Protocol summary

Study aim
The Effectiveness of Cognitive Behavioral Therapy (CBT) in Reducing Anxiety Symptoms in Female Patients with Panic Disorder Referring to Counseling Centers
Design
A controlled clinical trial with parallel groups, without blinding, randomized, on 30 patients. The rand function of Excel software will be used for randomization.
Settings and conduct
The statistical population includes all girls with panic disorder (aged 18 to 30) who refer to the Rayan Psychological Counseling and Services Center in Ahvaz during Khordad 1405. In the sample selection stage, a convenience sampling method is used. After selecting a sample of 30 participants based on the study’s inclusion and exclusion criteria, the participants will be randomly assigned to two groups: the “Cognitive‑Behavioral Therapy” (intervention group) and the “waiting list” (control group).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Definite diagnosis of panic disorder based on DSM-5-TR criteria by a psychiatrist or psychologist at the center, having a minimum average score (above 16) on the Beck Anxiety Inventory (BAI). Exclusion criteria: Unwillingness to participate in the research, simultaneous participation in other counseling or psychotherapy courses.
Intervention groups
Intervention group: All individuals who will receive the cognitive behavioral therapy intervention. Control group: All individuals who will receive no intervention.
Main outcome variables
Anxiety, Panic Disorder

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260511069364N1
Registration date: 2026-05-14, 1405/02/24
Registration timing: prospective

Last update: 2026-05-14, 1405/02/24
Update count: 0
Registration date
2026-05-14, 1405/02/24
Registrant information
Name
Kowsar Kowsarinezhad
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 4242 1383
Email address
kosar.kosari1378@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-05-31, 1405/03/10
Expected recruitment end date
2026-06-20, 1405/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Cognitive Behavioral Therapy (CBT) in Reducing Anxiety Symptoms in Female Patients with Panic Disorder Referring to Counseling Centers
Public title
Evaluating the effectiveness of cognitive behavioral therapy in reducing anxiety in girls with panic disorder
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Definite diagnosis of panic disorder based on DSM-5-TR criteria by a psychiatrist or psychologist at the center Having a minimum average score (above 16) on the Beck Anxiety Inventory (BAI) Girls between the ages of 18 and 30
Exclusion criteria:
Unwillingness to participate in the research Suffering from severedisorders such as schizophrenia Simultaneous participation in other counseling or psychotherapy courses.
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: 30
Randomization (investigator's opinion)
Randomized
Randomization description
The statistical population consists of all female patients with panic disorder (aged 18 to 30) who refer to the Counseling and Psychological Services Center during June 2026. In this type of effectiveness study, a two‑stage approach is typically used. In the sampling stage, convenience sampling is applied. After selecting a sample of 30 participants based on the study’s inclusion and exclusion criteria, the participants will be randomly assigned to two groups: the “Cognitive‑Behavioral Therapy intervention group and the “waiting list” control group. Randomization will be performed using variable block sizes (4 and 6 participants) by an independent statistician who is not involved in the implementation process. The random allocation list will be generated using the RAND function in Excel and then placed in 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, and group assignment will be revealed only at the time each participant enters the study. To ensure baseline equivalence of variables (such as anxiety level, age), their distribution across the two groups will be examined during statistical analysis.
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 of Ahvaz Branch
Street address
Opposite Keshavarz Street, Farhang Shahr, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2026-04-15, 1405/01/26
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.041

Health conditions studied

1

Description of health condition studied
Panic Disorder
ICD-10 code
F41.0
ICD-10 code description
Panic disorder [episodic paroxysmal anxiety] without agoraphobia

Primary outcomes

1

Description
Anxiety
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 measurement method will be the Beck Anxiety Inventory Epstein et al. (1988).

2

Description
Panic Disorder
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 method of measurement will be the Panic Disorder Severity Scale by Shear et al.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Cognitive Behavioral Therap .Duration of each session: 90 minutes; Total number of sessions: 8 sessions; Session sequence: twice a week.Therapeutic tools used:This intervention focuses on education about panic disorder, identifying and correcting maladaptive beliefs associated with panic symptoms, and most importantly, gradual and controlled exposure to physical symptoms and avoided situations. The main tools include psychoeducation, cognitive restructuring, breathing exercises, relaxation techniques, and exposure protocols (interoceptive and situational).Session content:Session 1: Introduction, administration of the pre-test, and initial education about panic disorder and its cycle.Session 2: Identifying catastrophic thoughts and training in cognitive restructuring.Session 3: Continuation of cognitive restructuring and diaphragmatic breathing training.Session 4: Initiation of interoceptive exposure to physical symptoms.Session 5: Continuation of interoceptive exposure and preparation of a hierarchy of feared situations.Session 6: Initiation of situational exposure to avoided situations.Session 7: Continuation of situational exposure and skill consolidation.Session 8: Conclusion, relapse prevention, post-test, and follow-up.
Category
Treatment - Other

2

Description
Control group: The control group will not receive any intervention during the research, but will receive the intervention after data collection to prevent factors that threaten the internal validity of the research, such as compensatory competition from the control group or demoralization.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Rayan Consulting Center Ahvaz
Full name of responsible person
Kowsar Kowsarinezhad
Street address
1st Floor, Mahtab Complex, between 4th and 5th Eastern Streets, Kianpars
City
Ahvaz
Province
Khouzestan
Postal code
6133921294
Phone
+98 61 3392 1294
Email
rjoharifard@gmail.com

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
Private
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
Kowsar Kowsarinezhad
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 120, Pasdar Street, Azadegan Alley
City
Dezful
Province
Khouzestan
Postal code
6461646917
Phone
+98 61 4242 1383
Email
kosar.kosari1378@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kowsar Kowsarinezhad
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 120, Pasdar Street, Azadegan Alley
City
Dezful
Province
Khouzestan
Postal code
6461646917
Phone
+98 61 4242 1383
Email
kosar.kosari1378@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Kowsar Kowsarinezhad
Position
Master's student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 120, Pasdar Street, Azadegan Alley
City
Dezful
Province
Khouzestan
Postal code
6461646917
Phone
+98 61 4242 1383
Email
kosar.kosari1378@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
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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