Impact of Stress Management Training After Cardiac Transplantation

NCT02163629 | Unknown Phase 3

• 1 other identifier: 2014-842
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

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.

Conditions

Heart Transplant

Keywords

Psychotherapeutic intervention; stress management; cardiac transplantation; quality of life

Outcome Measures

Primary Outcomes (1)

• Evaluation of the impact of a psychotherapeutic intervention on the quality of life of cardiac transplant patients.

  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 Outcomes (6)

• Anxiety manifestations pre-and post-transplant

  Before the cardiac transplantation and during 12 months after the cardiac transplantation

• Depressive symptoms pre-and post-transplant

  Before the cardiac transplantation and during 12 months after the cardiac transplantation

• Pre and post-transplant major clinical events

  Before the cardiac transplantation and during 12 months after the cardiac transplantation

• Hospitalization modalities around the graft

  Before the cardiac transplantation and during 12 months after the cardiac transplantation

• Somatic complications after the heart transplantation

  During 12 months after the cardiac transplantation

Study Arms (2)

psychotherapeutic intervention

EXPERIMENTAL

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

Usual medical care

NO INTERVENTION

Interventions

Stress management BEHAVIORAL

Also known as: 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

psychotherapeutic intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (2)

Service de Psychiatrie d'Adultes Liaison/Consultation,

Bron, 69677, France

RECRUITING

Pôle de Psychiatrie et de Neurologie

Grenoble, France

NOT YET RECRUITING

Study Officials

• Mohamed SAOUD, Pr

  Hospices Civils de Lyon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohamed SAOUD, Pr

CONTACT

mohamed.saoud@chu-lyon.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 27, 2014
• First Posted: June 13, 2014
• Study Start: April 1, 2015
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: September 22, 2015

Record last verified: 2015-09

Locations

FR (2)