Protocol summary

Study aim
The effectiveness of trauma-focused cognitive-behavioral therapy on body image, trauma-related memory quality, self-harm, emotion regulation, and Dissociative experiences in adolescents with complex post-traumatic stress disorder.
Design
A clinical trial study with a control group of Parallel groups, one-blind, randomized groups was performed on 32 people, and random generator software was used for randomization.
Settings and conduct
The present study is applied in terms of purpose and available sampling method in the data collection method. This study is a single-blind clinical trial with a control and experimental group. First, the International Trauma Questionnaire for adolescents with trauma is standardized to obtain valid data, and then to conduct research, preferably a psychologist By referring to the forensic medicine center and psychology clinic of Taleghani hospital in Tehran, examines the patients' files. By determining the admission criteria and considering the International Trauma Questionnaire and clinical interview score, people diagnosed with post-traumatic stress disorder are complicated. , Are selected using the available sampling method in 1401 and are randomly divided into experimental and control groups.
Participants/Inclusion and exclusion criteria
Willingness to participate in research. Do not take psychiatric drugs. Do not have mental disorders. Do not have suicidal thoughts. Simultaneous participation in psychological intervention. 2 consecutive absences.
Intervention groups
The experimental group receives trauma-focused cognitive therapy according to a 12-session protocol.
Main outcome variables
Self-harm- emotion regulation-Body image-Trauma-related memory quality-Dissociative experiences.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20201009048974N4
Registration date: 2022-05-07, 1401/02/17
Registration timing: prospective

Last update: 2022-05-07, 1401/02/17
Update count: 0
Registration date
2022-05-07, 1401/02/17
Registrant information
Name
Maryam Bakhtiari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2303 1548
Email address
maryam_bakhtiyari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-10-23, 1401/08/01
Expected recruitment end date
2023-03-19, 1401/12/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of trauma-focused cognitive-behavioral therapy(TF-CBT) on adolescents' psychological and cognitive structures with complex post-traumatic stress disorder(CPTSD).
Public title
The effectiveness of trauma-focused cognitive-behavioral therapy in adolescents with complex post-traumatic stress disorder.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 12 and maximum 18 years. To obtain the desired score in the International Trauma Questionnaire (to diagnose CPTSD, in addition to getting the required score in PTSD clusters, the person must have a score equal to or higher than 10 in the DSO cluster for items AD5-AD1 or a score similar to AD6-AD9 or Above 10, score NSC equal to or higher than eight and score DR points equal to or higher than 6). Not having adolescents with mental disorders requiring immediate treatment such as substance abuse and psychotic disorders based on clinical interview. Lack of intense thinking about self-harm or suicide. Not participating in psychological interventions during the last year (not participating in at least five psychotherapy sessions). Willingness to participate in research. Do not use psychiatric drugs.
Exclusion criteria:
Two consecutive absences in the process of meetings. Thinking about suicide during the research Adolescents suffer from mental disorders requiring immediate treatment, such as substance and alcohol use disorders and psychotic disorders during the study Simultaneous participation in another psychotherapy program.
Age
From 12 years old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 32
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be a simple Randomization method. The random unit is individuals.32 Adolescents with complex post-traumatic stress disorder will be divided into intervention and control groups by the software Exel software using Rand. in this way, a table of random numbers is prepared, and the Randbetween function is created. The adolescents are divided into two groups of 16 people, respectively.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor in data collection after the intervention and the analysts will be unaware of the study's objectives.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Iran - Tehran - Shahid Chamran Highway Yemen Street - Shahid Arabi Street - next to Ayatollah Taleghani Hospital - Shahid Beheshti School of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1983963113
Approval date
2022-03-08, 1400/12/17
Ethics committee reference number
IR.SBMU.MSP.REC.1400.830

Health conditions studied

1

Description of health condition studied
Complex post-traumatic stress disorder
ICD-10 code
F43.1
ICD-10 code description
Post-traumatic stress disorder (PTSD)

Primary outcomes

1

Description
self-harm
Timepoint
Beginning of the study (before the intervention) -6 months after the intervention.
Method of measurement
Sanson et al. Self -harm Questionnaire (SHI).

2

Description
Difficulty regulating excitement
Timepoint
Beginning of the study (before the intervention) -6 months after the intervention.
Method of measurement
Gretz and Roemer Emotion Difficulty Questionnaire (DERS).

3

Description
Bode Image
Timepoint
Beginning of the study (before the intervention) -6 months after the intervention.
Method of measurement
Littleton.Body Image Fear Questionnaire (BICI)

4

Description
Trauma-related memory quality
Timepoint
Beginning of the study (before the intervention) -6 months after the intervention.
Method of measurement
Meiser-Stedman. Trauma Memory Quality Questionnaire (TMQQ).

5

Description
Dissociative experiences
Timepoint
Beginning of the study (before the intervention) -6 months after the intervention.
Method of measurement
Bernstein and Carlson. Dissociative Experiences Scale (DES-II)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: For the experimental group, trauma-focused cognitive therapy is conducted according to the protocol of Cohen et al. Their treatment routine is 12 sessions of 45 minutes, once a week as an individual, which will be performed by a psychologist who is a doctoral student in clinical psychology under the supervision of a tutor. This method has been developed as a step-by-step approach that includes the following components: 1- psychoeducation and parenting skills, 2- Relaxation skills, 3- Emotional adjustment and expression, 4- Cognitive processing and coping and trauma narration, 6- Trauma reminders in Body, 7- Joint parent-child therapy sessions, 8- Strengthening security and 9- Future growth.
Category
Treatment - Other

2

Description
Control group: Initially, the control group did not receive any intervention, and only the results of their assessments performed by the questionnaire will be compared with the intervention group. At the end of the study, the trauma-focused cognitive-behavioral intervention will be completed in 12 individual 45-minute sessions according to the Cohen protocol.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ayatollah Taleghani Hospital
Full name of responsible person
Homa Shahkaram
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 3032 1111
Email
taleghanihospital@Sbmu.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afsin Zarghi
Street address
Vice-Chancellor of Research Affairs,Shahid Beheshti University of Medical Sciences, Next to Taleghani hospital, Erabi Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2243 9770
Email
Intl-office@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Maryam Bakhtiari
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2303 1548
Email
dr.m.bakhtiari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Shahkaram
Position
PhD Student in Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 3203 1548
Email
Homa.shahkaram@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Homa Shahkaram
Position
PhD Student in Clinical Psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Psychology Group, Floor4, Taleghani hospital, Erabi Ave., Yaman Ave., Chamran highway
City
Tehran
Province
Tehran
Postal code
1983963113
Phone
+98 21 2303 1548
Email
Homa.shahkaram@sbmu.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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