143178
NCT04143178N/ACompleted

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

University of Roma La Sapienza·interventional·Posted Oct 29, 2019·Updated Nov 14, 2019

In Brief

A clinical study evaluating Expressive Writing and Neutral Writing for Kidney Transplant Rejection. Completed, enrolled 35 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesItaly

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedOct 29, 2019
Enrollment StartMar 1, 2018
Primary CompletionFeb 14, 2019
Study CompletionJun 30, 2019
TodayJul 2, 2026
Enrollment to primary: 11 monthsPosted 6.7 years ago

Interventions

Expressive Writingother

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.

Neutral Writingother

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.