Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

This study aims to develop and evaluate a primary care-based intervention for insomnia and
nocturnal hot flashes (nHF) in peri- and postmenopausal women. Menopause-associated insomnia
is associated with adverse consequences including reduced quality of life, increased health
care utilization, and risk for psychiatric disorders and medical conditions. The poor
benefit/risk ratio of estrogen and progesterone replacement therapy and concerns about
long-term effects of sedative hypnotics has left women desperate for new approaches to
resolve menopause-related health problems, including poor sleep. The proposed intervention
aims to develop and evaluate a much-needed safe treatment of menopause-associated insomnia
that combines and enhances cognitive behavioral therapies for insomnia and hot flashes. To
maximize the public health impact, improve access, and reduce treatment barriers (stigma and
transportation issues), we propose to evaluate the efficacy and effectiveness of the
intervention delivered by nurses in gynecology clinics, where women receive routine care.
Primary outcomes, for which the study is optimally designed and sufficiently powered, are
subjectively- and objectively-measured sleep and nHF.

The Aims of this research are to:

1. To explore feasibility, acceptability (willingness to be randomized and dropout rates)
of CBTMI, and indications of efficacy/effectiveness of CBTMI in a randomized,
placebo-controlled, pilot study.

2. To explore the effects of CBTMI on the number and duration of arousals/awakenings that
follow nHFs. If effective, the intervention has the potential to improve the quality of
life in peri- and postmenopausal women and reduce the significant costs to society.

Inclusion Criteria:

- Women in menopausal transition (defined by standardized criteria as variable cycle
length seven days different from their normal cycle or >2 skipped cycles and an
interval of amenorrhea of 2-12 months) or postmenopausal (defined as >12 months since
last menstrual period).

- Meet Diagnostic and Statistical Manual of Mental Disorders IV (DSM-IV) criteria for
insomnia assessed by Duke Structured Interview for Sleep Disorders.

- Score >14 on the Insomnia Severity Index (ISI) or >8 on the Pittsburgh Sleep Quality
Index (PSQI).

- Have at least one nocturnal hot flash/night sweat on 3 or more nights a week (based
on 2 weeks of daily hot flash diaries).

Exclusion Criteria:

- Chemotherapy/radiation-induced menopause.

- Presence of any unstable medical disorder assessed by medical tracking form.

- Traumatic brain injury or cognitive impairment defined by a score < 25 on Mini Mental
Status Exam.

- Evidence of recent severe mental health disorders (e.g., suicide attempt or
psychiatric hospitalization in past 3 years).

- Presence of psychotic disorder, substance abuse or dependence, or bipolar disorder,
assessed by MINI International Neuropsychiatric Inventory (to increase
generalizability other psychiatric comorbidities will not be excluded).

- Recent initiation/change in existing treatments that may impact sleep or nocturnal
hot flashes (recency is defined by: < 4 weeks for antidepressant, < 16 weeks for any
psychotherapy, and <8 weeks for estrogen, progestin, or androgen).

- As needed use of hypnotic, over-the-counter, or herbal supplements known to affect
sleep or hot flashes.

- The following comorbid sleep disorders based on structured diagnostic interview:
narcolepsy, circadian rhythm disorder, restless less syndrome, periodic leg movement
disorder (PLMD), obstructive sleep apnea (OSA), or positive screening PLMD (PLMI >
15) or OSA (AHI > 15) on polysomnography (PSG) following screening visit.