Protocol summary

Summary
This study examained the effect of cognitive behavioral hypnotherapy on body dysmorphic disorder and depression and disabality of these patiants. This study utilized a single subject design wich include three baseline phase, treatment phase lasting fifteen session and follow up phase. The study society was the city of Sanandaj in spring 2015. Three patients with body dysmorphic disorder participated in this study by purposive available sampling. The Yale-Brown Obsessive Compulsive Scale modified for Body Dysmorphic Disorder (BDD-YBOCS), Millon Clinical Multiaxial Inventory-III (MCMI-III) and clinical interview were used as diagnostic tools. The BDD-YBOCS, beck depression inventory (DBI-II) and Sheehan Disability Scale (SDS), were used every week in baseline phase and twice a week in treetment condition at beginning of each session.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016050425838N2
Registration date: 2016-09-04, 1395/06/14
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2016-09-04, 1395/06/14
Registrant information
Name
Morteza Abarin
Name of organization / entity
University of Kurdestan
Country
Iran (Islamic Republic of)
Phone
+98 17 3223 0046
Email address
m.abbarin@hum.uok.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research University of Kurdestan
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-06-05, 1394/03/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Efficacy of Cognitive Behavior Hypnotherapy for Body Dysmorphic Disorder
Public title
The Efficacy of Cognitive Behavior Hypnotherapy for Body Dysmorphic Disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: The age range between 18 and 48 years; BDD duration of at least 6 months; Read and write ability; Get score 21 or higher on BDD-YBOCS; Having a diagnosis of body dysmorphic disorder in the Diagnostic Interview Exclusion criteria: Having serious thoughts about suicide based on scores of suicide item of Beck Depression Inventory ;Having simultaneous psychotherapy; Having simultaneous pharmacotherapy for psychological disorders; Having cosmetic surgery during treatment
Age
From 18 years old to 45 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 3
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
the study was single subject design

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of University of Kurdistan
Street address
Sanandaj, Pasdaran street
City
Sanandaj
Postal code
Approval date
2015-03-07, 1393/12/16
Ethics committee reference number
1179836

Health conditions studied

1

Description of health condition studied
boby dysmorphic disorder
ICD-10 code
F45.2
ICD-10 code description
The essential feature is a persistent preoccupation with the possibility of having one or more serious and progressive physical disorders. Patients manifest persistent somatic complaints or a persistent preoccupation with their physical appearance. Normal

Primary outcomes

1

Description
body dysmorphic disorder severity
Timepoint
three baseline spaced one week- every session during treatment- four month follow up
Method of measurement
Yale-Brown Obsessive Compulsive Scale modified for Body Dysmorphic Disorder

Secondary outcomes

1

Description
depression severity
Timepoint
three baseline spaced one week- every session during treatment (twice a week)- four month follow up
Method of measurement
beck depression inventory (DBI-II)

2

Description
disability severity
Timepoint
three baseline spaced one week- every session during treatment (twice a week)- four month follow up
Method of measurement
Sheehan Disability Scale

Intervention groups

1

Description
cognitive behavior hypnotherapy 15 ninety-minute sessions
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
through announcements in Sanandaj
Full name of responsible person
morteza abbarin
Street address
gorgan- hesam street- hesam building- second floor
City
gorgan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice chancellor for research university of kurdestan
Full name of responsible person
madi zamestani
Street address
Pasdaran street, University of Kurdistan
City
Sanandaj
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 university of kurdestan
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
University of Kurdistan
Full name of responsible person
mahdi zemestani
Position
Faculty of Psychology, University of Kurdistan
Other areas of specialty/work
Street address
Pasdaran street, University of Kurdistan
City
Sanandaj
Postal code
Phone
+98 87 3366 4600
Fax
Email
m.zemestan@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
university of kurdestan
Full name of responsible person
mahdi zemestani
Position
Assist. Prof
Other areas of specialty/work
Street address
Pasdaran street, University of Kurdistan
City
Sanandaj
Postal code
Phone
+98 87 3366 4600
Fax
Email
m.zemestan@gmail.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Full name of responsible person
morteza abarin
Position
MA in Clinical Psychology- Principal investigator
Other areas of specialty/work
Street address
gargan- hesam street- ninth hesam alley- Samen residential complex- second floor
City
gorgan
Postal code
4916666667
Phone
+98 17 3223 0046
Fax
Email
morteza.abbarin@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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