Telephone based CBT reduced insomnia severity more than menopause education in menopausal women
Question In perimenopausal or postmenopausal women with insomnia and hot flashes, what is the relative efficacy of telephone based cognitivebehavioral therapy for insomnia (CBT I) and telephone based menopause education control (MEC) for reducing insomnia? Methods Design Randomized controlled trial (RCT) ClinicalTrials.gov NCT01936441. Allocation {Concealed} Blinding Blinded (data collectors) Follow up period 24 weeks. Setting MsFlash research network in western Washington State, USA. Patients 106 perimenopausal and postmenopausal women 40 to 65 years of age (mean age 55 y) who had significant insomnia symptoms (Insomnia Severity Index [ISI] score 12) and 2 hot flashes/d for the past 2 weeks. Exclusion criteria included primary sleep disorder or major illness interfering with sleep, routine use of prescription sleep medication, consumption of >3 alcoholic drinks/d, or shift work. Intervention CBT I (n =53) or MEC (n =53) each of which comprised six 20 to 30 minute telephone sessions led by 2 female coaches over 8 weeks. CBT I included information about age related sleep changes, sleep hygiene, and stimulus control procedures; and teaching about cognitive techniques to reduce physiologic arousal and reduce unrealistic beliefs about sleep loss. Sleep windows were restricted to the average sleep time reported at baseline and extended by 15 minutes weekly when 85% sleep efficiency was achieved. MEC comprised general education and written information about women's health and quality of life, excluding information about CBT strategies for sleep. Outcomes Insomnia severity (ISI) Secondary outcome was Pittsburgh Sleep Quality Index (PSQI) score. Exploratory outcomes included no clinically significant insomnia {ISI} and daily interference of hot flashes (Hot Flash Related Daily Interference Scale) Patient follow up 83% at 8 weeks and 76% at 24 weeks (intention to treat analysis) Main results CBT I reduced insomnia (on the ISI and PSQI) and increased the likelihood of no insomnia at 8 and 24 weeks compared with MEC (Table) CBT I also reduced scores on the Hot Flash Related Daily Interference Scale at 8 (P =0.03) and 24 (P =0.003) weeks compared with MEC. Conclusion In perimenopausal or postmenopausal women with insomnia and hot flashes, telephone based cognitivebehavioral therapy for insomnia reduced insomnia severity compared with telephone based menopause education control. Telephone based CBT I vs MEC in perimenoausal or postmenopausal women with insomnia and hot flashes Outcomes Time points (follow up rate) Mean change from baseline (95% CI) Difference in mean change from baseline (CI) CBT I MEC ISI score 8 wk (83% 9.9 (11.2 to 8.7) 4.7 (6.1 to 3.3) 5.2 (6.1 to 3.3) 24 wk (76% 10.7 (11.9 to 9.4) 6.7 (8.4 to 5.0) 4.0 (6.0 to 1.9) PSQI score 8 wk (83% 4.0 (5.0 to 3.1) 1.4 (2.1 to 0.7) 2.7 (3.9 to 1.5) 24 wk (76% 4.3 (5.1 to 3.5) 2.7 (3.5 to 1.9) 1.6 (2.7 to 0.5) Event rates Relative benefit increase (CI) NNT (CI) No clinically significant insomnia (ISI score 7) 8 wk (83% 70% 24% 188 (70 to 421) 3 (2 to 4) 24 wk (76% 84% 43% 94 (37 to 198) 3 (2 to 5) CBT I cognitivebehavioral therapy for insomnia; ISI Insomnia Severity Index; MEC menopause education control; other abbreviations defined in Glossary. Relative benefit increase, NNT, and CI calculated from event rates in article. Negative difference indicates more improvement in the CBT I group. Score range 0 to 28; higher score more severe insomnia (6 point change is considered clinically meaningful) Score range 0 to 21; higher score worse sleep quality (3 point change is considered clinically meaningful) Commentary Menopause is associated with various physical disorders that adversely affect quality of life, including vasomotor symptoms (VMSs) sleep disturbance, and urogenital atrophy. Although it has potential adverse effects, estrogen remains the single most effective therapy for menopause related VMSs and urogenital atrophy (1) with positive effects on sleep, mood, bone density, cardiovascular health, and other metabolic conditions (2) Other pharmacotherapies (antidepressants, gabapentin, clonidine, herbal medicine) and alternative treatments (psychotherapy, acupuncture, exercise, and yoga) have measurable but less dramatic benefits in terms of VMS and sleep (1) It is not surprising that the RCT by McCurry and colleagues found that specialized CBT reduced insomnia and VMS. Study weaknesses include self assessment of sleep patterns, which could introduce reporting biasthat is, some patients may have been unaware of, or did not report, excessive caffeine use and such conditions as restless leg syndrome or sleep apnea. Additionally, depression, amenable to CBT, may have confounded the findings. The statistically significant, but modest, effect of the intervention on VMS frequency and intensity is probably not clinically significant and may be comparable to placebo in other studies (1) Finally, the study sample was small and from a single region; further study is needed to determine whether CBT is effective in a larger, heterogeneous population requires. Costs, accessibility, and time commitment could be formidable obstacles to widespread adoption. However, structured CBT may offer another choice to the menopausal management armamentarium, particularly for women who have insomnia, are averse to hormonal therapies, or have contraindications.
Annals of Internal Medicine