Protocol summary

Summary
The goal of this study is to determine the effectiveness of therapy on meta-cognitive model on the depression, cognitive emotion regulation and meta-cognitive beliefs for depressed women, with breast cancer, referred to medical centers in Shiraz in 1395. In this experimental study, the two groups, pre -test and post-test are performed, forty eight patients with breast cancer, according to Beck Depression questionnaire, are affected by mild to moderate depression, randomly, into two groups and control allocated. The samples are excluded in case of unwillingness to continue the treatment or failure to participate in more than two sessions . While patients in the control group are underwent routine management measures, 8 weekly sessions will be formed for the experimental group, based on meta-cognitive therapy. Before and after the sessions, patients in both groups are evaluated with Beck Depression questionnaire, cognitive emotional regulation and metacognitive beliefs. Re-evaluations will be repeated these tests a month later to assess the effect of treatment.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201606288473N5
Registration date: 2016-09-05, 1395/06/15
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-09-05, 1395/06/15
Registrant information
Name
Masoud Bahreini
Name of organization / entity
Bushehr University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 77 3345 3836
Email address
m.bahreini@bpums.ac.ir
Recruitment status
Recruitment complete
Funding source
Bushehr University of Medical Sciences
Expected recruitment start date
2016-09-10, 1395/06/20
Expected recruitment end date
2016-10-06, 1395/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of Meta-cognitive therapy model on depression, cognitive emotion regulation and meta-cognitive beliefs in depressed patients with breast cancer
Public title
The effect of Metacognitive therapy on depression in women with breast cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Age 20-55 years; with Breast Cancer; ranging from mild to moderate depression score; the desire to participate in the study; lack of clear psychotic mental disorder; Exclusion criteria: lack of desire to continue to participate in the study; Failure to participate in more than two sessions
Age
From 20 years old to 55 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Does not have

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Bushehr University of Medical Sciences
Street address
Salman Farsi street, Sabz Abad, Bushehr
City
Bushehr
Postal code
7518759577
Approval date
2016-06-20, 1395/03/31
Ethics committee reference number
IR.BPUMS.REC.1395.52

Health conditions studied

1

Description of health condition studied
Depression
ICD-10 code
F32
ICD-10 code description
Depressive episode

Primary outcomes

1

Description
Depression
Timepoint
Before the intervention; after the intervention; one months after the intervention
Method of measurement
Beck Depression Inventory

Secondary outcomes

1

Description
Cognitive Emotion Regulation; Metacognitive Beliefs
Timepoint
Before the intervention; After the intervention; A month after intervention
Method of measurement
Cognitive Emotional Regulation Questioner; Meta Cognitive Questioner-30

Intervention groups

1

Description
In the case group, meta-cognitive group therapy method will be held for 8 sessions per week. Metacognitions placed in cognitive-behavioral third wave of the treatment field that instead of amending the content of cognition, the cognitive processing and correction mechanisms involved. In this approach, it is believed that in mental disorders, cognitive Self-Regulatory Executive Function (S-REF) is placed in a defective processing cycle, which is known as the cognitive attentional syndrome (CAS). This syndrome which is the result of positive and negative metacognitive beliefs, causes a diversion in attention, cognitive processing techniques, cognitive-emotional orientation, and thus, is the continuation of the disorder. The goal of the treatment is modification and decreasing cognitive attentional syndrome, with the help of the techniques of mindfulness, distraction, correction of negative and positive beliefs and pain and emotional suffering population.
Category
Treatment - Other

2

Description
There won't be any interfering for the control group and they will be treated routinely.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Breast Research Center
Full name of responsible person
Fatemeh Hoseini
Street address
Fifth floor Motahhari clinic, Namazi Square
City
Shiraz

2

Recruitment center
Name of recruitment center
Faghihi Hospital
Full name of responsible person
Street address
Faghihi Hospital, Zand Street, Shiraz, Iran
City
Shiraz

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice-chancellor for Research, Bushehr University of Medical Sciences
Full name of responsible person
Dr Afshin Ostovar
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Sabz Abad, Bushehr
City
Bushehr
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-chancellor for Research, Bushehr University of Medical Sciences
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
Bushehr University of Medical Sciences
Full name of responsible person
Eelham Zahedian
Position
Masters Student of Nursing
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Bushehr, Iran
City
Bushehr
Postal code
Phone
+98 77 3345 0187
Fax
Email
elhamzahed8766@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Masoud Bahreini
Position
PhD in nursing
Other areas of specialty/work
Street address
Bushehr University of Medical Sciences, Salman Farsi Street, Sabz Abad, Bushehr, Iran
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
Email
msdbahreini@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Bushehr University of Medical Sciences
Full name of responsible person
Masoud Bhareini
Position
PhD of Nursing
Other areas of specialty/work
Street address
Bushehr Univeristy of Medical Sciences, Salman Farsi Street, Sabz Abad ,Bushehr,Iran
City
Bushehr
Postal code
7518759577
Phone
+98 77 3345 0187
Fax
Email
msdbahreini@yahoo.com
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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