Skip to main content
OpenTrials
Completed

NCT Number: NCT03898453

EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville

Metz, 57085, France

About this study

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)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

EMDR psychotherapy

Behavioral

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)

support psychotherapy

Behavioral

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 outcomes

  1. State Anxiety

    Time frame: 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 outcomes

  1. quality of life of cancer patients

    Time frame: 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.

  2. depression

    Time frame: Month 9

    CES-D (The Center for Epidemiologic Studies Depression) Questionnaire

  3. posttraumatic symptoms

    Time frame: Month 9

    PTGI (The Posttraumatic Growth Inventory) Questionnaire

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Collaborators

  • Central Hospital, Nancy, France
  • University of Lorraine

Registry information

Official study title

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

Acronym: PSYCANCER

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Apr 2, 2019
Registry last updated
Oct 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.