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

Not Applicable

Completed

• Conditions: Breast Cancer; Eye Movement Desensitization and Processing; Psychoterapy
• Interventions: Behavioral: EMDR psychotherapy

• Registration Number: NCT03271476
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-29
• Study First Submitted QC: 2017-08-31
• Study Start: 2017-09-01
• Study First Posted: 2017-09-05
• Primary Completion: 2018-07-25
• Study Completion: 2018-07-25
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-30
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Arms	EMDR psychotherapy	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)

Primary Outcome Measures

Name	Time	Method
patients involvement	week 12	acceptability of the new psychotherapy

Secondary Outcome Measures

Name	Time	Method
adequacy of the intervention with the field	Week 12	adaptability of the EMDR protocol
EMDR psychotherapy efficacy during the study, we will survey our population several times with differents questionnaires	Week 12	ratio of patients which wants to participate and effectively participate

Trial Locations

Locations (1)

CHR Metz-Thionville; 🇫🇷 Metz, France