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IRCT20261020071507N1 IRCT 2026-11-07 Islamic Azad University Investigating the Effect of a Cognitive-Behavioral Intervention on Cognitive Components in Female University Students with Future Anxiety The Effectiveness of Cognitive-Behavioral Therapy-Based Intervention on Cognitive Flexibility, Intolerance of Uncertainty, and Rumination in Female Students with Future Anxiety at Islamic Azad University 2026-11-11 anticipated 40 Pending https://irct.ir/trial/94222 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: The study population consists of female students at the Islamic Azad University who experience anxiety about the future and visit the university’s counseling center during the designated study period. A convenience sampling method will be employed to select the sample. Once a sample of 40 participants is selected based on the study’s inclusion and exclusion criteria, they will be randomly assigned to either an "intervention group" (receiving a cognitive-behavioral therapy-based intervention) or a "control group" (placed on a waiting list). Randomization will be conducted using a permuted-block design with varying block sizes (4 and 6) by an independent statistician who is not involved in the study's implementation. The randomization sequence will be generated using the RAND function in Microsoft Excel and placed into opaque, sealed, and numbered envelopes to ensure that neither the researcher nor the participants are aware of the allocation sequence (allocation concealment). The envelopes will be opened—revealing the assigned group—only at the time each participant enters the study. To ensure the comparability of baseline variables (such as anxiety levels and age) between the two groups, their distribution will be examined during the statistical analysis phase. N/A Anxiety disorders related to the future. Intervention 1: Intervention group: Duration of each session: 90 minutes. Total number of sessions: 8. Frequency: Twice weekly. Therapeutic tools: This intervention is based on a standard Cognitive-Behavioral Therapy (CBT) protocol. Key components include: guided talk therapy; cognitive assessment and restructuring of catastrophic thoughts regarding the future; mindfulness and muscle relaxation techniques; methods to enhance cognitive flexibility; exposure to uncertainty; and strategies to interrupt negative automatic thoughts and rumination. Intervention content: Session 1: Pre-testing, participant introductions, explanation of the CBT rationale, exploration of the nature of future-oriented anxiety, and identification of maladaptive thought patterns. Session 2: Training on how to identify and record negative automatic thoughts and cognitive distortions related to future uncertainties, and examining the interplay between thoughts, emotions, and behaviors. Session 3: Instruction and application of cognitive restructuring techniques to challenge irrational beliefs and foster cognitive flexibility. Session 4: Utilization of mindfulness techniques and a focus on the present moment to reduce rumination and future-oriented worries. Session 5: Practicing exposure to uncertainty, developing problem-solving skills, and mentally engaging with ambiguous future scenarios to increase tolerance for uncertainty. Session 6: Examining cognitive and behavioral barriers to change, and analyzing the factors that maintain rumination and anxiety about the future. Session 7: Instruction in relaxation techniques, along with a review and consolidation of the cognitive-behavioral skills learned for managing daily stressors. Session 8: Summarizing the sessions, reviewing group achievements, assigning relapse-prevention tasks, administering the post-test, and establishing a specific schedule for the follow-up assessment. Intervention 2: Control group: The control group will not receive any intervention during the conduct of the study; however, to prevent threats to the study's internal validity—such as compensatory rivalry or demoralization—they will receive the intervention after the data collection phase. 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 As the research has not yet commenced and no data is available, it is not possible to publish any data. I will proceed with the publication of the data once these issues have been resolved.
public Elaheh Bayramzadeh
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
Ahvaz Iran (Islamic Republic of) 6134937333 +98 61 3334 8421 elahe.bairamzadeh@iau.ir Islamic Azad University scientific Elaheh Bayramzadeh
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
Ahvaz Iran (Islamic Republic of) 6134937333 +98 61 3334 8421 elahe.bairamzadeh@iau.ir Islamic Azad University Iran (Islamic Republic of) Being enrolled at the Islamic Azad University Being a female student aged 18 to 30 Scoring above the standard cut-off point on the Future Anxiety Questionnaire, indicating a high level of future anxiety 18 years 30 years Female Presence of acute psychiatric or psychotic disorders, based on clinical interview or self-report Concurrent participation in other psychotherapy sessions or workshops related to the research variables within the 3 months prior to the start of the study Current history of substance or alcohol abuse F41.1 Generalized anxiety disorder Treatment - Other Treatment - Other Intervention group: Duration of each session: 90 minutes. Total number of sessions: 8. Frequency: Twice weekly. Therapeutic tools: This intervention is based on a standard Cognitive-Behavioral Therapy (CBT) protocol. Key components include: guided talk therapy; cognitive assessment and restructuring of catastrophic thoughts regarding the future; mindfulness and muscle relaxation techniques; methods to enhance cognitive flexibility; exposure to uncertainty; and strategies to interrupt negative automatic thoughts and rumination. Intervention content: Session 1: Pre-testing, participant introductions, explanation of the CBT rationale, exploration of the nature of future-oriented anxiety, and identification of maladaptive thought patterns. Session 2: Training on how to identify and record negative automatic thoughts and cognitive distortions related to future uncertainties, and examining the interplay between thoughts, emotions, and behaviors. Session 3: Instruction and application of cognitive restructuring techniques to challenge irrational beliefs and foster cognitive flexibility. Session 4: Utilization of mindfulness techniques and a focus on the present moment to reduce rumination and future-oriented worries. Session 5: Practicing exposure to uncertainty, developing problem-solving skills, and mentally engaging with ambiguous future scenarios to increase tolerance for uncertainty. Session 6: Examining cognitive and behavioral barriers to change, and analyzing the factors that maintain rumination and anxiety about the future. Session 7: Instruction in relaxation techniques, along with a review and consolidation of the cognitive-behavioral skills learned for managing daily stressors. Session 8: Summarizing the sessions, reviewing group achievements, assigning relapse-prevention tasks, administering the post-test, and establishing a specific schedule for the follow-up assessment. Control group: The control group will not receive any intervention during the conduct of the study; however, to prevent threats to the study's internal validity—such as compensatory rivalry or demoralization—they will receive the intervention after the data collection phase. Cognitive Flexibility. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: The Cognitive Flexibility Questionnaire by Dennis and Vander Wal (2010) will be used to assess cognitive flexibility. Tolerance of Uncertainty. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: To assess intolerance of uncertainty, the Intolerance of Uncertainty Scale by Freeston et al. (1994) will be used. Rumination. Timepoint: 1. Pre-test (before the start of the intervention) 2. Post-test (immediately after the end of the intervention period) 3. One-month follow-up after the intervention. Method of measurement: To assess rumination, the Ruminative Responses Scale by Nolen-Hoeksema and Morrow (1991) will be used. Islamic Azad University Approved 2026-10-13 Ethics Committee of Islamic Azad University, Ahvaz Opposite Keshavarz Street, Farhang Shahr, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)