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By Nicole Cirino, MD, CST, IF
Reproductive Psychiatrist, Associate Professor of Psychiatry and OB/GYN, Oregon Health & Science University, Portland
Dr. Cirino reports no financial relationships relevant to this field of study.
SYNOPSIS: In a randomized, controlled trial comparing the behavioral interventions cognitive behavioral therapy for insomnia (CBTI) and sleep reduction therapy (SRT) to a control intervention of sleep hygiene education, investigators found CBTI and SRT therapy improved insomnia and depressive symptoms in postmenopausal women with menopausal-related insomnia.
SOURCE: Kalmbach DA, Cheng P, Arnedt JT, et al. Treating insomnia improves depression, maladaptive thinking, and hyperarousal in postmenopausal women: Comparing cognitive-behavioral therapy for insomnia (CBTI), sleep restriction therapy, and sleep hygiene education. Sleep Med 2019;55:124-134.
Insomnia symptoms are common complaints during the menopausal transition, and up to 50% of women experience these symptoms.1 Menopausal-related insomnia disorder describes insomnia that occurs or is exacerbated during perimenopause or menopause, and is believed to be related to fluctuations in estrogen, progesterone, and cortisol levels. Effective treatments include cognitive behavioral therapy for insomnia (CBTI), sleep reduction therapy (SRT), hormone replacement therapy (HRT), antidepressants, exercise, and yoga.2 Insomnia also is strongly correlated with depressive symptoms in adults. In addition, depressive symptoms arise more often during the menopausal transition. Kalmbach et al attempted to address the effect of CBTI or SRT on insomnia and depressive symptoms in women with menopausal-related insomnia. Behavioral interventions often are considered first-line interventions for insomnia in the general adult population.3 Common behavioral interventions for insomnia include CBTI and SRT. The theory behind the effectiveness of these treatments is that acute insomnia can progress into chronic insomnia because of cognitive arousal (rumination and worry) and dysfunctional beliefs about sleep (catastrophizing negative effects of a poor night’s sleep). CBTI treatments aim to address this component of insomnia comprehensively, while SRT is a unique intervention that is part of the full CBTI protocol that specifically addresses time in bed (TIB).
SRT is a standard behavioral tactic used as part of CBTI and as a standalone intervention. It involves restricting a patient’s TIB (sleep window) to match his or her average self-reported total sleep duration. The sleep window is titrated weekly, based on sleep efficiency (the proportion of TIB spent asleep), to identify the patient’s core sleep requirement. Spielman et al proposed that decreasing a person’s opportunity to sleep across successive nights would build homeostatic sleep pressure, stabilize circadian control of sleep and wakefulness, and dampen presleep cognitive and physiological hyperarousal, which would lead to less time to fall asleep and more consolidated, uninterrupted sleep.4
Kalmbach et al used a single-site, randomized, controlled trial format to randomize 117 postmenopausal women (56.34 ± 5.41 years of age) with peri- or postmenopausal onset of insomnia to one of three treatments: sleep hygiene education, SRT, or CBTI. Exclusion criteria included sleep apnea, restless legs, bipolar disorder, and prior CBTI. Blinded assessments were performed at baseline, post-treatment (approximately six weeks), and six-month follow-up. The authors used the Beck depression inventory, second edition (BDI-II) to measure depression and a variety of scales to assess cognitive and behavioral properties associated with insomnia: dysfunctional beliefs and attitudes about sleep scale (DBAS), presleep arousal scale (PSAS), event-related rumination inventory (ERRI), and Penn State worry questionnaire (PSWQ).
Of the study participants, 3.4% were on HRT and 23.1% underwent medical menopause. Vasomotor or other menopausal symptoms were not elicited and, thus, not used in randomization. In addition, 4.3% of participants reported moderately severe depression at intake (BDI-II > 20) while the average BDI-II was 8.26 ± 5.00 (subclinical depression range). All interventions were offered in a primary care or sleep medicine office-based setting over six weeks in either face-to-face, phone, or email format.
Improvements in insomnia were strongly correlated with improvements in depression and dysfunctional beliefs about sleep in both post-treatment and six-month follow-up. Patients receiving SRT or CBTI both reported lower depressive symptoms six months after completing treatment. SRT patients reported a medium decrease in depressive symptoms, whereas CBTI patients reported a larger decrease in symptoms. The change from pre- to six-month follow-up BDI-II score was -2.91 (P < 0.01) among SRT patients and -5.14 (P < 0.001) in the CBTI group. Sleep hygiene education alone did not produce any durable treatment effects. In fact, depressive symptoms were higher at the six-month follow-up. SRT direct effects on depression were not captured until the six-month follow-up visit. Results showed that compared to sleep hygiene education, short-term specialized behavioral interventions (CBTI and SRT) helped alleviate subclinical depressive symptoms and improve insomnia by reducing maladaptive thinking and somatic hyperarousal.
A paucity of data exists regarding behavioral interventions specifically for insomnia related to menopause, despite its high prevalence in this population. Kalmbach et al described an effective model for a two- to six-session office-based behavioral intervention, which was delivered by a registered nurse under guidance of a licensed mental health professional. Access to evidence-based behavioral interventions for insomnia has been a barrier to treatment in many clinical settings. This intervention could be provided in ambulatory settings for the common complaints of menopausal-related insomnia and depressive symptoms.
This reflects the trend of delivering behavioral insomnia interventions in an integrated medical care setting. The Veterans Administration (VA), which also sees a high prevalence of insomnia in its population but struggles with access, has released an evidence-based online app, the CBT-i Coach. This free, publicly available, patient-facing smartphone app is intended to augment clinician-delivered CBTI by facilitating the delivery of major CBTI treatment components, including sleep educational materials, daily sleep diary completion, stimulus control guidelines, SRT, anxiety management, and cognitive therapy tools.5 It is not specific to the VA population and can be used for general insomnia by anyone.
Studying specific behavioral interventions for insomnia in this population can help identify the most effective interventions for menopausal-related insomnia. Kalmbach et al found that CBTI was most effective, followed by SRT. Sleep hygiene education had no lasting clinical effect on insomnia or depressive symptoms. They did not address which perimenopausal and postmenopausal patients may respond best to this treatment. This population had a high incidence of medically induced menopause. Vasomotor symptomatology, which is correlated with both insomnia and depression, was not elicited. Furthermore, the women in this study had average BDI scores of 8.26 ± 5.00 and were in the subclinical depression range. Since the issue is unclear, it is not yet recommended for insomnia interventions alone to be used to treat those who meet criteria for clinical depression. Obviously, one of the benefits of successful office-based behavioral interventions is the low side effect profile, particularly for women who may not be good candidates for hormone therapy or antidepressant treatment. CBTI and SRT are easy, side effect-free, and effective behavioral treatments for many patients with these common menopausal symptoms. Hopefully, more innovative models of delivery will be available to clinicians in the future.
Financial Disclosure: Internal Medicine Alert’s Physician Editor Stephen Brunton, MD, is a retained consultant for Abbott, Acadia, Allergan, AstraZeneca, Avadel, Boehringer Ingelheim, GlaxoSmithKline, Janssen, Mylan, and Salix; he serves on the speakers bureau of AstraZeneca, Boehringer Ingelheim, Janssen, Lilly, and Novo Nordisk. Peer Reviewer Gerald Roberts, MD; Editor Jonathan Springston; Editorial Group Manager Leslie Coplin; and Accreditations Manager Amy M. Johnson, MSN, RN, CPN, report no financial relationships relevant to this field of study.