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Objectives <p>The purpose of the present study was to compare the effectiveness of Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) combined with lifestyle interventions versus lifestyle interventions alone on the mental health of women with polycystic ovary syndrome (PCOS).</p> Methods <p>Participants were randomly assigned (1:1:1) to one of three groups: (1) P-Milife intervention (MiCBT combined with lifestyle interventions); (2) lifestyle interventions alone; or (3) control. The intervention lasted 8 weeks and was delivered through online and offline individual sessions. Using the intention-to-treat principle, generalized estimating equations (GEE) were employed to assess intervention effects on mental health outcomes.</p> Results <p>The P-Milife intervention significantly reduced anxiety and depressive symptoms in PCOS patients compared to the control group, with mean differences of −3.41 (<i>p</i> &lt; 0.001) and −4.17 (<i>p</i> &lt; 0.001), respectively. It also decreased the odds of concurrent anxiety and depression (<i>OR</i> = 0.210,<i> p</i> &lt; 0.001), facilitated weight loss (mean difference = −0.73&#xa0;kg, <i>p</i> &lt; 0.001), reduced body image distress (mean difference = 3.61, <i>p</i> = 0.001), and improved subjective well-being (mean difference = 1.31, <i>p</i> &lt; 0.001). In contrast, lifestyle interventions alone reduced depressive symptoms (mean difference = −3.27, <i>p</i> &lt; 0.001) and aided in weight management (mean difference = −0.52&#xa0;kg, <i>p</i> &lt; 0.001) but did not significantly impact anxiety or subjective well-being.</p> Conclusions <p>Integrating MiCBT with lifestyle interventions demonstrates superior efficacy in promoting mental health for individuals with PCOS compared to lifestyle intervention alone, offering a novel and holistic strategy for managing this condition. The P-Milife intervention program may support nurses and other healthcare professionals in addressing the mental health concerns of women with PCOS. Further research is needed to confirm these findings.</p> Preregistration <p>This study was retrospectively registered in the Chinese Clinical Trial Registry on 25 April 2023 (ChiCTR2300070851).&#xa0;This randomized controlled trial was registered at the Chinese Clinical Trial Registry, ChiCTR2300070851.</p>

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Impact of Combined Mindfulness-Integrated Cognitive Behavior Therapy and Lifestyle Interventions on Mental Health in Women with Polycystic Ovary Syndrome: A Randomized Controlled Trial

  • 期刊论文

  • 发表日期：

    2025年12月15日

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  • Guangpeng Wang,
  • Minhui Guan,
  • Rong Li,
  • Tan He,
  • Lan Luo,
  • Sijie Hu,
  • Binglu Wang,
  • Dan Liu,
  • Jun Lei

摘要

Objectives

The purpose of the present study was to compare the effectiveness of Mindfulness-integrated Cognitive Behavior Therapy (MiCBT) combined with lifestyle interventions versus lifestyle interventions alone on the mental health of women with polycystic ovary syndrome (PCOS).

Methods

Participants were randomly assigned (1:1:1) to one of three groups: (1) P-Milife intervention (MiCBT combined with lifestyle interventions); (2) lifestyle interventions alone; or (3) control. The intervention lasted 8 weeks and was delivered through online and offline individual sessions. Using the intention-to-treat principle, generalized estimating equations (GEE) were employed to assess intervention effects on mental health outcomes.

Results

The P-Milife intervention significantly reduced anxiety and depressive symptoms in PCOS patients compared to the control group, with mean differences of −3.41 (p < 0.001) and −4.17 (p < 0.001), respectively. It also decreased the odds of concurrent anxiety and depression (OR = 0.210, p < 0.001), facilitated weight loss (mean difference = −0.73 kg, p < 0.001), reduced body image distress (mean difference = 3.61, p = 0.001), and improved subjective well-being (mean difference = 1.31, p < 0.001). In contrast, lifestyle interventions alone reduced depressive symptoms (mean difference = −3.27, p < 0.001) and aided in weight management (mean difference = −0.52 kg, p < 0.001) but did not significantly impact anxiety or subjective well-being.

Conclusions

Integrating MiCBT with lifestyle interventions demonstrates superior efficacy in promoting mental health for individuals with PCOS compared to lifestyle intervention alone, offering a novel and holistic strategy for managing this condition. The P-Milife intervention program may support nurses and other healthcare professionals in addressing the mental health concerns of women with PCOS. Further research is needed to confirm these findings.

Preregistration

This study was retrospectively registered in the Chinese Clinical Trial Registry on 25 April 2023 (ChiCTR2300070851). This randomized controlled trial was registered at the Chinese Clinical Trial Registry, ChiCTR2300070851.