Protocol summary

Summary
The main purpose of the current study is to determine effectiveness of hypnotherapy on improving negative body image, self-esteem, depression and anxiety in women referring to the health club. A single-case experimental trial of multiple-baseline type is carried out on six females. Before the treatment sessions starts, special tools such as negative body image, Coppersmiths' Self-steam, depression and anxiety questionnaires will be used. To determine the baseline in anxiety, depression and self-esteem, during a week, every day, participants evaluate by questionnaire, the mean scores for each person on the tests consider as a base rate line. The participants receive eight sessions of hypnosis therapy (once a week). First, it emphasizes, truthfully that while hypnosis is a very interesting experience; it is not really all that different from certain experiences that may be familiar from the ordinary course of everyday living. Furthermore, subjects are informed that while they may have some unusual experiences while they are hypnotized, they will always remain in contact with reality and in control with what is going on. Participants sign a statement of informed consent informing them of their freedom to withdraw at any time. Participants select through convenience sampling method. To prevent bias, screening and evaluation of participants during the course of treatment is done by a different person with relevant education. The inclusion criteria are required the negative body image, required the mild or moderate self-esteem, Having exercise at least six months prior to the study, the exclusion criteria are the depression episode is attributable to the physiological effect, receiving psychiatric treatment or psychotherapy (patients should not receive psychological treatment or medication at least six months before research).

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016062528633N1
Registration date: 2016-07-07, 1395/04/17
Registration timing: prospective

Last update:
Update count: 0
Registration date
2016-07-07, 1395/04/17
Registrant information
Name
Mahtab Sadeghi
Name of organization / entity
Kermanshah University Of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 83 3835 0177
Email address
kums2017@gmail.com
Recruitment status
Recruitment complete
Funding source
Research Council of Kermanshah University of Medical Sciences
Expected recruitment start date
2016-07-22, 1395/05/01
Expected recruitment end date
2016-09-22, 1395/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of hypnotherapy on improving self-esteem, negative body image, depression, and anxiety in women referring to the health club
Public title
Effect of hypnotherapy on improving self-esteem, negative body image, depression, and anxiety in women referring to the health club
Purpose
Prevention
Inclusion/Exclusion criteria
The inclusion criteria: required the negative body image score in the BSQ-34, required the mild or moderate self-esteem (less than 26) in the Coopersmith Self-steam Inventory, required the depression score in the BDI-II between 14 and 28 (mild and moderate depression), diagnosed depressive disorder based on the Diagnostic Interview (SCID-I), required the anxiety score in the BAI between 8 and 25 (mild and moderate anxiety) and diagnosed anxiety disorder based on the Diagnostic Interview (SCID-I), Having exercise at least six months prior to the study, Willingness to participate in study (by signing the informed consent). The exclusion criteria: Having other disorders in the axis I (other than depression and anxiety), the depression episode is attributable to the physiological effects, psychotic symptoms such as hallucinations and delusions, suicidal thought or severe depression, receiving psychiatric treatment or psychotherapy (patients should not receive psychological treatment or medication at least six months before research).
Age
From 18 years old to 50 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 6
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Kermanshah University Of Medical Science
Street address
School of Medicine, Department of clinical psychology, Shahid Shiroudi
City
kermanshah
Postal code
Approval date
2016-04-27, 1395/02/08
Ethics committee reference number
KUMS.REC.1395.50

Health conditions studied

1

Description of health condition studied
depression
ICD-10 code
F32.1
ICD-10 code description
Moderate depressive episode

2

Description of health condition studied
anxiety
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders

3

Description of health condition studied
low self-esteem
ICD-10 code
Z61.3
ICD-10 code description
Events resulting in loss of self-esteem in childhood

4

Description of health condition studied
negative body image
ICD-10 code
F45.2
ICD-10 code description
Hypochondriacal disorder

Primary outcomes

1

Description
negative body image
Timepoint
2,4,6,8 weeks after base rate
Method of measurement
BSQ-34

2

Description
Depression
Timepoint
2,4,6,8 weeks after base rate
Method of measurement
Beck Depression Inventory (BDI-II)

3

Description
anxiety
Timepoint
2,4,6,8 weeks after base rate
Method of measurement
Beck anxiety inventory

4

Description
Self-esteam
Timepoint
2,4,6,8 weeks after base rate
Method of measurement
Coopersmith Self-steam questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
eight sessions of hypnosis therapy (once a week)
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
Nobahar health club
Full name of responsible person
Ali MAzaheri
Street address
Nobahar Street, Shadi behshti "Blvd ", kermanshah
City
Kermanshah

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research Council of Kermanshah University of Medical Sciences
Full name of responsible person
Behrooz Hamzeh
Street address
Research and technology deputy, Building "No."2, Shahid Beheshti "Blvd."
City
Research and technology deputy, Building
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Council of Kermanshah 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
Kemanshah University of Medical Sciences
Full name of responsible person
Khierollah Sadeghi
Position
Assistant professor
Other areas of specialty/work
Street address
Department of clinical psychology, school of medicine, Shahid Shiroudi "Blvd."
City
Kermanshah
Postal code
Phone
00
Fax
Email
k.sadeghi@kums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Aliakbar Parvizifard
Position
Assistant professor
Other areas of specialty/work
Street address
Department of Clinical psychology, school of Medicine, Shahid Shiroudi "Blvd."
City
Kermanshah
Postal code
Phone
+98 83 3838 4185
Fax
Email
parvizia@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University Of Medical Science
Full name of responsible person
Mahtab Sadeghi
Position
M.sc. student
Other areas of specialty/work
Street address
Department of clinical psychology, school of medicine, Shahid Shiroudi "Blvd."
City
Kermanshah
Postal code
Phone
00
Fax
Email
mahtab1.sadeghi70@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
Loading...