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Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention (SEDATIVE)

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VA Office of Research and Development

Status

Completed

Conditions

Insomnia

Treatments

Behavioral: Deprescribing
Behavioral: Cognitive Behavioral Therapy for Insomnia

Study type

Interventional

Funder types

Other U.S. Federal agency

Identifiers

NCT05027438
1I21RX003732-01A1 (U.S. NIH Grant/Contract)
F3732-P

Details and patient eligibility

About

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.

Enrollment

36 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

36 participants in 1 patient group

COAST + Deprescribing
Experimental group
Description:
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform
Treatment:
Behavioral: Cognitive Behavioral Therapy for Insomnia
Behavioral: Deprescribing

Trial documents
2

Trial contacts and locations

1

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Central trial contact

Caroline E Hough, BA; Adam D Bramoweth, PhD

Data sourced from clinicaltrials.gov

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