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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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12625001019493
Enrollment
203
Registered
2025-09-15
Start date
2025-10-01
Completion date
2025-12-31
Last updated
2025-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is a clinical trial study to test the efficacy of Cognitive Behavioural Therapy (CBT) in weight reduction and improving psychological well-being amongst obese women with PCOS. In this phase of the study it would involve cross-sectional study amongst overweight and obese women with PCOS to determine the prevalence and relationship between multiple variables being measured.

Interventions

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

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.

Sponsors

Arman Imran Ashok - Universiti Putra Malaysua (UPM)
Lead SponsorIndividual

Eligibility

Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No

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

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)

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026