Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified April 2014 by The University of Texas, Galveston
Sponsor:
Collaborators:
Information provided by (Responsible Party):
The University of Texas, Galveston
ClinicalTrials.gov Identifier:
NCT02092844
First received: January 31, 2014
Last updated: April 10, 2014
Last verified: April 2014
  Purpose

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.


Condition Intervention
Menopause
Insomnia
Hot Flashes
Behavioral: Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Resource links provided by NLM:


Further study details as provided by The University of Texas, Galveston:

Primary Outcome Measures:
  • Insomnia Severity Index (ISI) [ Time Frame: ≤2 weeks after therapy completion ] [ Designated as safety issue: No ]
  • Hot Flash Severity Diaries [ Time Frame: Baseline, Post treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Menopause Quality of Life Scale total score [ Time Frame: Baseline, Post-treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: June 2014
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI)
CBTMI is a combination of Cognitive Behavioral Therapy for Insomnia (CBTI) and Cognitive Behavioral Therapy for Hot Flashes (CBTH). 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.
Behavioral: Cognitive Behavioral Therapy for Menopausal Insomnia (CBTMI)
Placebo Comparator: Enhanced Treatment as Usual/ Information Control
Participants continue with clinical care of their choosing, but will be enhanced by the provision of 3 American Academy of Sleep Medicine (AASM) brochures.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   40 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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 PSG following screening visit.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02092844

Contacts
Contact: Jessica M Meers, M.A. 214-796-8492 jmmeers@utmb.edu

Locations
United States, Texas
University of Texas Medical Branch Not yet recruiting
Galveston, Texas, United States, 77555-0144
Contact: Jessica M Meers, M.A.    214-796-8492    jmmeers@utmb.edu   
Principal Investigator: Sara Nowakowski, Ph.D.         
Sponsors and Collaborators
The University of Texas, Galveston
Investigators
Principal Investigator: Sara Nowakowski, Ph.D. University of Texas
  More Information

No publications provided

Responsible Party: The University of Texas, Galveston
ClinicalTrials.gov Identifier: NCT02092844     History of Changes
Other Study ID Numbers: 13-102, 1K23NR014008
Study First Received: January 31, 2014
Last Updated: April 10, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by The University of Texas, Galveston:
Menopause
Insomnia
Hot Flashes

Additional relevant MeSH terms:
Hot Flashes
Signs and Symptoms

ClinicalTrials.gov processed this record on October 22, 2014