Clinical trial NCT03898453: EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient
Official title: EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer Female
Keywords: Breast Cancer
support psychotherapy
EMDR therapy
anxiety disorders
Lead sponsor: Centre Hospitalier Régional Metz-Thionville
Sponsor class: OTHER
Collaborators: name: University of Lorraine
name: Central Hospital, Nancy, France
First posted: 2019-04-02
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.
Primary purpose: SUPPORTIVE_CARE

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)

Eligibility criteria: 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

Primary outcomes:
measure: State Anxiety
timeFrame: Month 9
Secondary outcomes:
measure: quality of life of cancer patients
timeFrame: Month 9
measure: depression
timeFrame: Month 9
measure: posttraumatic symptoms
timeFrame: Month 9
Other outcomes:
Locations:
city: Metz
country: France
facility: CHR Metz-Thionville
Study officials:
affiliation: CHR Metz-Thionville
name: Raffaele LONGO, Dr
role: PRINCIPAL_INVESTIGATOR
References: