Heart TransplantPhase 3QUIETNCT02163629
Impact of Stress Management Training After Cardiac Transplantation
A Phase 3 study testing Stress management in people with Heart Transplant, run by Hospices Civils de Lyon at 2 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant
- What is being tested?
- Stress management
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Apr 2015to Dec 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Mohamed SAOUD, Pr contact
France2 sites, 2 recruiting
- Recruiting
Service de Psychiatrie d'Adultes Liaison/Consultation,
Bron, 69677
Mohamed SAOUD, PR, 4 72 11 80 64 ext. +33, mohamed.saoud@chu-lyon.fr
Mohamed SAOUD, MD
- Not yet recruiting
Pôle de Psychiatrie et de Neurologie
Grenoble
Thierry BOUGEROL, MD, tbougerol@chu-grenoble.fr
Thierry BOUGEROL, MD
About this study
Official title: 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.
- Conditions
- Heart Transplant
- Being tested
- Stress management
- Keywords
- Psychotherapeutic intervention, stress management, cardiac transplantation, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stress managementBehavioural
Also called 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
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: Behavioral: Stress management |
| Usual medical care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Anxiety manifestations pre-and post-transplant measured with the State-Trait Anxiety Inventory
Measured: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Depressive symptoms pre-and post-transplant
depressive symptoms pre-and post-transplant measured using the Beck Depression Inventory (BDI-II)
Measured: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Pre and post-transplant major clinical events
Measured: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Hospitalization modalities around the graft
by measuring the duration of stay in hospital, number of surgery necessary
Measured: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Somatic complications after the heart transplantation
by measuring the mortality rate and number of graft rejection
Measured: During 12 months after the cardiac transplantation
The therapeutic adherence pre-and post-transplant
using an adherence questionnaire
Measured: Before the cardiac transplantation and during 12 months after the cardiac transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2014 (estimated)
- Study startApr 2015
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart TransplantStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohamed SAOUD, Pr, Principal investigator, Hospices Civils de Lyon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02163629
- Sponsor's protocol ID
- 2014-842
- Acronym
- QUIET
- Status last verified
- Sep 2015
- First submitted
- 27 May 2014
- Last updated
- 22 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Stress Management Training on Quality of Life and Cardiac Post-transplantation Complications in a Controlled Multicentric Comparative Study.
- ClinicalTrials.gov ID
- NCT02163629
- Acronym / sponsor ID
- QUIET / 2014-842
- Conditions
- Heart Transplant
- Keywords
- Psychotherapeutic intervention, stress management, cardiac transplantation, quality of life
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Apr 2015
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 13 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychotherapeutic intervention | Experimental | Behavioral: Stress managementThe 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). |
| Usual medical care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stress managementAlso: 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 | Behavioural | psychotherapeutic intervention |
Primary outcome
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.
6 secondary outcomes
Anxiety manifestations pre-and post-transplant
Time frame: 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
Pre and post-transplant major clinical events
Time frame: 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
Somatic complications after the heart transplantation
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohamed SAOUD, Pr contact
Mohamed SAOUD, Pr principal investigator
Hospices Civils de Lyon
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Stress management in people with Heart Transplant, run by Hospices Civils de Lyon at 2 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamed SAOUD, Pr (mohamed.saoud@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2015.