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Menopause | Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Menopause research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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.

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Menopause

Insomnia

Hot Flashes

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Behavioral:CBT for Menopausal Insomnia (CBTMI)Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI) includes education about sleep, sleep restriction, stimulus control, cognitive restructuring of sleep interfering thoughts, and relapse prevention; while also addressing women's beliefs about and reactions to hot flashes.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

CBT for Menopausal Insomnia (CBTMI)CBTMI is a combination of Cognitive Behavioral Therapy for Insomnia (CBTI) and Cognitive Behavioral Therapy for Hot Flashes (CBTH).

Enhanced Treatment as UsualIn the Enhanced Treatment as Usual/Information Control group, participants continue with clinical care of their choosing, but will be enhanced by the provision of 3 American Academy of Sleep Medicine (AASM) brochures.

Study Status

Completed

Start Date: January 2015

Completed Date: November 2016

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Insomnia Severity Index (ISI)

Secondary Outcome: Menopause Quality of Life Scale total score

Study sponsors, principal investigator, and references

Principal Investigator: Sara Nowakowski, Ph.D.

Lead Sponsor: The University of Texas Medical Branch, Galveston

Collaborator: National Institutes of Health (NIH)

More information:https://clinicaltrials.gov/show/NCT02092844

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