Impact of Stress Management Training After Cardiac Transplantation (QUIET)

September 21, 2015 updated by: Hospices Civils de Lyon

Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.

In spite of major medical advances in heart transplant patients, psychiatric comorbidity remains very high in pre-and post-transplant phases. Anxiety and depression are especially frequent. They impact significantly morbidity and mortality. Especially because they are associated with poor therapeutic adherence and risks of infection and rejection. The inability to make beneficial therapeutic choice can be explained by the negative perception of events, associated with anxio-depressive disorders. This results in an important deterioration in quality of life of patients.

The investigators assume that better management of emotions might reduce the stress of waiting situation and its psychopathological and somatic consequences pre-and post-transplant.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 3

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

  • France
      • Bron, France, 69677
        • Recruiting
        • Service de Psychiatrie d'Adultes Liaison/Consultation,
        • Contact:
        • Principal Investigator:
          • Mohamed SAOUD, MD
      • Grenoble, France
        • Not yet recruiting
        • Pôle de Psychiatrie et de Neurologie
        • Contact:
        • Principal Investigator:
          • Thierry BOUGEROL, MD

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women on the cardiac transplantation waiting list
  • Patients aged 18 years and older
  • Signed written informed consent
  • Patients under the social security
  • Patients with a somatic condition allowing travels
  • Patients mastering the French language
  • Class II or III NYHA patients

Exclusion Criteria:

  • Patients minor or under protection measures
  • Patient who have not signed written informed consent
  • Patients not mastering the French language
  • Patients with psychiatric illness characterized by the axis 1 of DSM IV R
  • Patients receiving a psychotherapy or with a psychiatric care
  • class IV NYHA patients

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: psychotherapeutic intervention
The psychotherapeutic intervention "stress management" is based on therapeutic, behavioral and cognitive strategies. They are active and put the patient "actor" of his "adaptation" of the heart transplantation entire process. The approached components are emotional, cognitive and behavioral (techniques of communication and problem solving).
Behavioral: Stress management
Other Names:
  • The program of "stress management" will include six group sessions at a rate of one session of 2 hours every 15 days. 6 components will be approached:
  • - stress and relaxation
  • - cognitive strategies of the stress adaptation
  • - communication techniques and stress
  • - problem solving techniques and stress
  • - stress adaptation
  • - generalization of stress management in everyday situations
No Intervention: Usual medical care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients.
Time Frame: The quality of life is evaluated before the cardiac transplantation and during the 12 months after the cardiac transplantation.
The quality of life is assessed with the MLHFQ - Minnesota Living with Heart Failure Questionnaire.
The quality of life is evaluated before the cardiac transplantation and during the 12 months after the cardiac transplantation.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety manifestations pre-and post-transplant
Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Anxiety manifestations pre-and post-transplant measured with the State-Trait Anxiety Inventory
Before the cardiac transplantation and during 12 months after the cardiac transplantation
Depressive symptoms pre-and post-transplant
Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
depressive symptoms pre-and post-transplant measured using the Beck Depression Inventory (BDI-II)
Before the cardiac transplantation and during 12 months after the cardiac transplantation
Pre and post-transplant major clinical events
Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Before the cardiac transplantation and during 12 months after the cardiac transplantation
Hospitalization modalities around the graft
Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
by measuring the duration of stay in hospital, number of surgery necessary
Before the cardiac transplantation and during 12 months after the cardiac transplantation
Somatic complications after the heart transplantation
Time Frame: During 12 months after the cardiac transplantation
by measuring the mortality rate and number of graft rejection
During 12 months after the cardiac transplantation
The therapeutic adherence pre-and post-transplant
Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation
using an adherence questionnaire
Before the cardiac transplantation and during 12 months after the cardiac transplantation

Collaborators and Investigators

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

Sponsor

Hospices Civils de Lyon

Investigators

  • Principal Investigator: Mohamed SAOUD, Pr, Hospices Civils de Lyon

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

April 1, 2015

Primary Completion (Anticipated)

December 1, 2020

Study Completion (Anticipated)

December 1, 2020

Study Registration Dates

First Submitted

May 27, 2014

First Submitted That Met QC Criteria

June 12, 2014

First Posted (Estimate)

June 13, 2014

Study Record Updates

Last Update Posted (Estimate)

September 22, 2015

Last Update Submitted That Met QC Criteria

September 21, 2015

Last Verified

September 1, 2015

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2014-842

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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