Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
SEDATIVE
SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)
2 other identifiers
interventional
36
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2022
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 20, 2021
CompletedFirst Posted
Study publicly available on registry
August 30, 2021
CompletedStudy Start
First participant enrolled
September 22, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2024
CompletedResults Posted
Study results publicly available
April 11, 2025
CompletedApril 11, 2025
March 1, 2025
1.5 years
August 20, 2021
March 4, 2025
March 24, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insomnia Severity Index (ISI) Change
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
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 Outcomes (6)
Sedative-Hypnotic Medication Cessation
post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Sleep Onset Latency (SOL) Change
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Wake After Sleep Onset (WASO) Change
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Sleep Diary - Sleep Efficiency Change
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) Change
baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
- +1 more secondary outcomes
Study Arms (1)
COAST + Deprescribing
EXPERIMENTALCBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform
Interventions
A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies
The reduction or withdrawal of a medication, through gradual dose reduction, managed by a healthcare professional that aims to reduce harm and improve outcomes
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Pittsburgh, Pennsylvania, 15240, United States
Related Publications (1)
Bramoweth AD, Hough CE, McQuillan AD, Spitznogle BL, Thorpe CT, Lickel JJ, Boudreaux-Kelly M, Hamm ME, Germain A. Reduction of Sleep Medications via a Combined Digital Insomnia and Pharmacist-Led Deprescribing Intervention: Protocol for a Feasibility Trial. JMIR Res Protoc. 2023 Jul 20;12:e47636. doi: 10.2196/47636.
PMID: 37471122BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Drop out during intervention and failure to complete post-treatment and follow-up assessments resulted in smaller number of subjects analyzed.
Results Point of Contact
- Title
- Adam Bramoweth, PhD (Principal Investigator)
- Organization
- VA Pittsburgh Healthcare System
Study Officials
- PRINCIPAL INVESTIGATOR
Adam D. Bramoweth, PhD
VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 20, 2021
First Posted
August 30, 2021
Study Start
September 22, 2022
Primary Completion
March 31, 2024
Study Completion
June 30, 2024
Last Updated
April 11, 2025
Results First Posted
April 11, 2025
Record last verified: 2025-03
Data Sharing
- IPD Sharing
- Will not share