Comparison of Group Transdiagnostic Treatment (Unified Protocol) in Face-to-Face and Online Formats on Emotion Regulation, Experiential Avoidance, Social Adjustment, and Resilience in Students with Test Anxiety.
The study aims to compare the effectiveness of both face-to-face and online transdiagnostic group therapy on test anxiety in students, focusing on emotion regulation, experiential avoidance, social adjustment, and resilience.
Design
This clinical trial has a control group, with parallel groups, double-blind, and randomized, conducted on 60 female students in grades 10 to 12 in the city of Zanjan. Web-based randomization was used to ensure a fair distribution of participants in the treatment and control groups.
Settings and conduct
This study is a double-blind clinical trial conducted in Zanjan city among female high school students in grades 10 to 12. After obtaining the necessary approvals and randomly selecting schools, 60 students with moderate to severe test anxiety are divided into three groups: in-person treatment, online treatment, and control. Data collectors and outcome assessors remain unaware of group assignments to maintain objectivity and accuracy of the results.
Participants/Inclusion and exclusion criteria
Inclusion Criteria
Age: 15 to 18 years
Moderate to severe test anxiety
No severe psychiatric disorders
No psychotherapy received in the past year
Stability of effective medications (if applicable)
Exclusion Criteria
Absence from more than two consecutive sessions
Lack of satisfaction with treatment
Worsening of individual problems
Non-participation in assessment stages
Intervention groups
Face-to-Face Transdiagnostic Treatment Group: In-person sessions focus on managing exam anxiety and enhancing emotional skills using the UP protocol.
Online Transdiagnostic Treatment Group: Similar content delivered via Google Meet.
Control Group: Participants receive no intervention during the study period.
Main outcome variables
reduce test anxiety and experiential avoidance ,Improving emotion regulation skills, Increasing social adjustment and resilience in students
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250121064456N1
Registration date:2025-01-24, 1403/11/05
Registration timing:prospective
Last update:2025-01-24, 1403/11/05
Update count:1
Registration date
2025-01-24, 1403/11/05
Registrant information
Name
Iran Andaroon
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3501 2534
Email address
andaroonnegin80@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-04-09, 1404/01/20
Expected recruitment end date
2026-03-11, 1404/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Group Transdiagnostic Treatment (Unified Protocol) in Face-to-Face and Online Formats on Emotion Regulation, Experiential Avoidance, Social Adjustment, and Resilience in Students with Test Anxiety.
Public title
Comparison the effectiveness of face-to-face and online psychotherapy on test anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
1.Participants must be between the ages of 15 and 18.
2.They should experience moderate to severe test anxiety.
3.Participants must have no history of severe psychiatric disorders.
4.They should not have received psychotherapy in the past year.
5.If applicable, participants must have stable psychotropic medication.
6.Access to the internet via a computer or electronic tablet is required.
7.Informed consent must be obtained from participants for their participation in the study, as outlined in the written consent form
Exclusion criteria:
1.Having Autism Spectrum Disorder.
2.Having a chronic illness.
Age
From 15 years old to 18 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
This study is a parallel-group, double-blind, randomized controlled trial, targeting female students in grades 10 to 12 in Zanjan City. In this section, we will provide a detailed explanation of the randomization process using web-based randomization.
1. Randomization Method
•Cluster Randomization Method: Initially, two districts of Zanjan City will be randomly selected through cluster sampling. Subsequently, two schools will be chosen from the existing schools in these districts via a lottery system. This selection will be conducted in a manner that ensures all schools in these districts have an equal chance of being chosen.
2. Randomization Units
•Randomization Units: In this study, the randomization units are the students who will be allocated to different treatment groups. After distributing the Sarason and Spielberger Anxiety Questionnaire, 60 students with moderate (scores 13 to 20) and severe (score 20) test anxiety will be randomly selected.
3. Stratified Randomization
•Stratified Randomization: Stratified randomization will not be employed in this study. However, if necessary, we could create various strata based on characteristics such as anxiety levels or age.
4. Randomization Tool
•Web-Based Randomization: To generate the random sequence, web-based randomization will be utilized. This tool allows for the production of random numbers and the random assignment of individuals to different groups online, ensuring transparency. This method helps reduce bias in allocation and ensures that each participant is randomly assigned to one of the treatment groups.
5. Random Sequence Generation
•Random Sequence: After the final selection of 60 participants, these individuals will be randomly divided into three treatment groups using web-based randomization: the online integrative diagnostic treatment group, the in-person integrative diagnostic treatment group, and the waitlist control group.
