Insomnia Behavioral Intervention Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-10

Study Completion Date

2028-05-20

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.

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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.

Conditions

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Chronic Insomnia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Behavioral approach 1

This includes sleep hygiene and other elements to serve as an experimental arm; subjects will receive a clinically proven therapeutic intervention.

Group Type EXPERIMENTAL

Experimental: Behavioral approach 1

Intervention Type BEHAVIORAL

Includes changing sleep habits and cognitions around sleep from a mental level

Behavioral approach 2

This includes sleep hygiene and other elements to serve as an active comparator; subjects will receive a clinically proven therapeutic intervention.

Group Type ACTIVE_COMPARATOR

Comparator: Behavioral approach 2

Intervention Type BEHAVIORAL

Includes changing sleep habits and awarenes of sleep from a perception level

Interventions

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Experimental: Behavioral approach 1

Includes changing sleep habits and cognitions around sleep from a mental level

Intervention Type BEHAVIORAL

Comparator: Behavioral approach 2

Includes changing sleep habits and awarenes of sleep from a perception level

Intervention Type BEHAVIORAL

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.

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No