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The effectiveness of group cognitive behavioral therapy on anxiety treatment and social support in patients with panic disorder.

Protocol summary

Study aim
Determining the effectiveness of group cognitive behavioral therapy on anxiety sensitivity and perceived social support in patients with panic disorder
Design
Clinical trial of the effectiveness of the treatment group plus the control group, with a parallel group, does not have blinding. 30 people are selected through purposeful randomization and then they are placed into groups through simple randomization.
Settings and conduct
The study is conducted among people with panic disorder who refer to counseling and psychological services centers in Ahvaz. After screening and meeting the entry requirements, 30 people are selected through purposive sampling and randomly assigned to two experimental and control groups (15 people in each group). Interventions are implemented in 12 60-minute sessions, one session per week, for two months. The control group will not receive any intervention until the end of the study, and blinding will not be performed in this study.
Participants/Inclusion and exclusion criteria
Inclusion criteria included: diagnosis of generalized anxiety disorder based on DSM-5-TR criteria, having a minimum level of literacy to understand treatment materials and respond to research instruments, informed consent to participate in the study, and exclusion criteria included: having severe psychiatric disorders, cognitive disability, or mental retardation that prevents effective participation in sessions, and receiving other concurrent psychotherapy.
Intervention groups
The intervention group includes patients with panic disorder who will undergo a therapeutic intervention protocol during 12 60-minute sessions, one session per week, while the control group will not receive any intervention.
Main outcome variables
Anxiety sensitivity, perceived social support

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260801070482N1
Registration date: 2026-08-29, 1405/06/07
Registration timing: registered_while_recruiting

Last update: 2026-08-29, 1405/06/07
Update count: 0
Registration date
2026-08-29, 1405/06/07
Registrant information
Name
Masomeh Kamaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 61 3347 8525
Email address
farnazsg1393@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-08-15, 1405/05/24
Expected recruitment end date
2026-10-16, 1405/07/24
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of group cognitive behavioral therapy on anxiety treatment and social support in patients with panic disorder.
Public title
Investigating the effectiveness of group cognitive behavioral therapy on anxiety sensitivity and perceived social support
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Diagnosis of panic disorder based on DSM-5-TR criteria by a psychiatrist or clinical psychologist Have a minimum level of reading and writing literacy to understand treatment materials and respond to research tools Willingness to participate in the research and signing the informed consent form
Exclusion criteria:
Starting another psychological treatment at the same time Having severe psychiatric disorders Cognitive disability or mental retardation that prevents effective participation in meetings
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Random assignment of eligible individuals to the intervention and control groups will be simple random, using a random sequence generated by a random number table on the Randomization.com website. (To prepare a randomization list on the Randomization.com website, first enter the number of samples, the number of groups, and the type of randomization (such as block); then the website automatically generates a random list for assigning individuals to the research groups, which can be used in the sampling or subject allocation process.) This sequence is written in lowercase letters and kept in a sealed envelope. When each individual is selected, the envelope is opened and the individual is assigned to the counseling or control group according to the code.
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 Branch
Street address
Southern Kargar Boulevard, Culture City, Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Approval date
2026-07-21, 1405/04/30
Ethics committee reference number
IR.IAU.AHVAZ.REC.1405.446

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 sensitivity
Timepoint
At the start of the intervention, 2 weeks after the intervention, 8 weeks after the intervention, 2 months after the end of the intervention
Method of measurement
Anxiety Sensitivity Scale (ASI) (2005)

