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Comparison of the efficacy of face-to-face and online Transdiagnostic therapy on anxiety severity,related transdiagnostic factors and therapeutic alliance in people with Sub-clinical symptoms of anxiety disorders

Protocol summary

Study aim
Comparison of the efficacy of face-to-face and online Transdiagnostic therapy on anxiety severity ,related transdiagnostic factors and therapeutic alliance in people with Sub-clinical symptoms of anxiety disorders
Design
The clinical trial will be randomized using the rand function of Excel software
Settings and conduct
The intervention is individual and will be done in 12 sessions. Sessions will last 45 minutes. According to the protocol, the medals will be implemented as well as the number of sessions determined for each medal.
Participants/Inclusion and exclusion criteria
having subclinical anxiety symptoms based on Beck's anxiety questionnaire (scoring 8-25) age range between 18-50 years not suffering from severe psychiatric disorders (psychotic spectrum, bipolar disorder) not consuming drugs and alcohol in the last three months Not receiving cognitive-behavioral interventions for at least eight sessions in the last five years not receiving drug therapy within a month before the start of the intervention the interest of the participants to participate in the research based on the provisions of the written consent؛ Having drug or alcohol addiction suffering from severe psychiatric disorders (schizophrenia and bipolar disorder)
Intervention groups
In this study, 12 45-minute therapy sessions will be conducted for the members of the intervention group. In the first intervention group, these sessions will be held in person, and in the second group, they will be held online. The main focus in the sessions is on cognitive reconstruction, awareness of bodily sensations, awareness of the present moment, teaching the concepts of contradictory behavior and the three components of emotion, which include thoughts, bodily sensations, and behavior.
Main outcome variables
Anxiety intensity, anxiety sensitivity, negative repetitive thoughts, positive and negative affect and therapeutic alliance

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230117057142N1
Registration date: 2023-02-09, 1401/11/20
Registration timing: prospective

Last update: 2023-02-09, 1401/11/20
Update count: 0
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
Zeinab Hasanpour pirbasti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 13 3456 3284
Email address
zeinabhassanpour78@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-03-08, 1401/12/17
Expected recruitment end date
2023-06-20, 1402/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy of face-to-face and online Transdiagnostic therapy on anxiety severity,related transdiagnostic factors and therapeutic alliance in people with Sub-clinical symptoms of anxiety disorders
Public title
Comparison the effectiveness of face-to-face and online psychotherapy on mild anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
having subclinical anxiety symptoms based on Beck's anxiety questionnaire (scoring 8-25) age range between 18-50 years not suffering from severe psychiatric disorders (psychotic spectrum, bipolar disorder) not consuming drugs and alcohol in the last three months Not receiving cognitive-behavioral interventions for at least eight sessions in the last five years not receiving drug therapy within a month before the start of the intervention the interest of the participants to participate in the research based on the provisions of the written consent
Exclusion criteria:
Having drug or alcohol addiction suffering from severe psychiatric disorders (schizophrenia and bipolar disorder)
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Participant
Sample size
Target sample size: 44
Randomization (investigator's opinion)
Randomized
Randomization description
The samples are randomly assigned to two test groups. Random allocation is done using Excel software. For this purpose, in the first column, we enter 22 numbers 1 and 22 numbers 2 (respectively indicating the group (online and face-to-face integrative meta-diagnostic treatment group). Then in the second column, we generate 44 random numbers using the RAND() function. The data Based on the column values, we include random numbers sorted (ascending or descending). With this sorting, the order of placement of numbers 1 and 2 will also change and be placed randomly. Based on the order of appearance of numbers 1 and 2, the samples are assigned to two groups.
Blinding (investigator's opinion)
Single blinded
Blinding description
None of the subjects will be informed about the randomization and interpretation process of the groups.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research Ethics Committee of Zanjan University of Medical Sciences
Street address
Zanjan University of Medical Sciences , Mahdavi Blv, shahrak karmandan
City
zanjan
Province
Zanjan
Postal code
4513956184
Approval date
2023-01-11, 1401/10/21
Ethics committee reference number
IR.ZUMS.REC.1401.298

Health conditions studied

1

Description of health condition studied
Social phobias
ICD-10 code
F40.1
ICD-10 code description
Social phobias

2

Description of health condition studied
Panic disorder [episodic paroxysmal anxiety] without agoraphobia
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia

3

Description of health condition studied
Generalized anxiety disorder
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

4

Description of health condition studied
Other mixed anxiety disorders
ICD-10 code
F41.3
ICD-10 code description
Other mixed anxiety disorders

5

Description of health condition studied
Phobic anxiety disorders
ICD-10 code
F40
ICD-10 code description
Phobic anxiety disorders

6

Description of health condition studied
Agoraphobia, unspecified
ICD-10 code
F40.00
ICD-10 code description
Agoraphobia, unspecified

Primary outcomes

1

Description
Score in Beck's Anxiety Questionnaire
Timepoint
The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the interventionبرای
Method of measurement
Beck's anxiety questionnaire will be used for the variable of anxiety, and the subject's score in the range of 8-25 indicates the presence of subclinical symptoms of anxiety.

