Protocol summary

Study aim
Determining the effectiveness of teaching dialectical behavior therapy skills on the resilience of transgender people. Determining the effectiveness of dialectic behavior therapy skills training on reducing internalized transphobia in transgender people.
Design
Semi-experimental before-after type with single groups, convenience sampling, on 18 transgender individuals.
Settings and conduct
Due to the cooperation of this plan with the forensic medicine, the place of the treatment sessions will be in one of the government hospitals approved by the forensic medicine.Referrals will be given explanations about the plan and purpose of its implementation, the optionality of participating in the study and the absence of additional fees. The sample members are selected from among the people who are eligible in terms of Inclusion and exclusion criteria. Dialectical behavioral therapy skills training program will be implemented in 10 sessions and two sessions per week.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 1- Verification of transgender identity by the Forensic Medicine Commission 2- Ability to understand therapeutic content 3- Minimum Middle school education 4- Age 18 to 50 years 5- Completing the informed consent form 6- Life in Iran exclusion criteria: 1- acute medical, psychiatric or surgical diseases.
Intervention groups
In this method, each person will be his own control and there is no separate control group. The intervention group is among transgender people. Dialectical behavior therapy skills training program is presented in 10 sessions, these skills are divided into 4 general categories of mindfulness skills, distress tolerance, emotional regulation and effective communication, and each of them is divided into two basic and advanced levels.
Main outcome variables
Resilience; internalized transphobia

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230801058999N1
Registration date: 2023-10-18, 1402/07/26
Registration timing: prospective

Last update: 2023-10-18, 1402/07/26
Update count: 0
Registration date
2023-10-18, 1402/07/26
Registrant information
Name
mohaddese sadeghi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3765 6650
Email address
sadeghimd991@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-10-23, 1402/08/01
Expected recruitment end date
2024-02-20, 1402/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of Teaching Dialectical Behavior Therapy Skills on resilience and reducing internalized transphobia of transgender people
Public title
The effect of teaching dialectical behavior therapy skills in transgender people
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of gender dysphoria based on DSM5 in the medical record, this term is considered equivalent to transgender identity in this study. Ability to understand therapeutic content Minimum Middle school education Age 18 to 50 years Complete the informed consent form life in Iran
Exclusion criteria:
History of active phase of acute medical or psychiatric diseases in the last 6 months
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 18
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
Ethics committee of Mashhad Univesity of Medical Sciences
Street address
Central Organization of Qurashi Building, University Street
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Approval date
2023-06-21, 1402/03/31
Ethics committee reference number
IR.MUMS.REC.1402.081

Health conditions studied

1

Description of health condition studied
Transgender people
ICD-10 code
F64.0
ICD-10 code description
Gender identity disorders Transsexualism: A desire to live and be accepted as a member of the opposite sex, usually accompanied by a sense of discomfort with, or inapprop

Primary outcomes

1

Description
Resilience
Timepoint
before the start of the study, the day of the end of the training and 1 month after the completion of the training
Method of measurement
Connor and Davidson Resilience Questionnaire

