Behavioral Treatment of Menopausal Insomnia; Sleep and Daytime Outcomes

Christopher Drake

Status: Completed

Conditions: Menopause

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia; Behavioral: Sleep Education; Behavioral: Sleep Restriction Therapy

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01933295

NR013959

R01NR013959-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

Insomnia is recognized as the most prevalent and "costly" sleep disorders and is associated with considerable morbidity including significantly reduced quality of life, impaired work performance, and increased risk for major depressive disorder.1-4 Insomnia is a key symptom of the menopausal transition. Cognitive-behavioral therapy for insomnia (CBT-I) yields equivalent short-term efficacy and superior long-term durability to pharmacological treatment of insomnia. The efficacy of cognitive behavioral therapy for insomnia comorbid with menopause will be tested.

Full description

Specific Aim 1: Determine the efficacy of multi-component CBT-I compared to a wait-list control group on self report and laboratory-based polysomnographic (PSG) sleep parameters. We hypothesize that multicomponent CBT-I will increase sleep efficiency, reduce the frequency of awakenings, reduce wake after sleep onset, and increase sleep bout duration compared to the control group evaluated using polysomnographic (PSG) and self-report measures of sleep.

Specific Aim 2a: Test the efficacy of a brief two week single component sleep restriction therapy (SRT) to a wait-list control group on PSG and self-report sleep measures (sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration). We hypothesize that brief SRT will be efficacious compared to the control condition in women with menopausal-related insomnia.

Specific Aim 2b: Test the comparability (non-inferiority analysis) of SRT to CBT-I. We hypothesize that SRT will produce comparable efficacy in terms of the PSG and self-report measures of sleep compared to CBT-I (primary endpoints: sleep efficiency, frequency of awakenings, wake after sleep onset, and sleep bout duration).

Specific Aim 3: Determine if CBT-I and SRT improves specific aspects of daytime functioning in patients with menopausal-related insomnia. We hypothesize that patients treated with CBT-I or SRT will have greater improvements in depressive symptomatology, quality of life, sleepiness and fatigue compared with a wait list control group.

Enrollment: 154 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• post-menopausal insomnia

Exclusion criteria

• unstable medical conditions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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154 participants in 3 patient groups

Sleep Education

Active Comparator group

Description:

Weekly educational emails sent to participants with information about sleep science and tips for better sleep.

Treatment:

Behavioral: Sleep Education

Cognitive Behavioral Therapy for Insomnia

Experimental group

Description:

Behavioral treatment (5 component)

Treatment:

Behavioral: Cognitive Behavioral Therapy for Insomnia

Sleep Restriction Therapy

Experimental group

Description:

Brief sleep restriction therapy.

Treatment:

Behavioral: Sleep Restriction Therapy