Secondary outcomes

1

Description
Repetitive negative thoughts: their main characteristic is being repetitive, disturbing and unwanted.
Timepoint
The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the intervention
Method of measurement
For the Repetitive negative thoughts variable, the Repetitive negative thoughts questionnaire will be used, which includes 10 questions.

2

Description
Anxiety sensitivity
Timepoint
The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the intervention
Method of measurement
The anxiety sensitivity questionnaire is a 16-item self-report questionnaire. The said questionnaire has 16 items and 3 subscales: physical concerns, fear of losing cognitive control, and fear of anxiety being observed by others.

3

Description
Positive and Negative Affect
Timepoint
The measurement will be done in three periods: before the intervention and after the end of the intervention and three months after the end of the intervention
Method of measurement
The positive and negative affect scale is a 20-word instrument designed to measure two mood dimensions, namely positive affect and negative affect.

4

Description
therapeutic alliance
Timepoint
The client and therapist versions of the therapeutic alliance Questionnaire are completed in the 6th session and the 12th session.
Method of measurement
The Work Alliance Questionnaire is a questionnaire that includes two forms, client and therapist versions. Each version contains 12 questions and is scored on a Likert scale from 1 to 5. One of the most common tools for evaluating the quality of therapeutic alliance is the working alliance questionnaire

Intervention groups

1

Description
The first intervention group face-to-face Transdiagnostic treatment group: The intervention will be implemented face-to-face and based on the Transdiagnostic therapy (Unified protocol) for adults. This protocol has 8 modules that will be implemented in 12 sessions. The protocol modules are 1 (goal selection and maintaining motivation) 2 (understanding emotions) 3 (mindfulness of emotion) 4 (cognitive flexibility) 5 (emotional behavior) 6 (understanding and dealing with bodily sensations) 7 (facing with excitement) 8 (reviewing skills and moving towards goals and maintaining achievements). The main focus of the protocol is on emotion and its three basic components, namely thoughts, physical sensations, and behavior. In the component of thoughts, the focus is on training mental errors and cognitive restructuring. In the component of bodily sensations, the techniques of awareness of bodily sensations are implemented. In the behavior component, training on the concepts of initiation and conflicting behavior is given. Finally, coping techniques with situational emotions and behavioral tests will be performed. Modals will be implemented during 12 sessions of 45 minutes for approximately 6 weeks. These modules will be distributed in the sessions according to the client's understanding and acceptance of the concepts and problems related to the preclinical symptoms of anxiety disorder, which is unique for each client.
Category
Treatment - Other

2

Description
The second intervention group, the online Transdiagnostic treatment group: the intervention will be implemented online and based on the Transdiagnostic therapy (Unified protocol) for adults.This protocol has 8 modules that will be implemented in 12 sessions. The protocol modules are 1 (goal selection and maintaining motivation) 2 (understanding emotions) 3 (mindfulness of emotion) 4 (cognitive flexibility) 5 (emotional behavior) 6 (understanding and dealing with bodily sensations) 7 (facing with excitement) 8 (reviewing skills and moving towards goals and maintaining achievements). The main focus of the protocol is on emotion and its three basic components, namely thoughts, physical sensations, and behavior. In the component of thoughts, the focus is on training mental errors and cognitive restructuring. In the component of bodily sensations, the techniques of awareness of bodily sensations are implemented. In the behavior component, training on the concepts of initiation and conflicting behavior is given. Finally, coping techniques with situational emotions and behavioral tests will be performed. Modals will be implemented during 12 sessions of 45 minutes for approximately 6 weeks. These modules will be distributed in the sessions according to the client's understanding and acceptance of the concepts and problems related to the preclinical symptoms of anxiety disorder, which is unique for each client.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Beheshti hospital
Full name of responsible person
zeinab hasanpour pirbasti
Street address
Ark Gate
City
zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
zeinabhassanpour78@gmail.com

2

Recruitment center
Name of recruitment center
Suhrvardi Clinic
Full name of responsible person
zeinab hasanpour pirbasti
Street address
Ark Gate
City
zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
zeinabhassanpour78@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Hasan Bakhtiari
Street address
Zanjan University of Medical Sciences, Mahdavi Blvd, sharak karmandan
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
hbakhtiary@zums.ac.ir
Web page address
http://zums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Sciences
Full name of responsible person
zeinab hasanpour pirbasti
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Gate ,Dr. Beheshti Hospital
City
zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
zeinabhassanpour78@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
zeinab hasanpour pirbasti
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Gate, Dr. Beheshti Hospital
City
zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
zeinabhassanpour78@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
zeinab hasanpour pirbasti
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Ark Gate, Dr. Beheshti Hospital
City
zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
zeinabhassanpour78@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
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
Undecided - It is not yet known if there will be 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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