Insomnia Behavioral Intervention Study

Study Overview
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Brief Summary
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This randomized pilot study (n=20) explores the effects of a behavioral intervention, that includes sleep hygiene improvements, in long-term users of sleeping pills, aiming to alleviate or stabilize symptoms of insomnia, monitor and decrease sleeping pill usage. Adherence will be monitored by an optional smartphone application.

Detailed Description
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This randomized pilot study has a goal of enrolling 20 study participants. The investigators will examine the effects of a behavioral intervention, that includes sleep hygiene improvements such as regular sleep schedules, with assisted coaching support from the research team. Study participants are long-term users of sleeping pills. The goal is to improve or stabilizie insomnia symptoms and decrease sleeping pill usage. Study participant adherence will be monitored by an optional smartphone application.

Official Title
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Behavioral Intervention to Reduce Sedative Use in Older Adults With Chronic Insomnia

Conditions
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Chronic Insomnia

Intervention / Treatment
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* Behavioral: Experimental: Behavioral approach 1
* Behavioral: Comparator: Behavioral approach 2


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age of 55-85 Use of sleeping pill medication for sleep at least 3 nights a week Diagnosed with Chronic Insomnia by a physician Speaks English above a 6th-grade level Has access to a smartphone and/or smart tablet and can use it Has regular access to internet Exclusion Criteria: Presence of major depression or other severe psychopathology (e.g., bipolar disorder, psychosis, alcohol/substance abuse, etc.) Presence of an acute or severe medical condition which, in the opinion of the research team, would interfere with the study participant's ability to participate in the research study, such as an acute heart attack, recent severe trauma, etc.

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Behavioral approach 1<br>This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention. | Behavioral: Experimental: Behavioral approach 1<br>* Includes changing sleep habits and cognitions around sleep from a mental level<br>|
| Active Comparator: Behavioral approach 2<br>This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention. | Behavioral: Comparator: Behavioral approach 2<br>* Includes changing sleep habits and awarenes of sleep from a perception level<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Pill Dosage | We will monitor changes in participants' sleep pill total dosage taken over one week using the sleep diary (which includes a daily question regarding sleeping pills used that night). The usage reduction will be calculated as a percent (total weekly usage at end of study divided by total weekly usage during the baseline week). | 28-day follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sleep Efficiency | Sleep efficiency which will be calculated using information from the sleep diary (logged daily from day 0 until day 28). | 28-day follow-up |