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IRCT20260726070373N1 IRCT 2026-08-02 Islamic Azad University Effectiveness of cognitive behavioral therapy on rumination and panic attacks The effectiveness of cognitive behavioral therapy on rumination and severity of panic attacks in people with panic disorder and comorbid depression. 2026-08-05 anticipated 35 Complete https://irct.ir/trial/92084 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, Randomization description: Following the initial diagnostic screening, a total of 67 patients diagnosed with Panic Disorder who also met the criteria for comorbid Major Depressive Disorder (MDD) were enrolled in the study. Among these, 30 individuals who met the final eligibility criteria were selected for inclusion in the trial. In this study, simple randomization with an individual-level unit of randomization was employed. Given the sample size (n=30) and the lack of necessity to balance the groups with respect to baseline covariates, no stratification based on age, gender, or treatment center was performed. The random allocation sequence for assigning participants to either the intervention or control group was generated using a random number table. To prevent bias in the allocation process, the generated random sequence was placed inside opaque, identical, tamper-proof, and sealed envelopes. These envelopes were prepared and numbered by an individual independent of the assessment and intervention processes. Following the initial evaluations conducted by the clinical psychologist, the envelope corresponding to each participant was opened in order of entry, and each individual was allocated to one of the two groups (intervention or control) based on the number contained within the envelope. N/A People with panic disorder have comorbid depression. Intervention 1: Intervention group: The intervention group received 12 sessions of 90 minutes, one session per week, face-to-face and individually, with the protocol of Leahy and colleagues, cognitive-behavioral therapy training. This protocol has been translated and evaluated in Iran. Intervention 2: Control group: The control group did not receive any intervention and remained on the waitlist. This group completed a pre-test and post-test at the beginning and end of the study, then after the study was completed, the same treatment was administered to them by a psychologist. Yes - There is a plan to make this available What will be shared: Pre-test and post-test data on dependent variables can be shared after de-identifying individuals. When: Since the beginning of the year 1406 AH To whom: University researchers with an official letter from their supervisor Conditions: No further analysis is permitted. Where to obtain: Corresponding author or supervisor How to obtain: A written request with the seal of the faculty's research vice chancellor is sufficient. Comments:
public Gholamali Nikpoor
Islamic Azad University, Ayatollah Amoli Branch, University Sub-road, Km 5 of the Old Amol-Babol Road, Amol, Mazandaran Province, Iran
Amol Iran (Islamic Republic of) 3358461514 +98 11 4321 7061 Nikpoorg@yahoo.com Islamic Azad University scientific Sepideh Rahnama
Islamic Azad University, Ayatollah Amoli Branch, University Sub-road, Km 5 of the Old Amol-Babol Road, Amol, Mazandaran Province, Iran
Amol Iran (Islamic Republic of) 3358461514 +98 11 4321 7061 Sepideh.rahnama79@gmail.com Islamic Azad University Iran (Islamic Republic of) 1. Definitive diagnosis of Panic Disorder by a qualified clinical psychologist, during a clinical interview (recorded in patients' files at the initial session) based on the DSM-5-TR diagnostic criteria 2. Definitive diagnosis of Major Depressive Disorder by a qualified clinical psychologist, during a clinical interview (recorded in patients' files at the initial session) based on the DSM-5-TR diagnostic criteria 3. Being a resident and a client of psychological centers in the eastern and central regions of Mazandaran province 4. Providing written informed consent to participate in the study 5. Not receiving concurrent treatment (psychiatric and psychotherapeutic) 17 years no limit Both Having severe psychological disorders (such as schizophrenia) that may interfere with the cognitive-behavioral therapy process Diagnosis of a mental disorder other than panic disorder and major depression F41.0 Panic disorder [episodic paroxysmal anxiety] without agoraphobia Behavior N/A Intervention group: The intervention group received 12 sessions of 90 minutes, one session per week, face-to-face and individually, with the protocol of Leahy and colleagues, cognitive-behavioral therapy training. This protocol has been translated and evaluated in Iran. Control group: The control group did not receive any intervention and remained on the waitlist. This group completed a pre-test and post-test at the beginning and end of the study, then after the study was completed, the same treatment was administered to them by a psychologist. Severity of panic attacks. Timepoint: Pre-test and post-test. Method of measurement: (Albany Panic and Phobia Questionnaire (APPQ)). Rumination. Timepoint: Pre-test and post-test. Method of measurement: (Ruminative Response Scale (RRS)). Islamic Azad University Approved 2024-06-10 Research Ethics Committees of Islamic Azad University - Ayatollah Amoli Branch Islamic Azad University, Ayatollah Amoli Branch, University Sub-road, Km 5 of the Old Amol-Babol Road, Amol, Mazandaran Province, Iran Amol Mazandaran Iran (Islamic Republic of)