ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12625000928415p

Ethics application status

Submitted, not yet approved

Date submitted

14/06/2025

Date registered

26/08/2025

Date last updated

26/08/2025

Date data sharing statement initially provided

26/08/2025

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 2

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 2

Secondary ID [1]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Obesity

Polycystic Ovarian Syndrome

Condition category

Condition code

Diet and Nutrition

Obesity

Mental Health

Other mental health disorders

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

This interventional study will be the second phase of the study (this application). It will be an RCT (intervention and control) to test the efficacy of the CBT (Cognitive Behavioral Therapy)-PCOS (Polycystic Ovarian Syndrome) module. The samples would be taken from the O&G clinic from Hospital Sultan Abdul Aziz Shah (HSAAS), Malaysia. The sample size required is 88 (44 each group) and will take five months (two months intervention, one month follow-up and three months follow-up). The participants will meet for 1.5 hour session per week for 8 weeks. A token of appreciation would be given to the participants after completion of the full study in order to encourage adherence to the study.

This module will involve elements of cognitive and behavioral aspects such as managing negative automatic thoughts, dietary changes, lifestyle changes, physical activity, sleep management, etc. For both phases of the study, it will be delivered by a senior clinical psychologist with over 20 years of experience.

Planned Intervention
CBT-PCOS
The module will have a total of 8 sessions. The components of these sessions were abstracted and adapted from past CBT modules. The major areas covered by the module are:
Session 1 – Introduction To the Programme
Session 2 – Dietary Changes
Session 3 – Lifestyle Modification and Movement
Session 4 – Negative Automatic Thoughts
Session 5 – Challenging Negative Automatic Thoughts
Session 6 – Coping Skills for Triggering Situations
Session 7 – Relationship And Intimacy
Session 8 – Relapse Prevention

This programme would mainly focus on medical and behavioural aspects of weight management. The TAU group would be mainly be seen by medical professionals and nutritionists from the O&G clinic. Throughout the intervention period, weekly reminders and words of encouragers will not be sent to the participants. Instead, they will only be reached out to fill in the questionnaire.

Intervention code [1]

Behaviour

Comparator / control treatment

Participants and Recruitment
Participants who meet the inclusion criteria will be contacted and invited to join the intervention through the same O&G clinic in HSAAS. A lottery method will be used to randomly assign participants into intervention and control groups.

Control
Participants in the control group will not be receiving any additional/intervening intervention. They will instead proceed with treatment as usual (TAU) provided by the O&G clinic in HSAAS. The TAU would involve medications for weight reduction, ovulation, insulin resistance (Metformin), fertility supplementation, as well as consultation sessions with a nutritionist. This would be demonstrating the current method of treatment for women with PCOS and obesity based on the international CPG for managing PCOS.

Assessment Points
Participants in both groups will be assessed at baseline (week 0 or pretreatment assessment), 1 month, 3 months, and 6 months after the intervention.

Control group

Active

Outcomes

Primary outcome [1]

To determine if the intervention group in CBT-PCOS improves (measured on the basis of weight loss =5%, BMI) compared to the control group during post-test and follow-up (1-month and 3-months).

Timepoint [1]

Participants will be assessed at five time-points: pre-intervention (0 weeks), mid-intervention (4 weeks), post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up.

Secondary outcome [1]

Change in severity level of negative automatic thoughts.

Timepoint [1]

Baseline; pre-intervention (0 weeks), post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up.

Secondary outcome [2]

Change in frequency of eating behaviour practices.

Timepoint [2]

Baseline; pre-intervention (0 weeks), post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up.

Secondary outcome [3]

Change in level of quality of life.

Timepoint [3]

Baseline; pre-intervention (0 weeks), post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up.

Secondary outcome [4]

Change in severity level of depression and anxiety symptoms.

Timepoint [4]

Baseline; pre-intervention (0 weeks), post-intervention (8 weeks), 1-month follow-up, and 3-month follow-up.

Eligibility

Key inclusion criteria

• Diagnosed with PCOS (according to the Rotterdam 2003 consensus criteria)
• Has a BMI > 23 kg/m2 (according to the MoH CPG guidelines for obesity)
• Are between 18 and 45 years old
• Wishes to become pregnant (measured in demographic section of the questionnaire)
• Consented to participate in the study
• Women with an adequate literacy of the Malay language

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Key exclusion criteria

• Has participated in past psychological interventions for weight management
• Diagnosed severe mental illness (e.g., psychosis)
• Obesity with another endocrine cause (e.g., Prader–Willi syndrome, hyperthyroidism)
• Ovarian tumours that lead to androgen excess adrenal diseases
• Other malformations of the internal genitalia

Study design

Purpose of the study

Treatment

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

A simple lottery method would be conducted to randomise the volunteered participants into one of the two groups – intervention TAU. Equal number of pieces of paper with “1” representing intervention group or “2” representing control group, written on them would be placed into a bowl. The enumerator, not part of this study, would randomly pick out a piece of paper assigning the stated group to the participant on a name list. To minimise potential bias, the name list would be written in numerical, thus minimising the potential for the enumerator to know who the participant is based on their name, ethnicity, age, initial weight, etcetera.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

1/01/2026

Actual

Date of last participant enrolment

Anticipated

1/02/2026

Actual

Date of last data collection

Anticipated

31/07/2026

Actual

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

Malaysia

State/province [1]

Funding & Sponsors

Funding source category [1]

Self funded/Unfunded

Name [1]

Arman Imran Ashok (Self-funded PhD student in Universiti Putra Malaysia)

Address [1]

Country [1]

Malaysia

Primary sponsor type

Individual

Name

Arman Imran Ashok (Self-funded PhD student in Universiti Putra Malaysia)

Address

Country

Malaysia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Submitted, not yet approved

Ethics committee name [1]

Ethics Committee for Research Involving Human Subjects (JKEUPM)

Ethics committee address [1]

jkeupm@upm.edu.my

Ethics committee country [1]

Malaysia

Date submitted for ethics approval [1]

30/04/2025

Approval date [1]

Ethics approval number [1]

Summary

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 the CBT intervention and control group to measure the efficacy of CBT in weight loss.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Arman Imran Ashok

Address

Universiti Putra Malayisa, Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia

Country

Malaysia

Phone

+60137793015

Fax

[email protected]

Contact person for public queries

Name

Arman Imran Ashok

Address

Universiti Putra Malayisa, Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia

Country

Malaysia

Phone

+60137793015

Fax

[email protected]

Contact person for scientific queries

Name

Arman Imran Ashok

Address

Universiti Putra Malayisa, Faculty of Medicine and Health Sciences, UPM, 43400 Serdang, Selangor, Malaysia

Country

Malaysia

Phone

+60137793015

Fax

[email protected]

Data sharing statement

Will the study consider sharing individual participant data?

What supporting documents are/will be available?

Type	Citation	Link	Email	Other Details	Attachment
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.

Trial Review

Documents added manually

Documents added automatically