Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Completed · Not applicable

Conditions studied: Menopause, Insomnia, Hot Flashes

In brief

The primary aim of the current study is to evaluate the effectiveness of a Cognitive Behavioral Therapy intervention in the treatment of menopause-associated insomnia and nocturnal hot flashes.

Key facts

Study ID

NCT02092844

Run by

The University of Texas Medical Branch, Galveston

People needed

40

Starts

2015-01-01

Expected to finish

2016-11-01

Last updated by the study team

2017-05-12

Who can join

Age: 40 and older, up to 65. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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.

Where it is running

• University of Texas Medical Branch — Galveston, Texas, United States

Full record on ClinicalTrials.gov

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