Protocol summary

Summary
The aim of current Study of the effectiveness of group positive psychotherapy in reduce depression and enhancing of happiness and quality of life in patients with breast cancer. This study is a pretest- post test study with control group. The research community is of emam reza hospital and the required sample is 42 women. Inclusion criteria: Not receiving other concurrent psychiatric treatment or psychotherapy. Exclusion criteria: 29 to 63 score in beck depression inventory II. After sampling the subjects are randomly divided into two groups: positive psychotherapy and control groups. Data are collected at baseline and after interventions. Intervention group receive positive psychotherapy in 6 sessions in Kermanshah University of Medical Sciences

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101410063N4
Registration date: 2013-11-16, 1392/08/25
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2013-11-16, 1392/08/25
Registrant information
Name
Kheirollah Sadeghi
Name of organization / entity
Kermanshah University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 1826 0700
Email address
khsadeghi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
"Kermanshah University of Medical Science"
Expected recruitment start date
2013-04-04, 1392/01/15
Expected recruitment end date
2013-06-20, 1392/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effectiveness of group positive psychotherapy in reduce depression and enhancing of happiness and quality of life in patients with breast cancer.
Public title
Study of the effectiveness of group positive psychotherapy in reduce depression and enhancing of happiness and quality of life in patients with breast cancer.
Purpose
Treatment
Inclusion/Exclusion criteria
Individuals for entry into this study should have some criteria which are: 1. Not receiving other concurrent psychiatric treatment or psychotherapy. 2. the absence of other disorder in Axis 1. 3. The absence of oher disorder in Axis 2. 4. Consent to participate in the study and signed a consent form. 5. Not interfere in the process of breast cancer treatment. Exclusion criteria in this study include: 1. Sever Depression score on the Beck Depression Inventory. 2. Existence of Axis I disorder or any other obvious personality disorder on Axis II. 3. Health problems that would interfere with ongoing psychotherapy. 4. Symptoms of drug dependence in the past or present or have suicidal thoughts. 5. Out of people who may be affected by their breast cancer treatment process 6. Worsening of depression during treatment.
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 42
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
"Kermanshah University of Medical Science"
Street address
Vice – Chancellery of Research & Technology Affairs, building No.2,Shahid Beheshti Blvd, Kermanshah
City
Kermanshah
Postal code
Approval date
2013-05-06, 1392/02/16
Ethics committee reference number
5392

Health conditions studied

1

Description of health condition studied
breast cancer
ICD-10 code
C50
ICD-10 code description
Malignant neoplasm of breast

Primary outcomes

1

Description
Depression
Timepoint
before intervention and after intervention
Method of measurement
beck depression inventory II

Secondary outcomes

1

Description
Quality of life
Timepoint
befor and after intervention
Method of measurement
Quality of life breast cancer inventory

Intervention groups

1

Description
control group: receive no kind of treatments
Category
Behavior

2

Description
intervention group: group positive psychotherapy, duration: 6 session. any session 1.5 hour
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
emam reza Hospital in Kermanshah
Full name of responsible person
nasrin amirifar
Street address
Department of radiation and Oncology,emam reza Hospital. Parastar St., Daneshghah Bld., kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
Full name of responsible person
Mrs. Entezari
Street address
Chancellery of Research & Technology Affairs, building No.2,shahid beheshti blvd, Kermanshah
City
Kermanshah
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Chancellery of Research & Technology Affairs of Kermanshah University of Medical Science
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kermanshah University of Medical
Full name of responsible person
mohammad mehdi dowlatabadi
Position
Postgraduate student of clinical psychology
Other areas of specialty/work
Street address
Room 148, Boston Enghelab Dormitory, In front of Imam Reza Hospital, Kermanshah
City
kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
mm.dowlatabadi@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Science
Full name of responsible person
Nosratollah Montazeri
Position
Assistant professor of psychology/ph.d
Other areas of specialty/work
Street address
School of Medicine, Community Department, Kermanshah University of Medical Sciences, Parastar St., Daneshghah Bld., Kermanshah
City
Kermanshah
Postal code
Phone
+98 83 1826 0700
Fax
Email
n.montazzeri@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical
Full name of responsible person
mohammad mehdi dowlatabadi
Position
Postgraduate student of clinical psychology
Other areas of specialty/work
Street address
Room 148, Boston Enghelab Dormitory, In front of Imam Reza Hospital, Kermanshah
City
kermanshah
Postal code
Phone
00
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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