David A Kalmbach1, Philip Cheng1, J Todd Arnedt2, Jason R Anderson3, Thomas Roth1, Cynthia Fellman-Couture1, Reg A Williams2, Christopher L Drake4. 1. Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. 2. Department of Psychiatry, University of Michigan Medical School, Ann Arbor, MI, USA. 3. Department of Psychological Sciences, Kent State University, Kent, OH, USA. 4. Thomas Roth Sleep Disorders & Research Center, Henry Ford Health System, Detroit, MI, USA. Electronic address: cdrake1@hfhs.org.
Abstract
INTRODUCTION: Depression increases during menopause, and subclinical depressive symptoms increase risk for major depression. Insomnia is common among postmenopausal women and increases depression-risk in this already-vulnerable population. Recent evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBTI) to treat menopausal insomnia, but it remains unclear whether treating insomnia also alleviates co-occurring depressive symptoms and depressogenic features. This trial tested whether CBTI improves depressive symptoms, maladaptive thinking, and somatic hyperarousal in postmenopausal women with insomnia; as well as whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious. MATERIALS AND METHODS: Single-site, randomized controlled trial. 117 postmenopausal women (56.34 ± 5.41 years) with peri-or-postmenopausal onset of chronic insomnia were randomized to three treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at baseline, posttreatment, and six-month follow-up. RESULTS:CBTI produced moderate-to-large reductions in depressive symptoms, whereas SRT produced moderate reductions but not until six months posttreatment. Treatment effects on maladaptive thinking were mixed. CBTI and SRT both produced large improvements in dysfunctional beliefs about sleep, but weaker influences on presleep cognitive arousal, rumination, and worry. Presleep somatic arousal greatly improved in the CBTI group and moderately improved in the SRT group. Improvements in depression, maladaptive thinking, and hyperarousal were linked to improved sleep. SHE produced no durable treatment effects. CONCLUSIONS:CBTI and SRT reduce depressive symptoms, dysfunctional beliefs about sleep, and presleep somatic hyperarousal in postmenopausal women, with CBTI producing superior results. Despite its cognitive emphasis, cognitive arousal did not respond strongly or durably to CBTI. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. REGISTRATION: NCT01933295.
RCT Entities:
INTRODUCTION:Depression increases during menopause, and subclinical depressive symptoms increase risk for major depression. Insomnia is common among postmenopausal women and increases depression-risk in this already-vulnerable population. Recent evidence supports the efficacy of cognitive-behavioral therapy for insomnia (CBTI) to treat menopausal insomnia, but it remains unclear whether treating insomnia also alleviates co-occurring depressive symptoms and depressogenic features. This trial tested whether CBTI improves depressive symptoms, maladaptive thinking, and somatic hyperarousal in postmenopausal women with insomnia; as well as whether sleep restriction therapy (SRT)-a single component of CBTI-is equally efficacious. MATERIALS AND METHODS: Single-site, randomized controlled trial. 117 postmenopausal women (56.34 ± 5.41 years) with peri-or-postmenopausal onset of chronic insomnia were randomized to three treatment conditions: sleep hygiene education control (SHE), SRT, and CBTI. Blinded assessments were performed at baseline, posttreatment, and six-month follow-up. RESULTS:CBTI produced moderate-to-large reductions in depressive symptoms, whereas SRT produced moderate reductions but not until six months posttreatment. Treatment effects on maladaptive thinking were mixed. CBTI and SRT both produced large improvements in dysfunctional beliefs about sleep, but weaker influences on presleep cognitive arousal, rumination, and worry. Presleep somatic arousal greatly improved in the CBTI group and moderately improved in the SRT group. Improvements in depression, maladaptive thinking, and hyperarousal were linked to improved sleep. SHE produced no durable treatment effects. CONCLUSIONS:CBTI and SRT reduce depressive symptoms, dysfunctional beliefs about sleep, and presleep somatic hyperarousal in postmenopausal women, with CBTI producing superior results. Despite its cognitive emphasis, cognitive arousal did not respond strongly or durably to CBTI. NAME: Behavioral Treatment of Menopausal Insomnia: Sleep and Daytime Outcomes. URL: clinicaltrials.gov. REGISTRATION: NCT01933295.
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