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

March 24, 2025 updated by: VA Office of Research and Development

SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15240
        • VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COAST + Deprescribing
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform
Behavioral: Cognitive Behavioral Therapy for Insomnia
A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
Other Names:
  • CBT-I
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
Other Names:
  • Gradual Dose Reduction, Tapering

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insomnia Severity Index (ISI) Change
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Total score (0-28): no insomnia (0-7); sub-threshold (8-14); moderate (15-21); and severe insomnia (22-28). A reduction pre- to post-treatment/follow-up of 8 points (or more) indicate a treatment response and a post-treatment/follow-up score or 7 (or less) indicate remission.
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sedative-Hypnotic Medication Use Change
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Change in dose % from baseline (T0; week 0) to post-treatment (T1; week 12)

Change in dose % from baseline (T0; week 0) to 3-month follow-up (T2; week 24)
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep Diary - Sleep Onset Latency (SOL) Change
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors:

Sleep Onset Latency (SOL) is the subjective estimate of time it takes to fall asleep after going to bed and turning the lights out (or attempting to go to sleep). SOL is measured in minutes (lower values are better).
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Wake After Sleep Onset (WASO) Change
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors:

Wake After Sleep Onset (WASO) is the subjective estimate of time awake in the middle of the night, after falling asleep and before final rise time/out of bed. WASO is measured in minutes (lower values are better).
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Sleep Efficiency Change
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

The Sleep Diary measures common sleep variables important for tracking and changing sleep behaviors:

Sleep Efficiency (SE) = (total sleep time [TST] / time in bed [TIB]) x 100. SE is measured as a percentage (range 0-100%; higher values are better).
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sedative-Hypnotic Medication Cessation
Time Frame: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24)
post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Includes constructs of Physical Function, Participation in Social Roles, Anxiety, Depression, Fatigue, Sleep Disturbance, Pain Interference and Intensity, and Cognitive Function. Constructs are scored individually (4 items, 4-20) except Cognitive Function (2 items, 2-10).

T-score: population mean=50 and a standard deviation=10. A higher PROMIS T-score represents more of the concept being measured. For negatively-worded concepts like Anxiety, Depression, Sleep, Pain, and Fatigue, a T-score of 60 is one SD worse than average. By comparison, an Anxiety T-score of 40 is one SD better than average. However, for positively-worded concepts like Physical Function, Cognitive Function, and Social Roles, a T-score of 60 is one SD better than average while a T-score of 40 is one SD worse than average.

When all constructs are scored together, a preference score is calculated, representing health-related quality of life ranging from 0 (as bad as dead) to 1 (perfect or ideal health).
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)
Time Frame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
The PROMIS-29+2 Profile v2.1 (PROPr) is used to calculate a preference score (PROMIS Preference, PROPr). Preference-based scores provide an overall summary of health-related quality of life on a common metric. Preference-based scores summarize multiple domains on a metric ranging from 0 (as bad as dead) to 1 (perfect or ideal health). Scores can be used in comparisons across groups and for cost-utility analyses. The profile includes all items in the PROMIS-29 Profile v2.1 plus two Cognitive Function Abilities items. T-scores from the measure can be used to calculate a preference-based score.
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

VA Office of Research and Development

Investigators

  • Principal Investigator: Adam D. Bramoweth, PhD, VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 22, 2022

Primary Completion (Actual)

March 31, 2024

Study Completion (Actual)

June 30, 2024

Study Registration Dates

First Submitted

August 20, 2021

First Submitted That Met QC Criteria

August 27, 2021

First Posted (Actual)

August 30, 2021

Study Record Updates

Last Update Posted (Actual)

April 11, 2025

Last Update Submitted That Met QC Criteria

March 24, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

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

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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