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IRCT20250121064456N1 IRCT 2025-01-24 Zanjan University of Medical Sciences effectiveness of face-to-face psychotherapy on test anxiety Effectiveness of face-to-face Transdiagnostic Treatment (Unified Protocol) on Emotion Regulation, Experiential Avoidance, Social Adjustment, and Resilience in Students with Test Anxiety 2025-04-09 anticipated 60 Complete https://irct.ir/trial/81447 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: 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, 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. N/A test anxiety. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No further information is available.
public Negin Andaroon
Darvazeh Ark ,Dr. Beheshti Hospital
Zanjan Iran (Islamic Republic of) 1578845136 +98 24 3354 4001 andaroonnegin80@gmail.com Zanjan University of Medical Sciences scientific Negin Andaroon
Darvazeh Ark, Dr. Beheshti Hospital
Zanjan Iran (Islamic Republic of) 1578845136 +98 24 3354 4001 andaroonnegin80@gmail.com Zanjan University of Medical Sciences Iran (Islamic Republic of) 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 15 years 18 years Female 1.Having Autism Spectrum Disorder. 2.Having a chronic illness. F40.1 (اختلال اضطراب اجتماعی ) Treatment - Other N/A 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. 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. 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. 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. 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. 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. 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). Zanjan University of Medical Sciences Approved 2025-01-21 Research Ethics Committee of Zanjan University of Medical Sciences Zanjan University of Medical Sciences , Mahdavi Blv, shahrak karmandan zanjan Zanjan Iran (Islamic Republic of)