Objective and subjective vasomotor symptom outcomes in the CBT-Meno randomized controlled trial

Abstract

Objective: Vasomotor symptoms (hot flashes, night sweats) are common during the menopausal transition. Pharmacotherapy is effective but is associated with health risks for some women. There is an increasing demand for non-pharmacological interventions. The CBT-Meno protocol is a psychological intervention targeting a range of common menopausal symptoms. We compared the impact of CBT-Meno vs. waitlist on objective and subjective measures of vasomotor symptoms and on the relationship between vasomotor symptoms and sleep difficulties.

Materials: The participants were 36 perimenopausal or postmenopausal women with co-occurring depressive symptoms who participated in the CBT-Meno trial (clinicaltrials.gov NCT02480192). Subjective measures included the Hot Flash Related Daily Interference Scale, the Greene Climacteric Scale, and the Pittsburgh Sleep Quality Inventory. Objective (physiological) and ‘in-the-moment’ measures of vasomotor symptoms were assessed with sternal skin conductance.

Results: Greater improvements in vasomotor ‘bothersomeness’ and ‘interference’ were observed in the CBT-Meno condition compared to the waitlist condition. No between-group differences were observed in vasomotor frequency (subjectively or objectively recorded) or severity ratings. Sleep disturbance was unrelated to objectively measured vasomotor symptom frequency.

Conclusion: The CBT-Meno trial improved subjective but not objective (physiological) measures of vasomotor symptoms. Self-reported sleep difficulties were unrelated to subjective or objective vasomotor symptoms.

摘要

目的：血管舒缩症状(潮热、盗汗)在绝经过渡期中是很常见的症状。药物能有效的治疗血管舒缩症状, 但对某些女性来说药物可能对健康造成一定风险。因此, 对血管舒缩症状非药物治疗的需求日益增加。CBT-Meno是针对一系列常见更年期症状的心理干预方案。我们比较了CBT-Meno方案与观察方案对血管舒缩症状客观和主观指标的影响, 以及血管舒缩症状与睡眠困难之间关系。

材料：36名伴有抑郁症状的围绝经期或绝经后妇女参加了CBT-Meno试验 (Clinicaltrials.gov NCT02480192)。主观测量指标包括潮热相关的日常干预量表、格林更年期量表和匹兹堡睡眠质量问卷。用胸骨皮肤电导率评估客观（生理）指标和“即时”测量血管舒缩症状。

结果：与观察方案相比, 血管舒缩症状的困扰在CBT-Meno的病患中有更多的改善。在血管舒缩症状的频率（主观或客观记录）或严重程度评分上均未观察到两组间差异。睡眠障碍与客观测量的血管舒缩症状频率无关。

结论：CBT-Meno试验改善了组中患者血管舒缩症状的主观感受, 但客观（生理）测量结果没有变化。主诉的睡眠困难与主观或客观血管舒缩症状无关。

Keywords:

• Vasomotor symptoms
• menopause
• objective measures
• subjective measures
• cognitive behavioral therapy

Acknowledgements

The authors thank Arela Agako, who was a research assistant supported by the study grant and who provided substantial administrative support. They also thank Jee Su Suh and Amna Ursani for their help with data coding. Finally, the authors thank all of the clinical and administrative staff of the Women’s Health Concerns Clinic, St. Joseph’s Healthcare Hamilton.

Author contributions

S. M. Green, B. N. Frey, D. M. Fedorkow, D. L. Streiner, and R. E. McCabe participated in conceptualizing and planning the design and procedures for this study. All authors participated in data acquisition and study implementation, with S. M. Green, B. N. Frey, and R. E. McCabe providing supervision of the implementation of study procedures. S. M. Green, E. Donegan, and D. L. Streiner participated in data analysis and interpretation. All authors participated in manuscript writing and revision.

Potential conflict of interest

The authors declare that they have no conflict of interest.

Source of funding

Funding for this study was obtained by S. M. Green (PI), B. N. Frey, D. M. Fedorkow, and R. E. McCabe from the Ontario Mental Health Foundation (Type A Grant). The funding source did not have any role in the design and conduct of the study; in the collection, management, analysis, or interpretation of the data; or in the preparation, review, or approval of the manuscript.