Protocol summary

Study aim
The Effectiveness of a Cognitive-Behavioral Therapy-Based Intervention on Cognitive Flexibility, Intolerance of Uncertainty, and Rumination in Female University Students with Future-Related Anxiety at the Islamic Azad University
Design
A randomized, parallel-group, open-label, controlled clinical trial involving 40 patients. The `rand` function in Microsoft Excel will be used for randomization.
Settings and conduct
The statistical population for the present study consists of female students experiencing future-related anxiety at the Ahvaz Branch of the Islamic Azad University who visit the university’s "Amin" Counseling Center during the designated study period. A convenience sampling method will be employed to select the sample. Following the selection of 40 participants—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).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Female students aged 18 to 30 years who score above the standard cutoff point on the Future Anxiety Questionnaire, indicating a high level of future anxiety. Exclusion criteria: Presence of acute psychiatric disorders, psychotic disorders, or active suicidal ideation (based on clinical interview or self-report); current history of substance or alcohol abuse.
Intervention groups
Intervention group: All female students experiencing anxiety about the future who will receive an intervention based on cognitive-behavioral therapy. Control group: All female students experiencing anxiety about the future who will not receive any intervention.
Main outcome variables
Cognitive flexibility, Tolerance of Uncertainty, Rumination

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20261020071507N1
Registration date: 2026-11-07, 1405/08/16
Registration timing: prospective

Last update: 2026-11-07, 1405/08/16
Update count: 0
Registration date
2026-11-07, 1405/08/16
Registrant information
Name
Elahe Bayramzadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3334 8421
Email address
elahe.bairamzadeh@iau.ir
Recruitment status
Not yet recruiting
Funding source
Expected recruitment start date
2026-11-11, 1405/08/20
Expected recruitment end date
2026-11-21, 1405/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Investigating the Effect of a Cognitive-Behavioral Intervention on Cognitive Components in Female University Students with Future Anxiety
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
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
Exclusion criteria:
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
Age
From 18 years old to 30 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
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.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Islamic Azad University, Ahvaz
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2026-10-13, 1405/07/21
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.572

Health conditions studied

1

Description of health condition studied
Anxiety disorders related to the future
ICD-10 code
F41.1
ICD-10 code description
Generalized anxiety disorder

Primary outcomes

1

Description
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.

2

Description
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.

3

Description
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.

Secondary outcomes

empty

Intervention groups

1

Description
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.
Category
Treatment - Other

2

Description
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.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Amin Counseling Center, Islamic Azad University of Ahvaz
Full name of responsible person
Elaheh Bayramzadeh
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 902 699 3731
Email
elahe.bairamzadeh@iau.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Aslan Egdarnezhad
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
a_eigder@ymail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
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
Islamic Azad University
Full name of responsible person
Elaheh Bayramzadeh
Position
Master’s Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
elahe.bairamzadeh@iau.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elaheh Bayramzadeh
Position
Master’s Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
elahe.bairamzadeh@iau.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Elaheh Bayramzadeh
Position
Master’s Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
elahe.bairamzadeh@iau.ir

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
Not applicable
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
Analytic Code
Not applicable
Data Dictionary
Not applicable
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