Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study (MBCT)
Primary Purpose
Patients With Recurrent Depressive Disorders
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Procurement questionnaires
Sponsored by
About this trial
This is an interventional supportive care trial for Patients With Recurrent Depressive Disorders
Eligibility Criteria
Inclusion Criteria:
Major patient Patient with recurrent depression Patient have read, understood and signed the non-opposition form.
Exclusion Criteria:
Inability to understand or read English or French. Individuals unable to personally express their opposition not under whose major legal or private protection of liberty by judicial or administrative decision, or hospital emergency
Sites / Locations
- Assistance Publique Hôpitaux de Marseille
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Sessions of Mindfulness Based Cognitive Therapy (MBCT)
Arm Description
Outcomes
Primary Outcome Measures
Decrease in depression score (Beck Scale)
Decrease in depression score (Beck Scale) after the MBCT program depending on the initial level of full consciousness resource
Secondary Outcome Measures
Full Information
NCT ID
NCT02872324
First Posted
August 16, 2016
Last Updated
August 16, 2016
Sponsor
Assistance Publique Hopitaux De Marseille
1. Study Identification
Unique Protocol Identification Number
NCT02872324
Brief Title
Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study
Acronym
MBCT
Official Title
Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Assistance Publique Hopitaux De Marseille
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Mindfulness is both a natural resource of individuals present in all individuals in varying degrees characteristic ability of attention to the experience that unfolds moment by moment without judgment and a practice based on meditation, mindfulness exercises, which aims to enhance two central skills of mindfulness that are the presence and acceptanc. In the context of recurrent depression, the practice of mindfulness meditation in the frame of MBCT is recognized as effective in psychological suffering and relapse. The mechanisms implied in MBCT efficacy are emotional but especially cognitive. Among the cognitive mechanisms, reduction of rumination is a major factor in the action of MBCT, especially for patients with less than three depressive relapses.
This exploratory research focuses on the impact of mindfulness functioning (mindfulness resource level at baseline) on the benefits of MBCT for patients with recurrent depressive disorder.
The objective is to assess whether the level of mindfulness resource of patients with recurrent depression is a factor contributing to the positive effect of a MBCT applied in add-on to conventional care.
This objective will be measured by comparing the clinical improvement of patients secondary to MBCT according to the initial categorization of the mindfulness resource.
Clinical improvement will be more important for patients characterized by a lower initial level of mindfulness resource.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Patients With Recurrent Depressive Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
66 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Sessions of Mindfulness Based Cognitive Therapy (MBCT)
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Procurement questionnaires
Primary Outcome Measure Information:
Title
Decrease in depression score (Beck Scale)
Description
Decrease in depression score (Beck Scale) after the MBCT program depending on the initial level of full consciousness resource
Time Frame
24 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Major patient Patient with recurrent depression Patient have read, understood and signed the non-opposition form.
Exclusion Criteria:
Inability to understand or read English or French. Individuals unable to personally express their opposition not under whose major legal or private protection of liberty by judicial or administrative decision, or hospital emergency
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Christophe LANCON, PUPH
Phone
0491435551
Email
christophe.lançon@ap-hm.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Urielle DESALBRES, Director
Phone
0491382747
Email
drci@ap-hm.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine GEINDRE, Director
Organizational Affiliation
Assitance Publique Hôpitaux de Marseille
Official's Role
Study Director
Facility Information:
Facility Name
Assistance Publique Hôpitaux de Marseille
City
Marseille
ZIP/Postal Code
13354
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe LANCON, PUPH
Phone
0491435551
Email
christophe.lançon@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Urielle Desalbres, Director
Phone
0491382747
Email
drci@ap-hm.fr
First Name & Middle Initial & Last Name & Degree
Christophe LANCON, PUPH
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of the Impact of the Level of Mindfulness on the Management of Patients With Recurrent Depressive Disorders by the Mindfulness Based Cognitive Therapy ( MBCT ): an Exploratory Study
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