Clinical Trials Directory

Trials / Completed

CompletedNCT03898453

EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

EMDR Psychotherapy of Anxious-depressive Symptoms for Women That Present an Invasive Breast Cancer : a Randomised Controlled Trial

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
64 (actual)
Sponsor
Centre Hospitalier Régional Metz-Thionville · Academic / Other
Sex
Female
Age
18 Years
Healthy volunteers
Not accepted

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)

Conditions

Interventions

TypeNameDescription
BEHAVIORALEMDR psychotherapyVisit 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)
BEHAVIORALsupport psychotherapyVisit 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)

Timeline

Start date
2019-03-11
Primary completion
2023-09-24
Completion
2023-09-24
First posted
2019-04-02
Last updated
2023-10-23

Locations

1 site across 1 country: France

Source: ClinicalTrials.gov record NCT03898453. Inclusion in this directory is not an endorsement.