NCT02092844

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 31, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
10 months until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

May 12, 2017

Status Verified

October 1, 2016

Enrollment Period

1.7 years

First QC Date

January 31, 2014

Last Update Submit

May 11, 2017

Conditions

MenopauseInsomniaHot Flashes

Keywords

MenopauseInsomniaHot Flashes

Outcome Measures

Primary Outcomes (2)

  • Insomnia Severity Index (ISI)

    ≤2 weeks after therapy completion

  • Hot Flash Severity Diaries

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

Secondary Outcomes (1)

  • Menopause Quality of Life Scale total score

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

Study Arms (2)

CBT for Menopausal Insomnia (CBTMI)

EXPERIMENTAL

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

Behavioral: CBT for Menopausal Insomnia (CBTMI)

Enhanced Treatment as Usual

PLACEBO COMPARATOR

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.

Behavioral: CBT for Menopausal Insomnia (CBTMI)

Interventions

CBT for Menopausal Insomnia (CBTMI)BEHAVIORAL

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.

CBT for Menopausal Insomnia (CBTMI)Enhanced Treatment as Usual

Eligibility Criteria

Age40 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas Medical Branch

Galveston, Texas, 77555-0144, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersHot Flashes

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Sara Nowakowski, Ph.D.

    University of Texas

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 31, 2014

First Posted

March 20, 2014

Study Start

January 1, 2015

Primary Completion

September 1, 2016

Study Completion

November 1, 2016

Last Updated

May 12, 2017

Record last verified: 2016-10

Locations

US(1)