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Trial registered on ANZCTR


Registration number
ACTRN12625000150448
Ethics application status
Approved
Date submitted
5/11/2024
Date registered
7/02/2025
Date last updated
7/02/2025
Date data sharing statement initially provided
7/02/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effectiveness of Cognitive Behavioral Therapy (CBT) in the Treatment of Social Anxiety Disorder
Scientific title
Efficacy of Group Cognitive Behavioural Therapy for the Treatment of Social Anxiety Disorder and Co-morbid Symptoms
Secondary ID [1] 313312 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
social anxiety 335661 0
Patient Health 335662 0
Condition category
Condition code
Mental Health 332224 332224 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A quasi-experimental pre-test post-test control group design will be used in the study. In the first phase of the study, using convenience sampling, screening for recruitment of participants based on greater than cut-off scores on the Social Phobia Inventory (SPIN) and informal diagnostic interviews (based on DSM-5 T-R) for social anxiety disorder (SAD) will be conducted, and only those participants will be recruited who met the inclusion and exclusion criteria of the study. The Social Phobia Inventory is a tool for measuring social anxiety. In the next phase, those who met the eligibility criteria for the study would then be randomly assigned to an experimental and a waitlist control group through the lottery method. The students selected in the experimental group will receive cognitive behavioral group therapy while the other group will be on a waiting list. Cognitive behavioral group therapy follows the treatment manual by Hofmann and Otto in 2018. Each group consists of 20 participants and group CBT will be provided as a 1 / 1.5 hr. weekly session in the University of Haripur counseling center. The total number of sessions will be 12. Group session activities include discussing the treatment model, exposure exercises, brief speeches, and in-vivo exposure tasks. The researcher delivers the intervention under the supervision of a licensed clinical therapist.
Intervention code [1] 329886 0
Prevention
Intervention code [2] 329887 0
Behaviour
Intervention code [3] 329888 0
Rehabilitation
Comparator / control treatment
The waiting list control group will receive no treatment. However, it will be used to compare the pre-post test scores after the intervention.
Control group
Active

Outcomes
Primary outcome [1] 339799 0
Social Anxiety
Timepoint [1] 339799 0
baseline (start of intervention) and at the end of treatment (week 12)
Secondary outcome [1] 441398 0
Patients' Health
Timepoint [1] 441398 0
Baseline (start of intervention) and end of treatment (week 12)

Eligibility
Key inclusion criteria
• Male & female
• Undergraduate student
• Unmarried
• Greater than cut-off on the Social Phobia Inventory (19)
• Given informed consent
Minimum age
15 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Transgender/Otherwise
• Post-Graduate student
• Married/Divorced
• Any Physical Disability
• Severe Cognitive Impairment
• Presence of Psychotic symptoms
• If taking treatment for any psychiatric disorder other than Social Anxiety
• Substance dependence/Abuse
• Non–communicable Diseases

Study design
Purpose of the study
Educational / counselling / training
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
A quasi-experimental pre-test post-test control group design
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
15/10/2024
Date of last participant enrolment
Anticipated
20/02/2025
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
102
Accrual to date
50
Final
Recruitment outside Australia
Country [1] 26676 0
Pakistan
State/province [1] 26676 0
Khyber Pakhtunkhwa (KPK)

Funding & Sponsors
Funding source category [1] 317758 0
Self funded/Unfunded
Name [1] 317758 0
Country [1] 317758 0
Primary sponsor type
Individual
Name
Ayla Khan-The University of Haripur
Address
Country
Pakistan
Secondary sponsor category [1] 320454 0
None
Name [1] 320454 0
Address [1] 320454 0
Country [1] 320454 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316449 0
Research Ethics/Bioethics committee of The University of Haripur
Ethics committee address [1] 316449 0
Ethics committee country [1] 316449 0
Pakistan
Date submitted for ethics approval [1] 316449 0
Approval date [1] 316449 0
04/07/2024
Ethics approval number [1] 316449 0
UOH/DASR/2024/2234

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 137926 0
Ms Ayla Khan
Address 137926 0
The University of Haripur, Hattar Road Near Swat Chowk, Haripur, Khyber Pakhtunkhwa Pakistan
Country 137926 0
Pakistan
Phone 137926 0
+923105726018
Fax 137926 0
Email 137926 0
f21-0297@student.uoh.edu.pk
Contact person for public queries
Name 137927 0
Ayla Khan
Address 137927 0
The University of Haripur, Hattar Road Near Swat Chowk, Haripur, Khyber Pakhtunkhwa Pakistan
Country 137927 0
Pakistan
Phone 137927 0
+923105726018
Fax 137927 0
Email 137927 0
f21-0297@student.uoh.edu.pk
Contact person for scientific queries
Name 137928 0
Ayla Khan
Address 137928 0
The University of Haripur, Hattar Road Near Swat Chowk, Haripur, Khyber Pakhtunkhwa Pakistan
Country 137928 0
Pakistan
Phone 137928 0
+923105726018
Fax 137928 0
Email 137928 0
f21-0297@student.uoh.edu.pk

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.