Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000894392
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
22/02/2026
Date registered
Help: Date registered
20/07/2026
Date last updated
Help: Date last updated
20/07/2026
Date data sharing statement initially provided
Help: Data sharing statement date
20/07/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Brief Cognitive Behavioral Therapy compared with Pharmacotherapy for treating depression and improving well-being in young adults in Pakistan
Scientific title
A quasi-experimental controlled study comparing the effectiveness of Brief Cognitive Behavioral Therapy (individual and group modules) versus pharmacotherapy in reducing depressive symptoms, anxiety, stress, and improving psychological well-being among young adults (18–30 years) in Pakistan
Additional trial identifiers [1] 316603 0
Nil known
Universal Trial Number (UTN)
Trial acronym
BCBT-DEP Study
Related trial records

Health condition
Health condition(s) studied:
Depression 340787 0
Anxiety 340788 0
Stress 340789 0
Condition category
Condition code
Mental Health 336962 336962 0 0
Depression
Mental Health 336963 336963 0 0
Anxiety
Mental Health 337753 337753 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Intervention Arms:
Arm 1: Brief Cognitive Behavioral Therapy – Individual Module
• Manual-based Brief CBT (Cully et al., 2020)
• 4–8 weekly sessions (60 minutes each)
• Face-to-face delivery
• Includes psychoeducation, behavioral activation, cognitive restructuring, homework, relapse prevention
• Delivered by trained clinical psychologist
Arm 2: Brief Cognitive Behavioral Therapy – Group Module
• 4–8 weekly sessions (60 minutes)
• 20–22 participants per group
• Same therapeutic components as individual module
• This study involves a Brief Cognitive Behavioral Therapy (CBT) intervention delivered in two formats: individual and group modules. The intervention is manual based (Cully et al., 2020) and includes core components such as psychoeducation, behavioral activation, cognitive restructuring, and relapse prevention strategies.
• The individual module consists of 4–8 weekly face-to-face sessions (60 minutes each) delivered by a trained clinical psychologist. The group module consists of 4–8 weekly sessions (60 minutes each) with approximately 20–22 participants per group, incorporating the same therapeutic components as the individual format.
• The intervention will be delivered at a well-established university-based counselling centre with appropriate clinical facilities.
• Intervention fidelity and adherence will be monitored using session attendance records, therapist-completed session checklists, and participant homework compliance logs.
• Participants will be allocated using a matched allocation procedure based on baseline depression severity scores measured using the Beck Depression Inventory (BDI). Participants with comparable severity levels will be assigned to study arms to ensure baseline equivalence. Allocation will be conducted sequentially following baseline assessment.
Intervention code [1] 333278 0
Treatment: Other
Intervention code [2] 333279 0
Treatment: Drugs
Description of the comparator or control
Active Comparator: Pharmacotherapy
• Participants in this arm will receive standard antidepressant medication prescribed and monitored by a qualified psychiatrist. Medications may include selective serotonin reuptake inhibitors (SSRIs) such as fluoxetine, sertraline, escitalopram, or paroxetine, as clinically indicated.
• Treatment will be administered in accordance with established clinical guidelines for moderate depression, including the National Institute for Health and Care Excellence (NICE) guidelines and/or locally approved hospital or institutional treatment protocols.
• Medication will be administered orally, with typical starting doses (e.g., fluoxetine 20 mg/day or equivalent), and adjusted based on clinical response. The minimum treatment duration will be eight weeks.
• Adherence and clinical progress will be monitored through regular follow-up consultations, participant self-report, and pill counts.
Control Group: No-Treatment (Assessment-Only Control)
Participants allocated to this group will not receive any psychological or pharmacological intervention during the active study period. They will complete baseline (pre-test), post-intervention, and follow-up assessments at the same timepoints as the intervention groups. This arm serves as an assessment-only control to evaluate the effectiveness of the active interventions.
For ethical considerations, participants in this group will be offered the Individual Brief Cognitive Behavioral Therapy (BCBT) program after completion of the final follow-up assessment.
Control group
Active

