EMDR Psychotherapy to Treat Anxious-depressive Symptoms in Breast Cancer Patient

NCT ID: NCT03271476

Last Updated: 2019-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-09-01
• Study Completion Date: 2018-07-25

Brief Summary

The study will consist in an adjustment/adaptation of the "standard EMDR protocol" for cancer disease, and most particulary for women who present a breast cancer and during adjuvant therapy. It will also test the faisability of the research, with a view to adjust the calendar and the ressources to put at disposal for a randomized control trial that follow. This study will also allow to test the need and acceptibility of this new psychotherapy for the patient, and to identify facilitators and obstacles : participation/rejection ratio, inclusion rythm, adhesion of the medical staff about the project

Conditions

Breast Cancer; Eye Movement Desensitization and Processing; Psychoterapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Arms

Experimental: EMDR psychotherapy All the women will be in this arm and thus will receive the same intervention which is : 8 sessions (1 per week). The first session is an inclusion visit at Metz-Thionville Hospital, then 6 EMDR psychotherapy sessions and finally a last visit one month after for data recovery (questionnaire and semi-directive interview)

Group Type: EXPERIMENTAL

EMDR psychotherapy

Intervention Type: BEHAVIORAL

Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient supporting Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care Visit 8 : EMDR psychotherapy care ans questionnaires Visit 9 (one month after) : semi-directive interview and data recovery (questionnaires)

Interventions

EMDR psychotherapy

Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient supporting Visit 3 : EMDR psychotherapy care Visit 4 : EMDR psychotherapy care Visit 5 : EMDR psychotherapy care and questionnaires Visit 6 : EMDR psychotherapy care Visit 7 : EMDR psychotherapy care Visit 8 : EMDR psychotherapy care ans questionnaires Visit 9 (one month after) : semi-directive interview and data recovery (questionnaires)

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Being a woman aged of 18 years or more
• Having a primary invasive breast cancer
• Having undergo a mastectomy for a primary invasive breast cancer
• Being able to complete the questionnaires
• Being informed of the study and having signed the informed consent
• Being affiliated to a welfare system

Exclusion Criteria

• having contraindications to recieve EMDR psychotherapy (neurologic disorders, dissociatif states, oculomotor issues)
• Having started adjuvant treatments following surgery
• Having metastatic breast cancer
• Presenting physical polypathologies
• Having psychiatric antecedents (included anxiety and depressif disorders - assessed with M.I.N.I. (Sheehan and al., 1997)).
• Having drug or alcohol addiction
• Being placed under the safeguard of justice, guardianship or trusteeship
• Being pregnant or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Lorraine

OTHER

Sponsor Role: collaborator

Centre Hospitalier Régional Metz-Thionville

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Rafaele Longo, Dr

Role: PRINCIPAL_INVESTIGATOR

CHR Metz-Thionville

Locations

CHR Metz-Thionville

Metz, , France

Countries

France

Other Identifiers

2017-01-CHRMT

Identifier Type: -

Identifier Source: org_study_id