2

Description
Perceived social support
Timepoint
At the start of the intervention, 2 weeks after the intervention, 8 weeks after the intervention, 2 months after the end of the intervention
Method of measurement
Zimet et al.'s Perceived Social Support Questionnaire (1988)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Session 1: The first session focused on establishing a therapeutic alliance by introducing the therapist and group members and explaining the fundamental group rules, including confidentiality, mutual respect, and active participation. The overall structure of the treatment program was then outlined, followed by an introduction to panic disorder, its clinical features, and common symptoms. The cognitive-behavioral model of panic disorder was presented, emphasizing the panic cycle consisting of bodily sensations, catastrophic misinterpretations, increased anxiety, intensification of physical symptoms, and the occurrence of panic attacks. In addition, the concept of anxiety sensitivity and its role in maintaining panic attacks were explained. At the end of the session, participants were asked to draw their own personal panic cycle and were assigned homework to monitor and record panic attacks, associated thoughts, emotions, and behaviors throughout the week.Session 2: The second session began with a review of the previous week's homework. Participants were then introduced to the concept of automatic thoughts and the cognitive distortions commonly associated with panic disorder. The concept of anxiety sensitivity and its relationship with catastrophic interpretations of bodily sensations was further explored, enabling participants to recognize automatic thoughts that occur during episodes of anxiety. Practical exercises focused on identifying and recording automatic thoughts, and participants were assigned homework to complete thought-record forms whenever they encountered anxiety-provoking situations during the week.Session 3: The third session was devoted to cognitive restructuring. Participants were taught how to evaluate evidence supporting and contradicting dysfunctional thoughts and were encouraged to examine irrational beliefs and catastrophic interpretations related to bodily sensations and panic attacks. Subsequently, techniques for replacing maladaptive thoughts with more rational and realistic alternatives were introduced. Participants practiced cognitive restructuring using an actual panic attack they had experienced. Daily cognitive restructuring exercises were assigned as homework to reinforce the newly acquired skills.Session 4: The primary objective of the fourth session was to reduce physiological arousal and enhance participants' sense of control over anxiety symptoms. Diaphragmatic breathing and progressive muscle relaxation techniques were introduced and practiced. The role of breathing patterns in maintaining or alleviating the panic cycle was also discussed. Participants engaged in guided breathing and relaxation exercises during the session and were instructed to practice these techniques daily at home.Session 5: The fifth session focused on interoceptive exposure as a key cognitive-behavioral intervention for panic disorder, with the aim of reducing fear of anxiety-related bodily sensations. Participants were introduced to the rationale for interoceptive exposure and completed exercises such as rapid breathing, spinning in a chair, and running in place to deliberately induce physical sensations similar to those experienced during panic attacks. Subjective anxiety levels were monitored using the Subjective Units of Distress Scale (SUDS). Participants were instructed to continue these interoceptive exposure exercises at home while recording their anxiety levels.Session 6: During the sixth session, participants identified their individual safety behaviors commonly used to prevent or reduce anxiety and examined how these behaviors contributed to the maintenance of panic disorder. Strategies for the gradual elimination of safety behaviors were introduced, and each participant selected one specific safety behavior to discontinue. As homework, participants were asked to document their experiences of eliminating the selected safety behavior and to report any resulting changes.Session 7: The seventh session focused on situational exposure. Participants first developed individualized fear hierarchies consisting of anxiety-provoking and avoided situations. The principles of gradual exposure were then explained, followed by the implementation of an initial exposure exercise within the therapeutic setting using a relatively low-anxiety situation. This exercise allowed participants to gain confidence through successful exposure experiences. Participants were subsequently instructed to continue gradual exposure in real-life situations as their weekly homework.Session 8: The eighth session aimed to improve participants' coping abilities by teaching a structured problem-solving approach. Participants learned the sequential steps of problem-solving, including problem identification, generation of alternative solutions, evaluation of possible outcomes, selection of the most appropriate solution, and implementation of the chosen strategy. Real-life problems presented by participants were addressed using this framework, and they were assigned homework to apply the problem-solving process to an actual stressful situation encountered during the following week.Session 9: The ninth session emphasized the importance of social support in managing anxiety. The therapeutic role of family members, friends, and supportive social networks was discussed, followed by training in effective interpersonal skills, including assertiveness, appropriate help-seeking, and active listening. Participants practiced requesting support through role-playing exercises and were instructed to apply these communication skills with at least one family member or friend during the week while documenting their experiences.Session 10: The tenth session focused on strengthening social relationships and reducing behavioral isolation. Participants identified barriers that limited their social interactions and discussed the beneficial effects of supportive relationships on anxiety reduction. Individualized plans for increasing social engagement were then developed, and participants created weekly activity schedules designed to enhance social participation. Homework consisted of completing at least two planned social activities and recording their experiences and emotional responses.Session 11: The eleventh session was designed to consolidate and integrate the cognitive and behavioral skills acquired throughout the treatment program. Cognitive restructuring, interoceptive and situational exposure techniques, and interpersonal communication skills were comprehensively reviewed, and participants' therapeutic progress was evaluated. Participants then analyzed a real-life anxiety-provoking situation by simultaneously applying all previously learned cognitive and behavioral strategies. They were encouraged to continue integrating these skills into everyday anxiety-provoking situations as part of their homework.Session 12: The final session focused on reviewing the major therapeutic concepts and evaluating the progress achieved throughout the intervention. Potential risk factors for relapse were identified, and each participant developed a personalized relapse prevention plan. Emphasis was placed on the continued practice of cognitive and behavioral techniques, gradual exposure exercises, effective communication skills, maintenance of supportive interpersonal relationships, and ongoing self-monitoring of anxiety symptoms. Finally, participants designed individualized anxiety management plans intended to help maintain therapeutic gains and reduce the likelihood of relapse following completion of the treatment program.
Category
Treatment - Other

2

Description
Control group: They do not receive any intervention.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Ideh Clinic
Full name of responsible person
Mohammad Izadi
Street address
Unit 5, No. 182, Zeytoun Street, Zeytoun Karmandi
City
Ahvaz
Province
Khouzestan
Postal code
61752363398
Phone
+98 61 3335 2652
Email
ideh_clinic777@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mehdi Shamsipour
Street address
South Kargar Blvd, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Email
info@iauahvaz.ac.ir
Web page address
https://ahvaz.iau.ir/fa
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
Masomeh Kamaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
South Kargar Blvd, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Fax
Email
info@iauahvaz.ac.ir
Web page address
https://ahvaz.iau.ir/fa

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masomeh Kamaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
South Kargar Blvd, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Fax
Email
info@iauahvaz.ac.ir
Web page address
https://ahvaz.iau.ir/fa

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Masomeh Kamaei
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
South Kargar Blvd, Farhang Shahr
City
Ahvaz
Province
Khouzestan
Postal code
6134937333
Phone
+98 61 3334 8421
Fax
Email
info@iauahvaz.ac.ir
Web page address
https://ahvaz.iau.ir/fa

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study data, treatment protocol
When the data will become available and for how long
After publishing the articles
To whom data/document is available
All those interested in research in this field
Under which criteria data/document could be used
Any type of analysis on the submitted data is permitted and acceptable with attribution of the source
From where data/document is obtainable
Via Masomeh Kamaei at: m_kamaeiii@gmail.com
What processes are involved for a request to access data/document
Send an email to Masomeh Kamaei and after approval by the research team members, the data will be sent.
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