This study is conducted to assess the efficacy of combined therapy (citalopram and group-psychotherapy) in breast cancer patients with depressive disorder. The main measures for patient enrollment are recently diagnosis of breast cancer besides psychiatrist´ s diagnosis on major depressive disorder. The patients with other major psychiatric disorders such as psychosis or substance abuse will be excluded. Other exclusive measures are neurologic diseases, mental retardation and endocrine disorders. Study population is female breast cancer patients who are referred to cancer- treatment centers affiliated to Babol University of Medical Sciences, in Northern Iran, near Caspian Sea. In this research, 40 patients in the two groups (case and control) will be examined. 20 patients in the control group will receive 20-40 milligram citalopram in a day; this dose will be adjusted based on the patient´s tolerance and treatment response. 20 patients in the case group will participate in group cognitive-behavioral psychotherapy classes besides citalopram prescription. An educated psychologist will take this psychotherapy program. The two groups will be matched in their age. Group-psychotherapy sessions will be held weekly, free and at least 45 minutes in duration. The patients will be followed in the 3rd, 6th and 12th weeks of treatment. In these follows, the patients will be visited by the psychiatrist, their symptoms will be assessed and related questionnaires will be filled out. Treatment response is defined as a 50% reduction in depression and anxiety scores in comparison with the baseline scores. The primary outcomes which should be evaluated are treatment response and the patients´ quality of life.
General information
Acronym
-
IRCT registration information
IRCT registration number:IRCT2015063022991N1
Registration date:2016-01-23, 1394/11/03
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-01-23, 1394/11/03
Registrant information
Name
Sussan Moudi
Name of organization / entity
Babol University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 11 3236 5683
Email address
sussan.mouodi@mubabol.ac.ir
Recruitment status
Recruitment complete
Funding source
Babol University of Medical Sciences
Expected recruitment start date
2015-06-22, 1394/04/01
Expected recruitment end date
2015-08-22, 1394/05/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the efficacy of group-psychotherapy on breast cancer patients with major depressive disorder who are receiving citalopram
Public title
Psychotherapy in Major Depressive Breast Cancer Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Breast cancer in the stage III or more; HADS score equals or more than 11 which can be due to symptomatic major depression; informed consent of the patient for participation in the study
Exclusion criteria: severe psychiatric disorders such as psychosis or substance abuse; severe neurologic diseases; mental retardation; endocrine disorders
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Babol University of Medical Sciences
Street address
Babol, Ganjafrooz ave.
City
Babol
Postal code
4136747176
Approval date
2014-06-09, 1393/03/19
Ethics committee reference number
4232
Health conditions studied
1
Description of health condition studied
Neoplasms
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast
Primary outcomes
1
Description
quality of life
Timepoint
3th, 6th and 12th weeks
Method of measurement
WHO Quality of Life Questionnaire (WHO-QOL BREF)
2
Description
severity of depression in the patient
Timepoint
3th, 6th and 12th weeks
Method of measurement
Hospital Anxiety and Depression Scale (HADS)
Secondary outcomes
1
Description
the number of suicidal attempts
Timepoint
3th, 6th and 12th weeks
Method of measurement
self-report questionnaire
Intervention groups
1
Description
Control group: citalopram tablets, 20- 40 milligram per day (adjusted based on the patient tolerance and treatment response), for 12 weeks
Category
Treatment - Drugs
2
Description
Intervention group: Besides citalopram tablets (20-40 milligram per day) will participate in group cognitive behavioral psychotherapy classes. These group- therapy sessions are held weekly, free in price and lasting at least 45 minutes in each session. An educated psychologist will take this classes.
Category
Behavior
Recruitment centers
1
Recruitment center
Name of recruitment center
hospitals affiliated to Babol University of Medical Sciences