Outcomes
Primary outcome [1] 344483 0
Severity of depressive symptoms
Timepoint [1] 344483 0
• Baseline (Week 0) • Post-intervention (Week 8 – Primary Timepoint) • 4 months follow-up
Secondary outcome [1] 458015 0
Depression severity
Timepoint [1] 458015 0
Assessed at baseline, post-intervention (week 8), and 4 months follow-up.
Secondary outcome [2] 460960 0
Anxiety
Timepoint [2] 460960 0
Assessed at baseline, post-intervention (week 8), and 4 months follow-up.
Secondary outcome [3] 460961 0
Stress
Timepoint [3] 460961 0
Assessed at baseline, post-intervention (week 8), and 4 months follow-up.
Secondary outcome [4] 460962 0
Wellbeing
Timepoint [4] 460962 0
Assessed at baseline, post-intervention (week 8), and 4 months follow-up.

Eligibility
Key inclusion criteria
• Age 18–30 years
• Moderate depression level
• University students (Hazara Division)
• Provided informed consent
Minimum age
18 Years
Maximum age
30 Years
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Severe depression requiring inpatient care
• Active suicidal intent
• Psychotic disorders
• Substance dependence
• Severe medical illness

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised 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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
• Descriptive statistics
• Independent t-test
• MANCOVA
• Repeated measures analysis
• SPSS Version 26
• Significance level p < .05

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
1/05/2025
Date of last participant enrolment
Anticipated
Actual
20/08/2025
Date of last data collection
Anticipated
Actual
4/02/2026
Sample size
Target
120
Accrual to date
Final
88
Recruitment outside Australia
Country [1] 27850 0
Pakistan
State/province [1] 27850 0
Khyber Pakhtunkhwa

Funding & Sponsors
Funding source category [1] 321221 0
University
Name [1] 321221 0
The University of Haripur
Country [1] 321221 0
Pakistan
Primary sponsor type
University
Name
University of Haripur
Address
Country
Pakistan
Secondary sponsor category [1] 323929 0
None
Name [1] 323929 0
Address [1] 323929 0
Country [1] 323929 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 319749 0
Ethics Review Committee, The University of Haripur
Ethics committee address [1] 319749 0
Ethics committee country [1] 319749 0
Pakistan
Date submitted for ethics approval [1] 319749 0
18/07/2024
Approval date [1] 319749 0
29/07/2024
Ethics approval number [1] 319749 0

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

Contacts
Principal investigator
Name 148278 0
Ms Saira Bano
Address 148278 0
Department of Psychology, The University of Haripur, Swat Chock, Haripur, KPK Post code 22620
Country 148278 0
Pakistan
Phone 148278 0
+923361576459
Fax 148278 0
Email 148278 0
[email protected]
Contact person for public queries
Name 148279 0
Saira Bano
Address 148279 0
Department of Psychology, The University of Haripur, Swat Chock, Haripur, KPK Post code 22620
Country 148279 0
Pakistan
Phone 148279 0
+923361576459
Fax 148279 0
Email 148279 0
[email protected]
Contact person for scientific queries
Name 148280 0
Saira Bano
Address 148280 0
Department of Psychology, The University of Haripur, Swat Chock, Haripur, KPK Post code 22620
Country 148280 0
Pakistan
Phone 148280 0
+923361576459
Fax 148280 0
Email 148280 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Anyone
Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies exploring new research questions
• Teaching research methods or developing new statistical techniques
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
Not yet decided
Where can requests to access individual participant data be made, or data be obtained directly?
• Email of trial custodian, sponsor or committee: [email protected]

• Postal address: Department of Psychology, The University of Haripur, Swat Chock, Haripur, KPK Post code 22620

Are there extra considerations when requesting access to individual participant data?
No


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.