EMDR Psychotherapy for Anxious-depressive Symptoms in Breast Cancer Patient

NCT03898453 | Completed DMC

• 1 other identifier: 2018-A01128-47
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female

Keywords

Breast Cancer; support psychotherapy; EMDR therapy; anxiety disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• quality of life of cancer patients

  Month 9

• depression

  Month 9

• posttraumatic symptoms

  Month 9

Study Arms (2)

Group EMDR psychotherapy

EXPERIMENTAL

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)

Behavioral: EMDR psychotherapy

Group Control : support psychotherapy

OTHER

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)

Behavioral: support psychotherapy

Interventions

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)

Group EMDR psychotherapy

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)

Group Control : support psychotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University of Lorraine: collaborator
• Central Hospital, Nancy, France: collaborator

Study Sites (1)

CHR Metz-Thionville

Metz, 57085, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Anxiety Disorders

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Mental Disorders

Study Officials

• Raffaele LONGO, Dr

  CHR Metz-Thionville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two groups assignment - One group will receive EMDR psychotherapy the other one support psychotherapy.

Study Record Dates

• First Submitted: January 30, 2019
• First Posted: April 2, 2019
• Study Start: March 11, 2019
• Primary Completion: September 24, 2023
• Study Completion: September 24, 2023
• Last Updated: October 23, 2023

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)