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A study of the effectiveness of transdiagnostic unified protocol on the treatment of posttraumatic stress disorder and comorbid symptoms in survivors of earthquake

Protocol summary

Study aim
Evaluation of the effectiveness of integrated ultrasound treatment on treatment Post-traumatic stress disorder and comorbid symptoms in earthquake survivors Sarpole Zahab in 1396
Design
This study controlled clinical trial Includes repeated measurements with an integrated ultrasound intervention recipient group and a routine treatment recipient group. The sample size is 33 individuals and all individuals attending the choice of therapist (those who attend the couple's day in the experimental group and those who receive the individual's day). They are included in the control group) randomly included in the experimental and control groups.
Settings and conduct
People referred to Farabi Clinic and Kermanshah Psychiatric Clinics and diagnosed by a psychiatrist are referred to a therapist and re-interviewed by a psychologist. Individuals receive sickness. The duration of each session is 90 minutes. Two months after the intervention, the subjects will be reassessed to assess follow-up. Treatment sessions include emotional awareness, attention awareness, recording and recognizing emotions, and so on.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Minimum 18 years old and 40 years old, minimum third grade education, participation in treatment, no symptoms of decompensation. Exclusion criteria: psychosis and bipolar disorder, uncontrollable flashback
Intervention groups
In this study, the experimental group (n = 11) received integrated ultrasound treatment, together with a guidebook for this treatment, and for the control group (n = 22), the Ministry of Health protocol treatment. The aim of the study was to evaluate the effectiveness of the integrated ultrasound treatment.
Main outcome variables
Depression, Anxiety, Sleep quality, Quality of life, Social adjustment, posttraumatic stress disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180421039369N4
Registration date: 2019-12-13, 1398/09/22
Registration timing: retrospective

Last update: 2019-12-13, 1398/09/22
Update count: 0
Registration date
2019-12-13, 1398/09/22
Registrant information
Name
Nasrin Jaberghaderi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 4622
Email address
nasrin.jaberghaderi@kums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-06-22, 1398/04/01
Expected recruitment end date
2019-07-23, 1398/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A study of the effectiveness of transdiagnostic unified protocol on the treatment of posttraumatic stress disorder and comorbid symptoms in survivors of earthquake
Public title
A study of the effectiveness of transdiagnostic unified protocol on the treatment of posttraumatic stress disorder
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Minimum age 18 and maximum 40 yesrs Minimum tertiary guidance education a person with post-traumatic stress disorder trauma after experiencing sarpole zahab earthquake as a diagnosis based on a psychologist Motivation and lack of motivation to participate in treatment No symptoms of disassociation.
Exclusion criteria:
Criteria exit :Psychotic and bipolar disorder, uncontrollable flashback
Age
From 18 years old to 40 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 33
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Kermanshah University of Medical Sciences
Street address
Central Building of Kermanshah University of Medical Sciences,Shahid Beheshti Blvd,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Approval date
2019-10-14, 1398/07/22
Ethics committee reference number
IR.KUMS.REC.1398.698

Health conditions studied

1

Description of health condition studied
Post Traumatic Stress Disorder
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
posttraumatic stress disorder
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
Mississippi Scale

Secondary outcomes

1

Description
Depression
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
Beck Depression Inventory(BDI-II)

2

Description
Anxiety
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
,Hamiton Rating Scale for Anxiety(HRSA)

3

Description
Quality of Life
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
Ware & Sherbourne Inventory,

4

Description
Sleep Quality
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
,Pittsburgh Sleep Quality Index

5

Description
posttraumatic stress disorder
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
Mississippi Scale

6

Description
Social Adjustment
Timepoint
A week befor the intervention,one week after the intervention,Two months after the intervention
Method of measurement
Bell Adjustment Questionnaire

Intervention groups

1

Description
Intervention group: In this study, Barlow's integrated, meta-diagnostic ultrasound treatment will be used. The sample included 33 individuals, divided randomly into two groups of experimental and control, with 11 subjects in the experimental group and 22 in the control group. A group will be provided individually for 12 sessions. The sessions consist of eight sections: Section 1) Increasing motivation to participate in therapy, Section 2) Psychological training and tracking of emotional experiences, Section 3) Emotional awareness training 4) Evaluating and modifying cognitive assessment, Section 5) Emotional avoidance Emotional behaviors, Section 6) Understanding Physical Emotions and Their Tolerance, Section 7) Exposure to External and Internal Emotions, Section 8) Preventing Recurrence
Category
Behavior

2

Description
Control group: Control group: control group consist of 22 people who are waiting in the waiting list and and do not receive treatment during the time of intervention.but after treatment ,they will receive ministry of health conventional treatment for maintaining the ethics of the control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Farabi Hospital
Full name of responsible person
Nahid Piri
Street address
Farabi Hospital, at the beginning of Dolatabad Boulevar , Isar Square, Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3827 1447
Email
nahidpiri1989@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Farid Najafi
Street address
Centeral Building of kermanshah University of Medical Sciences,Shahid Beheshti Blvd,Kermanshah
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 83 3442 8439
Email
farid-n32@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah 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
Kermanshah University of Medical Sciences
Full name of responsible person
Nahid piri
Position
ُStudent
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Isar Square at the begining of Dolat abad Hospital Farabi,Kermanshah
City
kermanshah
Province
Kermanshah
Postal code
6711594714
Phone
+98 83 3827 2949
Email
nahidpiri1989@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nahid Piri
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Isar Square at the begining of Dolat abad Hospital Farabi,Kermanshah.
City
Kermanshah
Province
Kermanshah
Postal code
6711591447
Phone
+98 83 3827 2949
Email
nahidpiri1989@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Nasrin Jaberghaderi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Facualty of Medicine,Imam Reza Hospital,Shahid Shiroudi Blvd
City
Kermanshah
Province
Kermanshah
Postal code
6715847141
Phone
+98 44 28468
Email
n-jaberghaderi@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Ther is no more information
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
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