Clinical trial NCT05027438: Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention
Official title: SEdative-Hypnotic Deprescribing Assisted by a Technology-Driven Insomnia InterVEntion (SEDATIVE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Keywords: Insomnia
Veterans
Hypnotics and Sedatives
Deprescribing
Cognitive Behavioral Therapy for Insomnia
Telemedicine
Mobile Applications
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2021-08-30
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: pre-post design
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Insomnia Severity Index (ISI) Change
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
measure: Sedative-Hypnotic Medication Use Change
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Secondary outcomes:
measure: Sedative-Hypnotic Medication Cessation
timeFrame: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
measure: Sleep Diary - Sleep Onset Latency (SOL) Change
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
measure: Sleep Diary - Wake After Sleep Onset (WASO) Change
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
measure: Sleep Diary - Sleep Efficiency Change
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
measure: Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
measure: Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)
timeFrame: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
state: Pennsylvania
Study officials:
affiliation: VA Pittsburgh Healthcare System University Drive Division, Pittsburgh, PA
name: Adam D. Bramoweth, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.