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Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Primary Purpose

Menopause, Insomnia, Hot Flashes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

CBT for Menopausal Insomnia (CBTMI)

About this trial

This is an interventional treatment trial for Menopause focused on measuring Menopause, Insomnia, Hot Flashes

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

University of Texas Medical Branch

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

CBT for Menopausal Insomnia (CBTMI)

Enhanced Treatment as Usual

Arm Description

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

In 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.

Outcomes

Primary Outcome Measures

Insomnia Severity Index (ISI)

Hot Flash Severity Diaries

Secondary Outcome Measures

Menopause Quality of Life Scale total score

Full Information

NCT ID

NCT02092844

First Posted

January 31, 2014

Last Updated

May 11, 2017

Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

1. Study Identification

Unique Protocol Identification Number

NCT02092844

Brief Title

Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Official Title

Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

September 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The University of Texas Medical Branch, Galveston

Collaborators

National Institutes of Health (NIH), National Institute of Nursing Research (NINR)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

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: 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Menopause, Insomnia, Hot Flashes

Keywords

Menopause, Insomnia, Hot Flashes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CBT for Menopausal Insomnia (CBTMI)

Arm Type

Experimental

Arm Description

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

Arm Title

Enhanced Treatment as Usual

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

CBT for Menopausal Insomnia (CBTMI)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Insomnia Severity Index (ISI)

Time Frame

≤2 weeks after therapy completion

Title

Hot Flash Severity Diaries

Time Frame

Baseline, Post treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up

Secondary Outcome Measure Information:

Title

Menopause Quality of Life Scale total score

Time Frame

Baseline, Post-treatment (≤2 weeks after therapy completion), 1 month and 3 month follow-up

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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 polysomnography (PSG) following screening visit.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Sara Nowakowski, Ph.D.

Organizational Affiliation

University of Texas

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Texas Medical Branch

City

Galveston

State/Province

Texas

ZIP/Postal Code

77555-0144

Country

United States

12. IPD Sharing Statement

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Cognitive Behavioral Therapy for Insomnia and Nocturnal Hot Flashes in Menopause

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