Protocol summary

Summary
Gender identity is individual sense of being male or female and normally corresponded to the individual anatomy gender. Gender Identity Disorder (GID), a disorder characterized by the sustained strong preference for adopting the status and role of the opposite sex. In this study, based on the approach of spiritual psychotherapy, spiritual component of love of others, love of work, love of belonging, belief in God, belief in the unity and belief in transformation will be used in designing Spiritual Psychotherapy package for people with gender identity disorder (GID). In this study, the Spiritual Psychotherapy package is designed for people with GID, then face and content validity is also evaluated using focus group discussions with experts. Then this treatment package will perform for 5 people with GID in this preliminary study, and feasibility will be examined. Suffering GID will be evaluated Using the criteria of DSM-V (According to psychiatrist), and the spiritual health and quality of life of these patients were compared before and after the implementation of the package using the spiritual health and quality of life questionnaires.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201701149127N3
Registration date: 2017-02-15, 1395/11/27
Registration timing: prospective

Last update:
Update count: 0
Registration date
2017-02-15, 1395/11/27
Registrant information
Name
Maryam Salmanian
Name of organization / entity
Tehran University of medical sciences, psychiatry and psychology research center
Country
Iran (Islamic Republic of)
Phone
+98 21 5541 3540
Email address
marysal1981@gmail.com
Recruitment status
Recruitment complete
Funding source
Deputy of research, Tehran University of Medical Sciences
Expected recruitment start date
2018-01-21, 1396/11/01
Expected recruitment end date
2018-09-23, 1397/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and implementation of the package of spiritual psychotherapy to treat people with gender identity disorder (GID)
Public title
Effectiveness of spiritual psychotherapy in treatment of gender identity disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: 1. Patients with Gender Identity Disorder (GID) with psychiatrist diagnosis 2. subjects aged between 18 and 30 years Exclusion criteria: 1. Failure to receive a diagnosis of gender identity disorder by a psychiatrist 2. subjects aged less than 18 or more than 30 years
Age
From 18 years old to 30 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 5
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Tehran university of medical sciences
Street address
Deputy of research, Tehran university of medical sciences, At the corner of the Qods street, Bolvare Keshavarz, Tehran.
City
Tehran
Postal code
Approval date
2017-02-05, 1395/11/17
Ethics committee reference number
IR.TUMS.VCR.REC.1395.1652

Health conditions studied

1

Description of health condition studied
Gender Identity Disorder
ICD-10 code
F64.0
ICD-10 code description

Primary outcomes

1

Description
spiritual health
Timepoint
before and after intervention
Method of measurement
spiritual health aquestionnaire

2

Description
quality of life
Timepoint
before and after intervention
Method of measurement
quality of life questionnaire

Secondary outcomes

empty

Intervention groups

1

Description
In this study, firstly the Spiritual Psychotherapy package is designed for people with GID, then face and content validity is also evaluated using focus group discussions with experts. Then this treatment package will perform for 5 people with GID in this preliminary study, and feasibility will be examined.
Category
Behavior

Recruitment centers

1

Recruitment center
Name of recruitment center
psychiatry and psychology research center, Tehran university of medical sciences
Full name of responsible person
Dr. Maryam Salmanian
Street address
Roozbeh Hospital, South Kargar Avenue, Tehran, Iran.
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran university of medical sciences
Full name of responsible person
Mrs. Karimi
Street address
At the corner of Qods street, Bolvare Keshavarz, Tehran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran 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
Tehran university of medical sciences
Full name of responsible person
Dr. Maryam Salmanian
Position
PhD by Research/ K factor researcher
Other areas of specialty/work
Street address
Psychiatry and Psychology Research Center, Roozbeh Hospital, South Kargar Avenue, Tehran.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
m-salmanian@razi.tums.ac.ir
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
psychiatry and psychology research center, Tehran university of medical sciences
Full name of responsible person
Dr, Maryam Salmanian
Position
PhD by REsearch
Other areas of specialty/work
Street address
psychiatry and psychology research center, Roozbeh Hospital, South Kargar Avenue, Tehran.
City
Tehran
Postal code
Phone
+98 21 5541 3540
Fax
Email
m-salmanian@razi.tums.ac.ir
Web page address

Person responsible for updating data

Contact

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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