Back to History

Fields Changed

Registration

Field Before After
Trial Status on_going completed
Abstract Background: Polycystic Ovarian Syndrome (PCOS) is an endocrine disorder effecting up-to 8-13% of women during their reproductive age. Along with health-related concerns, PCOS impacts the emotional and psychological well-being of individuals, leading to symptoms such as body image concerns, low self-esteem, and psychological distress related to physical symptoms (Azizi & Elyasi, 2017; Dewani et al., 2023). In addressing these challenges, the effectiveness of coping skills emerges as a crucial factor. Effective strategies, such as problem-focused coping, can mitigate stress and enhances quality of life (Morshedi et al., 2021), whereas maladaptive strategies, like escape-avoidance are linked to increased psychological distress, greater interpersonal sensitivity and social difficulties (Ding et al., 2021). Despite incredible advancements in treatment of endocrine disorders, little is known about causes and consequences of PCOS, which limits our understanding of its psychological management. To address this gap, the present study will provide insights into CBT-based intervention for PCOS and examine its effectiveness. Objectives: The study will focus on managing psychological distress and developing effective coping skills (primary outcomes); and improving body image, self-esteem, interpersonal sensitivity and PCOS related quality of life (secondary outcomes). Research Design: Young women diagnosed with PCOS (N= 46) aged 20-39 years will be recruited for the study. The study will be a randomized controlled trial, therefore, the participants will be divided equally into an experimental group (N=23) and a waiting list group (N=23). The study will be divided into three phases; pretest, intervention, and post-test. Participants in both groups will be administered in the pretest and post-test. However, the intervention will be given only to the experimental group. The participants (N=46) will be asked to fill Depression Anxiety Stress Scale-21 (Lovibond & Lovibond, 1995), Brief-Coping Orientation to Problems Experiences Inventory (Carver, 1997), Body Self-Image Questionnaire Short-Form (Rowe, 2005), Rosenberg Self-esteem Scale (Rosenberg, 1997), Interpersonal Sensitivity Measure (Boyce & Parker, 1989) and Polycystic Ovarian Syndrome Quality of Life Scale (Williams et al., 2018) during pretest and post-test. The intervention phase will comprise of 12 sessions which will be divided across 6-weeks,and will be a CBT-based intervention plan. Statistical analysis: IBM-SPSS-26 will be utilized to assess the efficacy of a CBT-based intervention plan for both primary and secondary outcomes. The study will employ t-test to confirm the study hypotheses. Anticipated Results & Significance: The study is expected to show significant improvement in psychological distress and coping skills among women with PCOS after CBT-based intervention, with positive effects on secondary variables. These results will provide empirical evidence supporting role of CBT in managing PCOS, promoting holistic treatment approaches that address both the psychological and physical aspects of PCOS Background: Polycystic Ovarian Syndrome (PCOS) is a prevalent endocrine disorder, affecting approximately 8–13% of women of reproductive age. Beyond its physiological implications, PCOS significantly influences emotional and psychological functioning, often manifesting in concerns related to body image, diminished self-esteem, and psychological distress tied to physical symptoms (Azizi & Elyasi, 2017; Dewani et al., 2023). Coping strategies play a pivotal role in navigating these challenges. Adaptive coping mechanisms, such as problem-focused strategies, have been shown to alleviate stress and enhance overall quality of life (Morshedi et al., 2021). Conversely, maladaptive responses like avoidance or escape strategies are associated with heightened distress, interpersonal difficulties, and increased sensitivity (Ding et al., 2021). Despite advancements in medical treatments for endocrine disorders, limited attention has been given to the psychological implications and management of PCOS. To bridge this gap, the present study aims to explore the impact of a CBT-based intervention in addressing psychological difficulties associated with PCOS. Objectives: The primary aim is to reduce psychological distress and strengthen coping strategies in women with PCOS. Secondary objectives include improvements in body image, self-esteem, interpersonal sensitivity, and PCOS-related quality of life. Research Design: A randomized controlled trial will be conducted involving 46 women aged 20–39 diagnosed with PCOS. Participants will be randomly assigned to either an experimental group (n = 23) or a waitlist control group (n = 23). The study will include three phases: pretest, intervention, and post-test. All participants will complete pre- and post-intervention assessments. However, only the experimental group will receive a 6-week CBT-based intervention, consisting of 12 structured sessions. Assessment tools will include the Depression Anxiety Stress Scale-21 (Lovibond & Lovibond, 1995), Brief COPE (Carver, 1997), Body Self-Image Questionnaire-Short Form (Rowe, 2005), Rosenberg Self-Esteem Scale (Rosenberg, 1997), Interpersonal Sensitivity Measure (Boyce & Parker, 1989), and the PCOS Quality of Life Scale (Williams et al., 2018). Statistical Analysis: Data will be analyzed using IBM SPSS version 26. Paired and independent sample t-tests will be conducted to evaluate the effectiveness of the intervention on both primary and secondary outcomes. Anticipated Results & Significance: The intervention is anticipated to yield significant reductions in psychological distress and improvements in coping abilities. Furthermore, favorable outcomes are expected in terms of body image, self-esteem, interpersonal sensitivity, and overall quality of life. Findings from this study will offer valuable evidence for the integration of CBT into comprehensive treatment plans for women with PCOS, addressing both psychological and physiological dimensions of the condition.
Last Published January 16, 2025 08:35 PM April 30, 2025 01:45 AM
Primary Outcomes (Explanation) 1.here will be significant reduction in psychological distress after 12 sessions of CBT based intervention among women with PCOS 2.There will be significant improvement in coping skills after 12 sessions of CBT based intervention among women with PCOS 3.There will be significant reduction in psychological distress of women with PCOS in experimental group as compared to waiting list group after 12 sessions of CBT based intervention. 4.There will be significant improvement in coping skills of women with PCOS in experimental group as compared to waiting list group after 12 sessions of CBT based intervention.
Secondary Outcomes (Explanation) 1. There will be a significant improvement in body image, self-esteem and the quality of life after 12 sessions of CBT based intervention among women with PCOS 2. There will be a significant reduction in interpersonal sensitivity after 12 sessions of CBT based intervention among women with PCOS 3. There will be a significant improvement in body image, self-esteem and the quality of life of women with PCOS in the experimental group as compared to waiting list group after 12 sessions of CBT based intervention. 4. There will be a significant reduction in interpersonal sensitivity of women with PCOS in the experimental group as compared to waiting list group after 12 sessions of CBT based intervention.
Back to top