6. Allocation Concealment
•Allocation Concealment: To ensure that there is no influence on the allocation of participants to groups, the information regarding group assignments will be kept concealed from both the researchers and the treatment group members. This will be achieved through web-based randomization, and the information about group assignments will only be accessible after the allocation process is completed
Blinding (investigator's opinion)
Double blinded
Blinding description
Blinding of Data Collectors
Individuals responsible for data collection will remain unaware of the group assignments. This ensures that the data collection process is conducted without bias.
Blinding of Outcome Assessors
Those evaluating the results of the study will also be blind to the group assignments. This is crucial for maintaining objectivity in the assessment of outcomes.
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
2025-01-21, 1403/11/02
Ethics committee reference number
IR.ZUMS.REC.1403.287
Health conditions studied
1
Description of health condition studied
test anxiety
ICD-10 code
F40.1
ICD-10 code description
(اختلال اضطراب اجتماعی )
Primary outcomes
1
Description
test anxiety
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 variable of test anxiety, a test anxiety questionnaire comprising 37 items will be utilized.
Secondary outcomes
1
Description
emotion regulation
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
Difficulties in Emotion Regulation Scale (DERS):This scale was developed in 2004 by Gratz and Roemer with 36 items to assess the level of emotional dysregulation and to evaluate self-regulation strategies.
2
Description
Experiential avoidance
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
This questionnaire was developed by Bond et al. in 2011 with 10 items to assess experiential avoidance.
3
Description
social adjustment
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
Social Adjustment Questionnaire for Students (AISS29):This questionnaire was developed by Sinha and Singh in 1993 and consists of 20 items to measure social adjustment.
4
Description
resilience
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
Connor-Davidson Resilience Scale (CD-RISC):The Connor-Davidson Resilience Scale consists of 25 items rated on a Likert scale from 0 (not true at all) to 5 (true nearly all the time).
Intervention groups
1
Description
Intervention group: The first intervention group will implement the face-to-face group therapy based on the Transdiagnostic Protocol (unified protocol) for adolescents. This protocol consists of 8 modalities and will be conducted over 12 sessions. The modalities of the protocol are as follows: Goal setting and motivation maintenance Understanding emotions Emotion awareness Cognitive flexibility Emotional behavior Understanding and confronting physical sensations Confronting emotions Reviewing skills and progressing towards goals while maintaining achievements The main focus of the protocol is on emotions and its three essential components: thoughts, bodily sensations, and behaviors. In the thoughts component, the focus is on teaching cognitive distortions and cognitive restructuring. In the bodily sensations component, techniques for awareness of physical sensations will be implemented. In the behavior component, concepts of triggers and opposing behaviors will be taught. Finally, techniques for confronting situational emotions and behavioral experiments will be conducted. The modalities will be carried out in 12 group sessions, each lasting 90 minutes.
Category
Treatment - Other
2
Description
Intervention group: The second intervention group will implement the online group therapy based on the Transdiagnostic Protocol (unified protocol) for adolescents using Google Meet. This protocol consists of 8 modalities and will be conducted over 12 sessions. The modalities of the protocol are as follows: Goal setting and motivation maintenance Understanding emotions Emotion awareness Cognitive flexibility Emotional behavior Understanding and confronting physical sensations Confronting emotions Reviewing skills and progressing towards goals while maintaining achievements The main focus of the protocol is on emotions and its three essential components: thoughts, bodily sensations, and behaviors. In the thoughts component, the focus is on teaching cognitive distortions and cognitive restructuring. In the bodily sensations component, techniques for awareness of physical sensations will be implemented. In the behavior component, concepts of triggers and opposing behaviors will be taught. Finally, techniques for confronting situational emotions and behavioral experiments will be conducted. The modalities will be carried out in 12 sessions, each lasting 90 minutes.
Category
Treatment - Other
3
Description
Control group: Control Group:In the control group, no intervention will be conducted. Participants will wait for treatment while monitoring the effectiveness of the therapy on reducing test anxiety.
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Schools in Zanjan City
Full name of responsible person
negin andaroon
Street address
darvazeh ark
City
zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
andaroonnegin80@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Mehrdad Hamidi
Street address
Zanjan University of Medical Sciences, Mahdavi Blvd, sharak karmandan
City
zanjan
Province
Zanjan
Postal code
4513956184
Phone
+98 24 3301 8100
Email
hamidim@sums.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
Negin Andaroon
Position
Master's Student
Latest degree
A Level or less
Other areas of specialty/work
Psychology
Street address
Darvazeh Ark ,Dr. Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
andaroonnegin80@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Negin Andaroon
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Darvazeh Ark, Dr. Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
andaroonnegin80@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Negin Andaroon
Position
Master's Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Darvazeh Ark, Dr. Beheshti Hospital
City
Zanjan
Province
Zanjan
Postal code
1578845136
Phone
+98 24 3354 4001
Email
andaroonnegin80@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
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