Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625001019493p
Ethics application status
Submitted, not yet approved
Date submitted
11/07/2025
Date registered
15/09/2025
Date last updated
15/09/2025
Date data sharing statement initially provided
15/09/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Efficacy of Cognitive Behavioural Therapy In Reducing Weight And Improving Psychological Well-Being Amongst Women With Polycystic Ovary Syndrome In Hospital Sultan Abdul Aziz Shah - Phase 1
Scientific title
Efficacy of Cognitive Behavioural Therapy In Reducing Weight And Improving Psychological Well-Being Amongst Women With Polycystic Ovary Syndrome In Hospital Sultan Abdul Aziz Shah - Phase 1
Secondary ID [1] 314886 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Obesity 338175 0
Polycystic Ovarian Syndrome 338176 0
Condition category
Condition code
Diet and Nutrition 334455 334455 0 0
Obesity
Mental Health 334456 334456 0 0
Other mental health disorders

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
This observational study will be the first part of the study (this application). It will be a cross-sectional design to measure the prevalence and severity levels of multiple variables (BMI, Negative Automatic Thoughts, Anxiety, Depression, Eating Behaviours, and Quality of Life) amongst overweight and obese women diagnosed with PCOS (Polycystic Ovarian Syndrome).

It is emphasised that the participants will read the participant information sheet (5 minutes) followed by the informed consent and click the agreement button (5 minutes). The participants will then proceed to the actual questionnaire part one, which will be on the general sociodemographic questions (5 minutes), followed by ATQ-M (10 minutes), HADS-M (10 minutes), EBPQ-M (15 minutes), and PCOSQ-M (15 minutes). Then participants will click the submit button which will end their participation, followed by a message on screen to contact the principal investigator if they have questions or require assistance.

The samples would be taken from the O&G clinic from Hospital Sultan Abdul Aziz Shah (HSAAS), Malaysia. The sample size required is 203 (accounting for 20% dropout or unusable responses) and will take three months long to collect data. The questionnaire will be distributed via Google Forms to participants at the O&G clinic. Each participant will only require to participate on a once off, from time of enrolment for 3 months. The involvement of the participants are to provide data about their current level of functioning based on the items asked in the questionnaire.
Intervention code [1] 331492 0
Not applicable
Comparator / control treatment
No control group as this is an observational study.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 342158 0
The primary outcome will be the prevalence rates of obesity among women with PCOS.
Timepoint [1] 342158 0
Assessed at 3 months post first participant enrolment.
Primary outcome [2] 342764 0
The primary outcome will be the prevalence rates for clinically significant anxiety and depressive symptoms among women with PCOS.
Timepoint [2] 342764 0
Assessed at 3 months post first participant enrolment.
Secondary outcome [1] 452053 0
The primary outcome will be the level of quality of life among women with PCOS.
Timepoint [1] 452053 0
Assessed at 3 months post first participant enrolment.

Eligibility
Key inclusion criteria
1) Diagnosed with PCOS (according to the Rotterdam 2003 consensus criteria)
2) Are between 18 and 45 years old
3) Women with an adequate literacy of the Malay language
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Do not consent to participate in the study
2) Diagnosed severe mental illness (e.g., psychosis)
3) Obesity with another endocrine cause (e.g., Prader–Willi syndrome, hyperthyroidism)

Study design
Purpose
Natural history
Duration
Cross-sectional
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2025
Actual
Date of last participant enrolment
Anticipated
31/12/2025
Actual
Date of last data collection
Anticipated
31/12/2025
Actual
Sample size
Target
203
Accrual to date
Final
Recruitment outside Australia
Country [1] 27209 0
Malaysia
State/province [1] 27209 0
Selangor

Funding & Sponsors
Funding source category [1] 319441 0
Self funded/Unfunded
Name [1] 319441 0
Arman Imran Ashok
Country [1] 319441 0
Malaysia
Primary sponsor type
Individual
Name
Arman Imran Ashok - Universiti Putra Malaysua (UPM)
Address
Country
Malaysia
Secondary sponsor category [1] 321937 0
None
Name [1] 321937 0
Address [1] 321937 0
Country [1] 321937 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318015 0
Ethics Committee for Research Involving Human Subjects (JKEUPM)
Ethics committee address [1] 318015 0
Ethics committee country [1] 318015 0
Malaysia
Date submitted for ethics approval [1] 318015 0
30/04/2025
Approval date [1] 318015 0
Ethics approval number [1] 318015 0

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

Contacts
Principal investigator
Name 142874 0
Mr Arman Imran Ashok
Address 142874 0
Universiti Putra Malayisa, Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia
Country 142874 0
Malaysia
Phone 142874 0
+60137793015
Fax 142874 0
Email 142874 0
[email protected]
Contact person for public queries
Name 142875 0
Arman Imran Ashok
Address 142875 0
Universiti Putra Malayisa, Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia
Country 142875 0
Malaysia
Phone 142875 0
+60137793015
Fax 142875 0
Email 142875 0
[email protected]
Contact person for scientific queries
Name 142876 0
Arman Imran Ashok
Address 142876 0
Universiti Putra Malayisa, Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia
Country 142876 0
Malaysia
Phone 142876 0
+60137793015
Fax 142876 0
Email 142876 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Informed consent form    JKEUPM_FORM_2.4_-_(ENGLISH_VERSION)_RESPONDENT’S_INFORMATION_SHEET_AND_INFORMED_CONSENT.pdf


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.