EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

Breast Cancer Female Clinical Trial

— PSYCANCER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03898453
• Other study ID #: 2018-A01128-47
• Status: Completed
• Phase: N/A
• Start date: March 11, 2019
• Est. completion date: September 24, 2023

Study information

• Verified date: September 2022
• Source: Centre Hospitalier Régional Metz-Thionville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: September 24, 2023
• Est. primary completion date: September 24, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Neoplasms
• Depression

Intervention

Behavioral:
• 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)
• 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)

Locations

Country	Name	City	State
France	CHR Metz-Thionville	Metz

Sponsors (3)

Lead Sponsor	Collaborator
Centre Hospitalier Régional Metz-Thionville	Central Hospital, Nancy, France, University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	State Anxiety	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.	Month 9
Secondary	quality of life of cancer patients	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.	Month 9
Secondary	depression	CES-D (The Center for Epidemiologic Studies Depression) Questionnaire	Month 9
Secondary	posttraumatic symptoms	PTGI (The Posttraumatic Growth Inventory) Questionnaire	Month 9