Protocol summary
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Study aim
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The study aims to investigate the effectiveness of face-to-face transdiagnostic group therapy on test anxiety in students, focusing on emotion regulation, experiential avoidance, social adjustment, and resilience."
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Design
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This study is a parallel-group, double-blind (assessor and statistical analyst-blinded), randomized controlled trial conducted on 40 female students in grades 10 to 12 in Zanjan City. Web-based randomization was utilized for the randomization process in this study."
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Settings and conduct
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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, 40 students with moderate to severe test anxiety are divided into two groups: in-person treatment, and waitlist contrl group.Data collectors and outcome assessors remain unaware of group assignments to maintain objectivity and accuracy of the results.
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Participants/Inclusion and exclusion criteria
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Inclusion Criteria
Age: 15 to 18 years
Moderate to severe test anxiety
No severe psychiatric disorders
No Cognitive Behavioral Therapy (CBT) received in the past five years.
Stability of effective medications (if applicable)
Exclusion Criteria
Absence from more than three consecutive sessions
Lack of satisfaction with treatment
Worsening of individual problems
Non-participation in assessment stages
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Intervention groups
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Face-to-Face Transdiagnostic Treatment Group: In-person sessions focus on managing exam anxiety and enhancing emotional skills using the UP
Control Group: Participants receive no intervention during the study period.
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Main outcome variables
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reduce test anxiety and experiential avoidance ,Improving emotion regulation skills, Increasing social adjustment and resilience in students
General information
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Reason for update
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Due to the lack of approval from the Ministry of Education (or: educational authorities) to conduct the protocol online, the protocol was implemented solely face-to-face."
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20250121064456N1
Registration date:
2025-01-24, 1403/11/05
Registration timing:
prospective
Last update:
2025-06-01, 1404/03/11
Update count:
1
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Registration date
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2025-01-24, 1403/11/05
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2025-04-09, 1404/01/20
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Expected recruitment end date
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2026-03-11, 1404/12/20
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Effectiveness of face-to-face Transdiagnostic Treatment (Unified Protocol) on Emotion Regulation, Experiential Avoidance, Social Adjustment, and Resilience in Students with Test Anxiety
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Public title
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effectiveness of face-to-face psychotherapy on test anxiety
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Purpose
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Education/Guidance
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Inclusion/Exclusion criteria
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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 cognitive-behavioral therapy in the past five years
5.If applicable, participants must have stable psychotropic medication.
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.
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Age
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From 15 years old to 18 years old
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Gender
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Female
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Phase
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N/A
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Groups that have been masked
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- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
60
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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This study is a parallel-group, double-blind (assessor and analyst-blinded), 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.
Randomization Method (Sampling & Screening)
Cluster Sampling & Screening: Initially, two city districts and then two schools will be randomly selected. Students will be screened using the Sarason Test Anxiety Questionnaire, followed by K-SADS-PL diagnostic interviews for those with moderate (scores 13-20) or severe (score 20+) anxiety.
Randomization Units and Selection
Randomization Units: Eligible students are the units. From the screened pool, 40 eligible students will be randomly selected using web-based randomization and will complete baseline questionnaires (Sarason, STAI, DERS, AAQ-II, Sinha & Singh Adjustment, CD-RISC).
Stratified Randomization
Stratified Randomization: Stratified randomization will not be employed in this study. However, if necessary, strata based on characteristics like anxiety levels or age could be considered.
Randomization Tool
Web-Based Randomization: Web-based randomization will be utilized for both the random selection of the 40 participants and their subsequent random assignment. This tool ensures transparent, online, bias-reducing allocation.
Random Sequence Generation and Group Allocation
Random Sequence & Allocation: After selection and baseline assessment, the 40 participants will be randomly assigned via web-based randomization to one of two groups: the in-person transdiagnostic integrative therapy group (n=20) or the waitlist control group (n=20). The in-person group will be divided into two sub-groups of 10 for facilitation.
Allocation Concealment and Blinding
Allocation Concealment & Blinding: The web-based randomization sequence will be concealed until assignment. Outcome assessments will be by a blind assessor, and data analysis by a blind analyst. Therapists and participants will be aware of group assignments.
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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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.
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Placebo
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Not used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2025-01-21, 1403/11/02
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Ethics committee reference number
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IR.ZUMS.REC.1403.287
Health conditions studied
1
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Description of health condition studied
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test anxiety
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ICD-10 code
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F40.1
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ICD-10 code description
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(اختلال اضطراب اجتماعی )
Primary outcomes
1
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Description
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test anxiety
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Timepoint
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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
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Method of measurement
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For the variable of test anxiety, a test anxiety questionnaire comprising 37 items will be utilized.
Secondary outcomes
1
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Description
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emotion regulation
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Timepoint
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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
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Method of measurement
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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
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Description
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Experiential avoidance
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Timepoint
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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
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Method of measurement
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This questionnaire was developed by Bond et al. in 2011 with 10 items to assess experiential avoidance.
3
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Description
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social adjustment
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Timepoint
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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
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Method of measurement
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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
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Description
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resilience
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Timepoint
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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
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Method of measurement
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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
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Description
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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.
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Category
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Treatment - Other
2
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Description
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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.
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Category
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N/A
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Zanjan University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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No - There is not a plan to make this available
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Data Dictionary
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No - There is not a plan to make this available