Evaluation of the effectiveness of Tension and Trauma Releasing Exercises (TRE) on psychological symptoms and mindfulness in individual with anxiety disorders
The purpose of this research is to use Tension and Trauma Releasing exercise (TRE) on people with anxiety disorders in order to improve the state of anxiety and mindfulness
Design
The current research is a clinical trial in the experimental method of a single subject design with a pre--test and post-test with 5 participants and as a single group with a one month follow up plan.
Settings and conduct
Place of study:Dr.Sohrabi and Dr.Samani's calm psychology Clinic is in Shiraz; Target population: There are five people who train twice a week for 4 to 6 weeks; How to blind: Blinding won't be done in this study
Participants/Inclusion and exclusion criteria
Inclusion criteria: willingness to participate in the study; diagnosed with anxiety disorders by psychologist and psychiatric; Their first diagnosis is anxiety disorder; not do any other psychotherapy along with this intervention. Exclusion criteria: Dependence on drugs and alcohol; Having a specific disease
Intervention groups
Intervention group: participants receive Tsessions and Trauma Releasing exercises (TRE) individually or in group. Intervention lasts 4 to 6 weeks. The sessions are twice a week and each session will be about an hour.
Main outcome variables
Anxiety score in Beck anxiety questionnaire; Mindfulness score in Baer's five-factor questionnaire
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230617058502N2
Registration date:2024-03-10, 1402/12/20
Registration timing:prospective
Last update:2024-03-10, 1402/12/20
Update count:0
Registration date
2024-03-10, 1402/12/20
Registrant information
Name
Leila Khabir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3641 0041
Email address
leila.khabir@iau.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-03, 1403/01/15
Expected recruitment end date
2024-05-19, 1403/02/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the effectiveness of Tension and Trauma Releasing Exercises (TRE) on psychological symptoms and mindfulness in individual with anxiety disorders
Public title
Effectiveness of Tension and Trauma Releasing Exercises (TRE) in anxiety disorders.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Willingness to participate in the study
Diagnosed with anxiety disorders by psychologist and psychiatrist
Their first diagnosis is anxiety disorder
Not do any other psychotherapy along with this intervention
Exclusion criteria:
Dependence on drugs and alcohol
Having a specific disease
Age
From 18 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
Research Ethics Committee of Islamic Azad University-Shiraz Branch
Street address
Faculty of Dentistry, 14th Alley, South Qa'ani street
City
Shiraz
Province
Fars
Postal code
00000000
Approval date
2024-01-24, 1402/11/04
Ethics committee reference number
IR.IAU.SHIRAZ.REC.1402.292
Health conditions studied
1
Description of health condition studied
Anxiety disorders
ICD-10 code
F41
ICD-10 code description
Other anxiety disorders
Primary outcomes
1
Description
Anxiety score in beck anxiety questionnaire
Timepoint
Assessing the anxiety level of the participants before and immediately after intervention, and one month after the end of intervention
Method of measurement
Beck anxiety questionnaire
2
Description
Mindfulness score in Baer's five-factor mindfulness questionnaire
Timepoint
Assessing the mindfulness level of participation before and immediately after intervention and one month after the end of intervention
Method of measurement
Baer's five-factor mindfulness questionnaire
Secondary outcomes
1
Description
Depression score in DASS 21 questionnaire
Timepoint
Before intervention and exactly after the intervention and one month after the end of the intervention.
Method of measurement
DOSS 21 questionnaire
Intervention groups
1
Description
Intervention group:Tension and Trauma Releasing Exercises (TRE) is done in 3 stages. The first stage, after performing 6 stretching exercises, in the 7th exercise, the neurogenic tremor in the legs are performed by the subject, and during this period, the person is given a rest at a certain time interval. In the second stage, after stretching exercises, the neurogenic tremor are directed to other parts of the body. In the third stage the tremor are completely directed to the whole body, and in each stage, after the end of the exercises, the subject is placed in a relaxed state so that the vibration are completely discharged. According to the subject's reaction to the exercises, the intervention time continues between 4 and 6 weeks. Throughout the stages, subject experiences mindfulness by focusing on breathing. Before and after each stage, the questionnaires is filled by subject and stress and anxiety level is determined by recording the score. All training steps will be done under the direct supervision of the trainer.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Roshd psychology clinic
Full name of responsible person
Dr.leila Khabir
Street address
N.568, 31 alley, Qasraldasht avenue
City
Shiraz
Province
Fars
Postal code
00000
Phone
+98 71 3233 3440
Email
Clinic.roshd2@gmail.com
2
Recruitment center
Name of recruitment center
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Leila Khabir
Street address
The central building, Zand street
City
Shiraz
Province
Fars
Postal code
00000
Phone
+98 71 3230 5410
Email
Info@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amir Shamsnia
Street address
Islamic Azad University Shiraz Branch, 5th Km of Sadra Highway
City
Shiraz
Province
Fars
Postal code
00000
Phone
+98 71 3619 1547
Email
l.Khabir@shirazu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Islamic Azad University of Shiraz
Proportion provided by this source
1
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Roya Shirali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Parsa complex, 15 alley, Eram Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۴۳۶۳۴۴۷۶
Phone
+98 71 3226 3029
Email
royashiralii@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Leila Khabir
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Islamic Azad University Shiraz Branch 5th Km Of Sadra Highway
City
Shiraz
Province
Fars
Postal code
0000
Phone
00000
Email
I.Khabir@shirazu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Roya Shirali
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Unit 1, Parsa complex, 15 alley, Eram Blvd
City
Shiraz
Province
Fars
Postal code
۷۱۴۳۶۳۴۴۷۶
Phone
+98 71 3226 3029
Email
royashiralii@gmail.com
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
No - There is not 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