Protocol summary

Summary
The present study is a pretest-posttest clinical trial with a control group. The aim of this study is determination of the efficacy of combined cognitive and hypnosis therapy in depression and quality of life in patients with breast cancer at Imam Khomeini Hospital in Mazandaran, Iran. The statistical population consisted of all patients with breast cancer who were referred to Tooba Clinic and Imam Khomeini Hospital in Sari. 32 patients were randomly assigned into two groups of cognitive behavioral therapy with hypnosis and conventional therapy, and each group included 16 patients .Inclusion criteria include breast cancer diagnosis, writing literacy, physical ability, medical treatment, chemotherapy, hypnosis grade5, and more than 5 SPIEGELs and over 18 years of age, and exclusion criteria including history of attending other psychotherapy sessions, use Psychiatric drugs, acute mental disorder, illiterate, psychiatry (comorbidity).Hypnosis with cognitive-behavioral therapy will be performed in 8 one-hour weekly sessions for the experimental group, and the control group will be waiting and all patients will be complete the consent form. Demographic form, resilience, anxiety and depression questionnaire and quality of life questionnaire will be completed at the beginning of treatment, the end of treatment and 2months after treatment by patients.

General information

Acronym
Cognitive-Behavioral Therapy plus Hypnosis in cancer
IRCT registration information
IRCT registration number: IRCT201703161457N13
Registration date: 2017-11-20, 1396/08/29
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2017-11-20, 1396/08/29
Registrant information
Name
Mehran Zarghami
Name of organization / entity
Research Center for Psychiatry and Behavioral Sciences and Department of Psychiatry, Mazandaran Univ
Country
Iran (Islamic Republic of)
Phone
+98 15 1328 5659
Email address
mzarghami@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mazandaran University Of Medical sciences
Expected recruitment start date
2017-04-04, 1396/01/15
Expected recruitment end date
2018-01-31, 1396/11/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Efficacy of Cognitive-Behavioral Therapy plus Hypnosis (CBTH) intervention on anxiety, depression and quality of life in patients with breast Cancer: A randomized controlled trial
Public title
Efficacy of Cognitive-Behavioral Therapy plus Hypnosis (CBTH) intervention in patients with breast Cancer
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria include breast cancer diagnosis, writing literacy, physical ability, medical treatment, chemotherapy, hypnosis grade5, and more than 5 SPIEGELs and over 18 years of age, and exclusion criteria including history of attending other psychotherapy sessions, use Psychiatric drugs, acute mental disorder, illiterate, metastatic breast cancer patients, incomplete questionnaires, medical psychiatry (co-morbidity).
Age
No age limit
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Block randomized Trial

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran university of medical sciences
Street address
sari,juibar roud
City
Sari
Postal code
Approval date
2016-09-22, 1395/07/01
Ethics committee reference number
IR.MAZUMS.REC.95.2225

Health conditions studied

1

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

Primary outcomes

1

Description
Anxiety
Timepoint
2 months
Method of measurement
questionnair

2

Description
Depression
Timepoint
2 months
Method of measurement
questionnair

Secondary outcomes

1

Description
resilience
Timepoint
2 months
Method of measurement
Questionnaire

2

Description
Quality of life
Timepoint
2 months
Method of measurement
Questionnaire

Intervention groups

1

Description
combination of Hypnoses and cognitive behavioral therapy in 8 one-hour weekly sessions in group
Category
Behavior

2

Description
common treatment
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Fatemeh taghizadeh
Street address
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy of research and technology of Mazandaran university of medical sciences
Full name of responsible person
Dr Majid saeedi
Street address
Sari,moallem SQ
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy of research and technology of Mazandaran 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
Mazandaran University of medical sciences
Full name of responsible person
Fatemeh taghizadeh
Position
MSc
Other areas of specialty/work
Street address
Sari,Addiction institute
City
Sari
Postal code
Phone
+98 11 3311 3278
Fax
Email
fatemehtaghizadeh93@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Addiction institute
Full name of responsible person
Dr.mehran zarghami
Position
psychiatrist
Other areas of specialty/work
Street address
Sari,Addiction institute
City
Sari
Postal code
Phone
+98 11 3328 5659
Fax
Email
Mehran.zarghami@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
Fatemeh taghizadeh
Position
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
fatemehtaghizadeh93@gmail.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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