Cognitive behavioral therapy for menopausal insomnia in perimenopausal and postmenopausal women with insomnia and nocturnal hot flashes: a randomized-controlled pilot trial

Objectives: – The objective of this randomized-controlled pilot trial was to develop and test a cognitive behavioral therapy intervention for both insomnia and vasomotor symptoms (VMS) in perimenopausal and postmenopausal women with insomnia disorder experiencing nocturnal vasomotor symptoms. Methods: – Forty-three participants (mean age = 53.6 y) self-described as perimenopausal or postmenopausal who reported at minimum ≥ 1 nocturnal hot flash/night and met diagnostic criteria for insomnia disorder were randomized to cognitive behavioral therapy for menopausal insomnia (CBT-MI) or menopause education control (MEC). The CBT-I intervention was adapted for the study population by incorporating elements of CBT for menopausal symptoms. Primary outcomes measured at baseline, post-treatment measures, 1-month follow-up, and 3-month follow-up included: Insomnia Severity Index (ISI), Sleep Self-Efficacy Scale (SES), and Hot Flash Daily Interference Scale (HFDIS). Results: – CBT-MI compared with MEC significantly reduced ISI (CBT-MI vs. MEC: −10.2±1.15 vs. −6.2±0.99; P=0.007), HFDIS (CBT-MI vs. MEC: −1.3±0.29 vs. −0.5±0.17; P=0.01), and increased SES (10.2±1.46 vs. 5.9±1.24, P=0.03) post-treatment and 1-month after the end of treatment (ISI: CBT-MI vs. MEC, −10.9±1.19 vs. −6.5±0.98; P=0.003, HFRDIS: CBT-MI vs. MEC, −1.1±0.28 vs. −0.4±0.18, P=0.047, SES: CBT-MI vs. MEC, 11.9±2.06 vs. 5.6±1.25; P=0.003). Analysis of the ISI factors showed that CBT-MI significantly decreased night-time sleep symptoms and patient perception of insomnia at post-treatment and 1-month follow-up compared with MEC. Night-time sleep symptoms remained improved at 3-month follow-up compared with MEC. Conclusions: – In this pilot study, a CBT intervention targeting both insomnia and VMS showed promising improvements in sleep and hot flash interference in midlife women.