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Comparing the effectiveness of mindful interoceptive desensitization and behavioral exteroceptive desensitization in reducing the anxiety symptoms

Protocol summary

Study aim
Comparing the effectiveness of mindful interoceptive desensitization and behavioral exteroceptive desensitization in reducing the anxiety symptoms
Design
As a one-way blind randomized clinical trial intervention, all eligible individuals selected (at least 90 individuals), and randomly assigned to three groups. Each group will be evaluated before entering the study, after four intervention sessions, and finally two months after the intervention (follow-up). The first group will receive intervention based on MiCBT protocol, the second group will receive four session of systematic desensitization, and the third group will receive Jacobson's progressive muscle relaxation.
Settings and conduct
The study is performed in Tehran and in the psychology clinic of Taleghani Hospital. Meetings are held in-person and in accordance with the protocol, and in order not to create bias for participants, all individuals will receive medical intervention.
Participants/Inclusion and exclusion criteria
1) having the consent to participate in the study, 2) having a score of 16 in the Beck Anxiety Questionnaire, 3) not having psychotic symptoms or a recognizable psychotic disorder (assessed by a clinical psychologist), 4) not having an acute cognitive problem, 5) not participating in a Simultaneous psychological intervention, 6) not receiving medication for psychological problems, 7) not having suicidal thoughts Exclusion criteria: 1) need to be hospitalized or prescribed medication, 2) refusal to continue research
Intervention groups
The study groups consist of three groups, the first group will receive introceptive desensitization, the second group will receive extroceptive desensitization, and the third group will receive progressive muscle relaxation treatment as the active control group.
Main outcome variables
State-trait Anxiety Beck scale for anxiety Mindfulness Based Self-efficacy Sale SCL-90

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220113053705N1
Registration date: 2022-02-01, 1400/11/12
Registration timing: prospective

Last update: 2022-02-01, 1400/11/12
Update count: 0
Registration date
2022-02-01, 1400/11/12
Registrant information
Name
Fateh Sohrabi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 87 3371 8025
Email address
f.sohrabi20@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-02-20, 1400/12/01
Expected recruitment end date
2022-07-23, 1401/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effectiveness of mindful interoceptive desensitization and behavioral exteroceptive desensitization in reducing the anxiety symptoms
Public title
Comparing the effectiveness of mindful interoceptive desensitization and behavioral exteroceptive desensitization
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having the consent to participate in the study, having a score of 16 in the Beck Anxiety Inventory, not having psychotic symptoms or a recognizable psychotic disorder (assessed by a clinical psychologist), not having an acute cognitive problem, not participating in a Simultaneous psychological intervention, not receiving medication for psychological problems, not having suicidal thoughts
Exclusion criteria:
the necessity of hospitalization or proscribing medication being resentful for continuing the research
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 90
Randomization (investigator's opinion)
Randomized
Randomization description
All eligible individuals are assigned a code in the form of ordinal numbers and then randomly selected by drawing lots. the first of thirty subjects assigned to intervention group 1 (introversion desensitization), the second thirty to intervention group 2 (extroversion desensitization), And 30 people will be assigned to the active control group (progressive muscle relaxation).
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
research Ethicscommittees of school of medicine- Shahid Beheshti University of medical sciences
Street address
Next to Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Shahid Erabi St, Velenjak
City
Tehran
Province
Tehran
Postal code
1983969411
Approval date
2021-07-13, 1400/04/22
Ethics committee reference number
IR.SBMU.MSP.REC.1400.238

Health conditions studied

1

Description of health condition studied
Anxiety
ICD-10 code
F06.4
ICD-10 code description
Anxiety disorder due to known physiological condition

Primary outcomes

1

Description
State and Trait Anxiety: Measures the characteristics of persistent and unstable anxiety symptoms,
Timepoint
Participants will evaluated in the three level of time; Before the intervention (pre-test stage), after the intervention (post-test stage), and after the intervention (follow-up)
Method of measurement
State and Trait Anxiety Questionnaire,

2

Description
Beck anxiety; measures anxiety in general based on its symptoms,
Timepoint
Participants will evaluated in the three level of time; Before the intervention (pre-test stage), after the intervention (post-test stage), and after the intervention (follow-up)
Method of measurement
Beck Anxiety Scale,

3

Description
Mindfulness-based self-efficacy: Measures a person's sense of effectiveness based on symptoms (toward symptoms a\of anxiety),
Timepoint
Participants will evaluated in the three level of time; Before the intervention (pre-test stage), after the intervention (post-test stage), and after the intervention (follow-up)
Method of measurement
Mindfulness-Based Self-Efficacy Scale,

4

Description
Symptom Checklist-90 that also measure the total psychological symptoms other than anxiety.
Timepoint
Participants will evaluated in the three level of time; Before the intervention (pre-test stage), after the intervention (post-test stage), and after the intervention (follow-up)
Method of measurement
Symptoms Checklist 90 (SCL-90)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: This group receives 4 sessions of Mindfulness integrated Cognitive-Behavioral Therapy combined as a interoceptive desensitization program. in that, the process of desensitization will do according to the protocol.
Category
Treatment - Other

2

Description
Intervention group 2: This group, called the extroceptive desensitization group, receives 4 sessions of regular desensitization treatment, in which the extrinsic desensitization process is performed according to the treatment protocol.
Category
Treatment - Other

3

Description
Control group: This group, as an active control group, receives 4 sessions of progressive muscle relaxation treatment according to the treatment protocol of the relevant process.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Taleghani Hospital
Full name of responsible person
Fateh Sohrabi
Street address
Psychology Clinic of Taleghani Hospital, Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Velenjak.
City
Tehran
Province
Tehran
Postal code
1983969411
Phone
+98 918 992 6805
Email
f.sohrabi20@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Vice-Chancellor in Research Affairs, Shahid Beheshti University of Medical Sciences, Shahid Arabi St, Velenjak.
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2243 9781
Email
zarghi@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
Private
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 Bakhtyari
Position
Professor in Clinical Psychology
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
Taleghani Hospital, Erabi Ave, Daneshjoo Sq, Velenjak
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1548
Fax
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
Fateh Sohrabi
Position
PhD student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
1985711151
Phone
+98 87 3371 8025
Fax
Email
f.sohrabi20@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Fateh Sohrabi
Position
PhD student of clinical psychology
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
Pasdaran
City
Sanandaj
Province
Kurdistan
Postal code
1985711151
Phone
+98 87 3371 8025
Fax
Email
f.sohrabi20@gmail.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
There is no more information here
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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