Protocol summary

Study aim
Determining the Effectiveness of Cognitive-Behavioral Therapy-Based Group Therapy on Distress Tolerance and Social Anxiety in Students of Islamic Azad University, Shiraz Branch
Design
Controlled clinical trial with two parallel groups, randomized using simple randomization, including 50 students, with 25 participants in the experimental group and 25 participants in the control group. The trial phase is not applicable. A table of random numbers will be used for randomization.
Settings and conduct
The study will determine the effectiveness of cognitive-behavioral therapy-based group therapy on distress tolerance and social anxiety in students of Islamic Azad University, Shiraz Branch. After obtaining informed consent, 50 participants will be randomly assigned to the experimental and control groups using a table of random numbers. Pretest and posttest assessments will be conducted using the Distress Tolerance Scale (DTS) and the Social Phobia Inventory (SPIN). The experimental group will receive 10 weekly group therapy sessions, 90 minutes per session, and the control group will not receive the intervention. The sessions will be held at a suitable location in accordance with the principles of group therapy.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Being a student at Islamic Azad University, Shiraz Branch, having social anxiety, informed consent to participate in the study; Exclusion Criteria: Severe psychiatric disorder affecting participation, receiving similar psychotherapy, inability to attend the sessions regularly
Intervention groups
Experimental Group: 10 weekly sessions of cognitive-behavioral therapy-based group therapy, 90 minutes per session Control Group: No intervention during the study
Main outcome variables
Distress Tolerance; Social Anxiety

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20260816070674N1
Registration date: 2026-08-21, 1405/05/30
Registration timing: prospective

Last update: 2026-08-21, 1405/05/30
Update count: 0
Registration date
2026-08-21, 1405/05/30
Registrant information
Name
Marzieh Zare Mohazabieh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3721 0726
Email address
marziezare75@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2026-09-06, 1405/06/15
Expected recruitment end date
2026-10-07, 1405/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effectiveness of Cognitive-Behavioral Therapy (CBT)-Based Group Therapy on Distress Tolerance and Social Anxiety in Students
Public title
Effectiveness of Cognitive-Behavioral Therapy-Based Group Therapy on Distress Tolerance and Social Anxiety
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Being a student and being enrolled at Islamic Azad University, Shiraz Branch Obtaining a score indicative of social anxiety on the screening scale Willingness and informed consent to participate in the study
Exclusion criteria:
Having a severe psychiatric disorder that prevents effective participation in the sessions Receiving similar psychotherapy concurrently at the time of enrollment in the study Inability to attend the group therapy sessions regularly
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
Randomization (investigator's opinion)
Randomized
Randomization description
The eligible participants will be assigned to the experimental and control groups using simple randomization with the individual participant as the unit of randomization. After identifying eligible participants and obtaining informed consent, the allocation sequence of the participants to the experimental and control groups will be determined using a table of random numbers. The group assignment of each participant will be determined after the randomization process is completed.
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 for Research of Islamic Azad University, Marvdasht Branch
Street address
3rd Kilometer, Takht-e Jamshid Blvd., Marvdasht
City
Marvdasht
Province
Fars
Postal code
73711-13119
Approval date
2026-08-11, 1405/05/20
Ethics committee reference number
IR.IAU.M.REC.1405.394

Health conditions studied

1

Description of health condition studied
Social Anxiety
ICD-10 code
F40.1
ICD-10 code description
Social phobias

2

Description of health condition studied
Distress Tolerance
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Social anxiety score on the Social Phobia Inventory (SPIN)
Timepoint
Measurement at pretest, before the intervention, and at posttest, after completion of 10 group therapy sessions.
Method of measurement
Social Phobia Inventory

2

Description
Distress tolerance score on the Distress Tolerance Scale (DTS)
Timepoint
Measurement at pretest, before the intervention, and at posttest, after completion of 10 group therapy sessions.
Method of measurement
Distress Tolerance Scale

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: Receiving 10 weekly sessions of cognitive-behavioral therapy-based group therapy, with each session lasting 90 minutes, based on the standard cognitive-behavioral therapy protocol.
Category
Behavior

2

Description
Control group: Not receiving cognitive-behavioral therapy-based group therapy during the study period.
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Islamic Azad University, Shiraz Branch
Full name of responsible person
Marzieh Zare Mohazabieh
Street address
5th Kilometer, Sadra City, Shiraz
City
Shiraz
Province
Fars
Postal code
71987-74731
Phone
+98 71 3641 0059
Email
shiraz.info@iau.ac.ir
Web page address
https://shiraz.iau.ir/fa

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Ruhollah Ershadi
Street address
Valayat Building, Beginning of Shahid Raisali Delvari Boulevard, Shohada Square, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7515895496
Phone
+98 77 3335 0172
Email
info@bushehr.iau.ir
Web page address
https://bushehr.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
Marzieh Zare Mohazabieh
Position
Master's Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 336, 10th Alley, Mardani Sharqi St., Janbazan Blvd.
City
Shiraz
Province
Fars
Postal code
7157677447
Phone
+98 71 3721 0726
Fax
Email
marziezare75@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr. Alireza Bibak
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Psychology
Street address
No. 36, Laleh 15 Alley, Besim, Next to Bolour 1 Apartment, Bushehr
City
Bushehr
Province
Boushehr
Postal code
7516767444
Phone
+98 77 3355 1386
Email
3520152169@iau.ir

Person responsible for updating data

Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Marzieh Zare Mohazabieh
Position
Master's Student in Clinical Psychology
Latest degree
Bachelor
Other areas of specialty/work
Psychology
Street address
No. 336, 10th Alley, Mardani Sharqi St., Janbazan Blvd., Shiraz
City
Shiraz
Province
Fars
Postal code
7157677447
Phone
+98 71 3721 0726
Fax
Email
marziezare75@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
No further information is available.
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
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