None listed
Conditions
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.
Interventions
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 participan
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.
Sponsors
Arman Imran Ashok (Self-funded PhD student in Universiti Putra Malaysia)
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
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
Outcome results
None listed