2

Description
Internalized Transphobia
Timepoint
before the start of the study, the day of the end of the training and 1 month after the completion of the training
Method of measurement
The 8-item subscale of internalized transphobia from the Minority Stress and Resilience Questionnaire of Testa et al.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Intervention group: Transgender people referring to the Transgender Center of Ibn Sina Mashhad Hospital and Mashhad Forensic Medicine in 1402-1403. This research will be done as a semi-experimental before-and-after type. And each person will be his own control. The sample members are selected by a simple random method. After selecting the participants, the training program of dialectical behavior therapy skills will be implemented on the experimental group in 10 sessions of 90 minutes, twice a week, under the supervision of the relevant professor, and in each session 20 People will participate and the patients will be asked to complete the tasks that are needed to consolidate the training and better effectiveness of the treatment. Connor and Davidson Resilience Questionnaire (CD-RISC) and internalized transphobia (IT) will be administered before the intervention (day zero) and at the end of the training as a post-test to ensure the stability of the results over time one month later. The results of the treatment are followed up after the sessions. The content of the dialectical behavior therapy training sessions: first session: stating the rules of group therapy sessions; including the purpose of holding the meetings, the duration and number of meetings, the conditions for exiting the meetings and answering the questions of the participants in this field. The definition of the term dialectic and the principles and methods underlying thinking and behavior in the dialectical behavior therapy approach, familiarization and explanation of pervasive awareness and emotional, rational and logical states of mind. The second session: the centrality of teaching the basic skills of distress tolerance; including relaxation and self-soothing, turning attention from self-harming behaviors to pleasurable activities, leaving the situation and diverting attention to another issue The third session: the centrality of teaching advanced distress tolerance skills; Among them, visualizing a safe place, living in the present moment, discovering individual values, accepting fundamentals, formulating new coping strategies and coping plans in stressful situations. The fourth session: the centrality of teaching the fundamental skills of mindfulness; Among them, neglecting and mindfulness and practicing it. The fifth session: the centrality of teaching advanced skills of mindfulness; Among them, the wise mind, fundamental acceptance and initiatory mind, judgments and labels, non-judgment and everyday experience, the application of mindfulness in relationships and daily life, and recognizing and examining the obstacles ahead in performing mindfulness exercises. The sixth session: focusing on the fundamental skills of emotional regulation; Among them, the recognition of emotions and the process of emotion regulation, overcoming the obstacles to experiencing healthy emotions, reducing physical vulnerability to disturbing emotions and increasing the experience of positive emotions. The seventh session: focusing on teaching advanced emotional regulation skills; including, paying mindfulness to emotions without judging them, how to face positive and negative emotions, acting against strong emotional desires and problem solving The eighth session: focusing on the fundamental skills of effective communication; Among them, recognizing passive-aggressive behavior, compatibility between my desires and the desires of others, proportionality of individual desires and needs, learning key interpersonal skills and knowing the obstacles to their use. Session 9: Focusing on education Advanced effective communication skills; including identifying demands, adjusting the intensity of demands, bold draft, bold listening, saying no, and how to negotiate and analyze interpersonal problems. The 10th session: summarizing and reviewing what was presented in the entire sessions, evaluating the amount of results obtained from the sessions and the therapeutic goals of the content of the sessions based on McKay, Wood and Brantley behavioral therapy techniques.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Khorasan Razavi Forensic Medicine
Full name of responsible person
Farshad Sheibani
Street address
next to Astan Quds Razavi, Harameli St.
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3712 7017
Email
sheibanifr@mums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farshad Sheibani
Street address
Central Organization of Qurashi Building, University Street,
City
Mashhad
Province
Razavi Khorasan
Postal code
١٣٩۴۴ ٩١٣٨٨
Phone
+98 51 3841 2081
Email
sheibanifr@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Farshad Sheibani
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Ibn Sina Psychiatric Hospital, next to Astan Quds Razavi, Haramali St.
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
00983712701-7
Email
sheibanifr@mums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohaddese Sadeghi
Position
Master's student in clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Ibn Sina Psychiatric Hospital, next to Astan Quds Razavi, Haramali St.
City
Mashahad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3712 7017
Email
sadeghimd991@mums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Mohaddese Sadeghi
Position
Master's degree fromd mashhad university of medical sciences
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Unit 4, No. 26, Resalat 31, Faramarz Abbasi 17
City
Mashhad
Province
Razavi Khorasan
Postal code
919583134
Phone
+98 51 3765 6650
Fax
Email
sadeghimd991@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data can be shared after de-identifying people.
When the data will become available and for how long
Access starts 6 months after results are published
To whom data/document is available
The data will be accessible to the editor-in-chief of the journal in which the article was published and to the researchers working in academic and scientific institutions if they provide valid reasons.
Under which criteria data/document could be used
It can be used if valid reasons are presented to the responsible author.
From where data/document is obtainable
Dr. Farshad Sheibani: sheibanifr@mums.ac.ir Mohaddese Sadeghi: sadeghimd991@mums.ac.ir
What processes are involved for a request to access data/document
After sending the request by mentioning the reasons to the entered emails, the authors will send the data file or the data access code which is registered in valid databases to the applicant after checking and if they agree with this request.
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