The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients

Sponsor
Herlev Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT01284751
Collaborator
(none)
21
1
1.9
10.8

Study Details

Study Description

Brief Summary

The purpose of this study is to measure depressive symptoms in breast cancer patients before surgery with Major Depression Inventory (MDI). The investigators hypothesize that this patient group will not produce scores correlating to having a mild, moderate or severe depression even though they have just recently experienced a major life crisis by receiving a malignant diagnosis.

Condition or Disease Intervention/Treatment Phase
  • Other: MDI - self-rating inventory

Detailed Description

The Major Depression Inventory is a self-rating depression scale with 12 questions. The questionnaire has previously been investigated in a Danish population. The scale contains the 10 ICD-10 (International Classification of Diseases)symptoms of depression and these symptoms are identical with the DSM-IV major depression symptoms with the exception of one symptom, low self-esteem, which in DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) is incorporated in the symptom of guilt. On a six-point Likert scale, the individual items measure how much of the time the symptoms have been present during the last 14 days. The MDI is then scored according to specific guidelines and can be used as both a rating scale and a diagnostic instrument.

Patients will approximately one week after the diagnosis of breast cancer has been made, corresponding to approximately one week before surgery, be asked to complete the MDI. Patients therefore only complete the MDI once in the whole study. At the same time a Mini Mental State Examination (MMSE) and questions regarding previous illnesses and medication will be asked. Patients will not be followed up in any way.

Study Design

Study Type:
Observational
Actual Enrollment :
21 participants
Observational Model:
Cohort
Time Perspective:
Cross-Sectional
Official Title:
The Use of Major Depression Inventory (MDI) in Measuring Preoperative Depressive Symptoms in Breast Cancer Patients
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
Mar 1, 2011
Actual Study Completion Date :
Mar 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Breast cancer patients

Patients aged 30-70 years having a lumpectomy or mastectomy at the Department of Breast Surgery at Herlev Hospital, Copenhagen, Denmark.

Other: MDI - self-rating inventory
MDI with 12 questions to be completed approximately 1 week before surgery

Outcome Measures

Primary Outcome Measures

  1. Depressive symptoms [Approximately one week before surgery]

    Total score on the Major Depression Inventory. When used as a diagnostic instruemtn patients witll according to the ICD-10 algorhythym be classified as mild, moderate or severe depression or no depression.

Eligibility Criteria

Criteria

Ages Eligible for Study:
30 Years to 70 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Women aged 30-70 years old, who are undergoing a lumpectomy or mastectomy

  • ASA I-III

Exclusion Criteria:
  • Planned or ongoing preoperative chemotherapy

  • Known and treated sleep apnea syndrome

  • Insulin treated diabetes mellitus

  • Known or previous treated depressive illness or bipolar disorder

  • Known autoimmune disease

  • Incompensated cirrhosis

  • Other previous or ongoing cancer

  • Known medically treated sleep disorder (insomnia, restless legs etc)

  • Shift-work or night-work

  • Daily alcohol intake of more than 5 units

  • Preoperative treatment with psychopharmacological drugs, opioids or anxiolytics

  • Predicted bad compliance

  • Pregnant or breast feeding

  • Preoperative MMSE score less than 24

Contacts and Locations

Locations

Site City State Country Postal Code
1 Herlev Hospital Herlev Denmark 2730

Sponsors and Collaborators

  • Herlev Hospital

Investigators

  • Principal Investigator: Melissa V Hansen, MD, Herlev Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01284751
Other Study ID Numbers:
  • MVH-04
  • H-1-2010-FSP
First Posted:
Jan 27, 2011
Last Update Posted:
May 12, 2011
Last Verified:
May 1, 2011
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 12, 2011