Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

36 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-22

Study Completion Date

2024-06-30

Brief Summary

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Chronic insomnia is one of the most common health problems among Veterans and significantly impacts their health, function, and quality of life. Sedative-hypnotic medications are the most common treatment despite mixed effectiveness and are associated with numerous risks that can further impact Veteran function. An intervention combining evidence-based interventions for deprescribing sedative-hypnotics and behavioral interventions for insomnia (e.g., Cognitive Behavioral Therapy for Insomnia \[CBT-I\]) can help to optimize sleep and functional outcomes for Veterans with a desire to reduce or stop using these medications. Furthermore, by delivering these interventions through an easy to use and highly accessible digital platform can provide additional benefits to Veterans, especially those with limited time and access to engage in traditional in-person interventions. The Clinician Operated Assistive Sleep Technology (COAST) is an efficient, scalable, and adaptable platform that can help providers to reach more Veterans and provide evidence-based care that translates to improved health and function.

Aim 1: To assess the feasibility of recruiting Veterans with chronic sedative-hypnotic use to participate in a 12-week combined deprescribing and CBT-I intervention, delivered through the COAST digital platform.

Aim 2: To assess Veteran acceptability and usability of the COAST platform.

Aim 3: To assess change in Veteran sleep, sedative-hypnotic use, and function pre- to post-intervention.

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Detailed Description

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Conditions

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Insomnia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

pre-post design

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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COAST + Deprescribing

CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform

Group Type EXPERIMENTAL

Cognitive Behavioral Therapy for Insomnia

Intervention Type BEHAVIORAL

A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies

Deprescribing

Intervention Type BEHAVIORAL

The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes

Interventions

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Cognitive Behavioral Therapy for Insomnia

A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies

Intervention Type BEHAVIORAL

Deprescribing

The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes

Intervention Type BEHAVIORAL

Other Intervention Names

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CBT-I Gradual Dose Reduction, Tapering

Eligibility Criteria

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Inclusion Criteria

* A Veteran receiving care at VA Pittsburgh Healthcare System
* Active sedative-hypnotic medication use \>14 days/month for \>=3 months
* A desire to reduce or stop using sedative-hypnotic medications
* Access to a mobile device with internet

Exclusion Criteria

* A disorder that would impair participation (e.g., cancer, uncontrolled pain, severe depression)
* A disorder that can be exacerbated by changes in sleep (e.g., seizure disorder, bipolar I disorder)
* High risk of suicide
* An active substance use disorder in past 6 months

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No