EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

Not Applicable

Completed

• Conditions: Breast Cancer Female
• Interventions: Behavioral: EMDR psychotherapy; Behavioral: support psychotherapy

• Registration Number: NCT03898453
• Lead Sponsor: Centre Hospitalier Régional Metz-Thionville

Brief Summary

The study will consist in an evaluation of the EMDR (Eye Movement Desensitization and Reprocessing) psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score (CES-D) and PTSD score, and a higher increase in quality of life.

Detailed Description

The study will consist in an evaluation of the EMDR psychotherapy in the context on invasive primitive breast cancer. EMDR could then allow the affected patients to readjust their point of view on the pathology and thus promote more adapted behaviors or additional resources to cope with the disease. 190 Patients are going to be randomized in two groups : one group with EMDR psychotherapists and one group with support psychotherapists. Patients will receive 8 sessions. We expect that patient in EMDR psychotherapists group will have an higher decrease of anxiety score, depressive score and PTSD score, and a higher increase in quality of life (QLQ)

Study Timeline

• Study First Submitted: 2019-01-30
• Study Start: 2019-03-11
• Study First Submitted QC: 2019-03-29
• Study First Posted: 2019-04-02
• Status Verified: 2022-09
• Primary Completion: 2023-09-24
• Study Completion: 2023-09-24
• Last Update Submitted: 2023-10-19
• Last Update Posted: 2023-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

• Being a 18 or more year old woman
• Having primary breast cancer or going to start treatment or having completed treatments for less than 6 months
• Presenting a state-anxiety level a score higher than 35.
• Being able to complete questionnaires.
• Having signed the consent letter
• Be affiliated to a social security system

Exclusion Criteria

• Have contraindications for EMDR psychotherapy (neurological disorders, dissociative states, oculomotor problems)
• Have metastatic breast cancer
• physical multiple pathologies
• Have a psychiatric history (including anxio-depressive disorders). Background Assessment from M.I.N.I. (Sheehan et al., 1997)
• Present an addiction, an abuse of drugs or alcohol
• Person placed under the protection of justice, guardianship or trusteeship.
• Pregnant or lactating woman

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group EMDR psychotherapy	EMDR psychotherapy	Visit 0 : patient inclusion (questionnaires and interview) Visit 1 : anamnesis Visit 2 : patient stabilisation 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 and questionnaires Follow-up 8 (three month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)
Group Control : support psychotherapy	support psychotherapy	Visit 0 : patient inclusion (questionnaires and interview) Visits 1-7: several methods could be used: psychoeducation about cancer and psychotherapy, positive interaction and activity schedule, emotional support , relaxation, prevention techniques... Questionnaires will be completed by patients at visit 5 and 7. Follow-up 8 (one month after) : data recovery (questionnaires) Follow-up 9 (six month after) : data recovery (questionnaires)

Primary Outcome Measures

Name	Time	Method
State Anxiety	Month 9	STAI-Y-A (State-Trait Anxiety Inventory) This questionnaire consists of a 20-items. The state version (STAI Y-A) indicate for 20 items and on 4-point Likert-Scale (not at all, somewhat, moderately so, and very much so) the extent to which they are currently experiencing each symptoms of anxiety. The total score ranges from 20 to 80. A higher total score indicate a higher level of anxiety.

Secondary Outcome Measures

Name	Time	Method
depression	Month 9	CES-D (The Center for Epidemiologic Studies Depression) Questionnaire
posttraumatic symptoms	Month 9	PTGI (The Posttraumatic Growth Inventory) Questionnaire
quality of life of cancer patients	Month 9	EORTC QLQ-C30 Questionnaire The European Organization for research and Treatment of Cancer 30-item Quality of life (QoL) questionnaire is a well-validated health-related QoL instrument.

Trial Locations

Locations (1)

CHR Metz-Thionville; 🇫🇷 Metz, France