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Impact of Stress Management Training After Cardiac Transplantation (QUIET)

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ClinicalTrials.gov Identifier: NCT02163629
Recruitment Status : Recruiting
First Posted : June 13, 2014
Last Update Posted : September 22, 2015
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Heart Transplant Behavioral: Stress management Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.
Study Start Date : April 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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

  2. 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)

  3. Pre and post-transplant major clinical events [ Time Frame: Before the cardiac transplantation and during 12 months after the cardiac transplantation ]
  4. 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

  5. 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

  6. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163629


Contacts
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Contact: Mohamed SAOUD, Pr mohamed.saoud@chu-lyon.fr

Locations
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France
Service de Psychiatrie d'Adultes Liaison/Consultation, Recruiting
Bron, France, 69677
Contact: Mohamed SAOUD, PR    4 72 11 80 64 ext +33    mohamed.saoud@chu-lyon.fr   
Principal Investigator: Mohamed SAOUD, MD         
Pôle de Psychiatrie et de Neurologie Not yet recruiting
Grenoble, France
Contact: Thierry BOUGEROL, MD       tbougerol@chu-grenoble.fr   
Principal Investigator: Thierry BOUGEROL, MD         
Sponsors and Collaborators
Hospices Civils de Lyon
Investigators
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Principal Investigator: Mohamed SAOUD, Pr Hospices Civils de Lyon
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT02163629    
Other Study ID Numbers: 2014-842
First Posted: June 13, 2014    Key Record Dates
Last Update Posted: September 22, 2015
Last Verified: September 2015
Keywords provided by Hospices Civils de Lyon:
Psychotherapeutic intervention
stress management
cardiac transplantation
quality of life