assessing feasibility, efficacy and effectiveness of Norton TGCBT
Design
The clinical trial uses a sample of 20 patients with anxiety disorders in two matched groups, intervention and control.
Settings and conduct
This clinical trial is conducted in Tehran using a quasi-experimental method with pre-test-post-test, follow-up phase and control group.
Participants/Inclusion and exclusion criteria
Possessing the psychological skill of speaking and understanding the Persian language;- receiving DSM-5-TR diagnostic criteria for at least one of generalized anxiety disorder, social anxiety disorder, panic attack, transphobia, or specific phobia based on the Structured Clinical Interview for DSM-5 Disorders (SCID-5);- Acceptance of the conditions contained in the treatment contract.- Absence of active suicide intention;- Not suffering from disorders related to drug use;- lack of conflict with issues requiring immediate intervention;- Failure to receive psychiatric treatment during the last 12 months or stability in medication regimen throughout the protocol implementation period in participants who take medication;- Failure to receive psychological treatment at the same time as the protocol implementation period;- Absence of suffering from disorders: spectrum of schizophrenia and psychosis; bipolar; depression; cognitive impairment; anxiety caused by the use of drugs/medication or related to other medical conditions; compatibility; physical symptoms; disease anxiety; Distortion of the body; obsession - incontinence; disorders related to trauma and stress; separation anxiety; Personality disorders.
Intervention groups
intervention group
control group
Main outcome variables
anxiety symptoms
General information
Reason for update
Acronym
TGCBT
IRCT registration information
IRCT registration number:IRCT20240310061240N1
Registration date:2024-04-29, 1403/02/10
Registration timing:registered_while_recruiting
Last update:2024-04-29, 1403/02/10
Update count:0
Registration date
2024-04-29, 1403/02/10
Registrant information
Name
Fatemeh Akhavan-Abiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5121 2470
Email address
akhavan885@gmail.com
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-02-10, 1402/11/21
Expected recruitment end date
2025-06-21, 1404/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Norton Transdiagnostic Group Cognitive-Behavioral Therapy for Anxiety Disorders: Experts' Viewpoint on its Feasibility, Efficacy and Effectiveness
Public title
Norton Transdiagnostic Group Cognitive-Behavioral Therapy for Anxiety Disorders
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Possessing the psychological skill of speaking and understanding the Persian language;- receiving DSM-5-TR diagnostic criteria for at least one of generalized anxiety disorder, social anxiety disorder, panic attack, transphobia, or specific phobia based on the Structured Clinical Interview for DSM-5 Disorders (SCID-5);- Acceptance of the conditions contained in the treatment contract.- Absence of active suicide intention;- Not suffering from disorders related to drug use;- lack of conflict with issues requiring immediate intervention;- Failure to receive psychiatric treatment during the last 12 months or stability in medication regimen throughout the protocol implementation period in participants who take medication;- Failure to receive psychological treatment at the same time as the protocol implementation period;- Absence of suffering from disorders: spectrum of schizophrenia and psychosis; bipolar; depression; cognitive impairment; anxiety caused by the use of drugs/medication or related to other medical conditions; compatibility; physical symptoms; disease anxiety; Distortion of the body; obsession - incontinence; disorders related to trauma and stress; separation anxiety; Personality disorders.
Exclusion criteria:
- Client's non-compliance with the conditions of the treatment program; - Absence from treatment sessions for more than two sessions and not accompanying the client to the sessions, even after meeting to compensate for his absence; - Failure to complete the assessment procedures.
Age
From 18 years old to 45 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
22
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
Meeting No. 125 of Shahed University Ethics Working Group
Street address
Shahed University, Persian Gulf Freeway
City
Tehran
Province
Tehran
Postal code
3319118651
Approval date
2024-02-10, 1402/11/21
Ethics committee reference number
IR.SHAHED.RES1402.126
Health conditions studied
1
Description of health condition studied
Anxiety Disorders
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder
Primary outcomes
1
Description
anxiety symptoms
Timepoint
pretest - post test - follow up
Method of measurement
self-rating tools
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Behavior
2
Description
Control group:
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahed University
Full name of responsible person
Fatemeh Akhavan-Abiri
Street address
Shahed University, Persian Gulf Freeway
City
تهران
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
publicrelation@shahed.ac.ir
2
Recruitment center
Name of recruitment center
505 AJA Hospital
Full name of responsible person
Fatemeh Akhavan-Abiri
Street address
Majdi Blvd, Artesh highway
City
Tehran
Province
Tehran
Postal code
1956944141
Phone
+98 21 2248 1806
Email
info@ajaums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahed University
Full name of responsible person
Fatemeh Akhavan-Abiri
Street address
Shahed University, Persian Gulf Freeway
City
تهران
Province
Tehran
Postal code
3319118651
Phone
+98 21 5121 5080
Email
publicrelation@shahed.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Private sector
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
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fatemeh Akhavan-Abiri
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
U. 21, No. 28, east 8th, Fakouri street, Punak
City
تهران
Province
Tehran
Postal code
1475985684
Phone
+98 21 4485 4653
Email
akhavan885@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fatemeh Akhavan-Abiri
Position
Student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
U. 21, No. 28, east 8th, Fakouri street, Punak
City
تهران
Province
Tehran
Postal code
1475985684
Phone
+98 21 4485 4653
Email
akhavan885@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahed University
Full name of responsible person
Fatemeh Akhavan-Abiri
Position
student
Latest degree
Master
Other areas of specialty/work
Psychology
Street address
U. 21, No. 28, east 8th, Fakouri street, Punak
City
تهران
Province
Tehran
Postal code
1475985684
Phone
+98 21 4485 4653
Email
akhavan885@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
Title and more details about the data/document
All data will be shared after unidentifying the participants
When the data will become available and for how long
from 6 months after publishing the findings
To whom data/document is available
all academic researchers
Under which criteria data/document could be used
all academic researchers
From where data/document is obtainable
Fatemeh Akhavan-Abiri
What processes are involved for a request to access data/document