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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02872324
Other study ID # 2015-30
Secondary ID 2016-A00691-50
Status Not yet recruiting
Phase N/A
First received August 16, 2016
Last updated August 16, 2016
Start date October 2016
Est. completion date October 2018

Study information

Verified date August 2016
Source Assistance Publique Hopitaux De Marseille
Contact Christophe LANCON, PUPH
Phone 0491435551
Email christophe.lançon@ap-hm.fr
Is FDA regulated No
Health authority France: Agence Nationale de Sécurité du Médicament et des produits de santé
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 66
Est. completion date October 2018
Est. primary completion date October 2018
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Other:
Procurement questionnaires


Locations

Country Name City State
France Assistance Publique Hôpitaux de Marseille Marseille

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 24 months No