Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

Not Applicable

Completed

Conditions: Insomnia

Interventions: Behavioral: Cognitive Behavioral Therapy for Insomnia
Behavioral: Deprescribing

Registration Number: NCT05027438

Lead Sponsor: VA Office of Research and Development

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 36

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 & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
COAST + Deprescribing	Cognitive Behavioral Therapy for Insomnia	CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform
COAST + Deprescribing	Deprescribing	CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform

Primary Outcome Measures

Name	Time	Method
Insomnia Severity Index (ISI) Change	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.
Sedative-Hypnotic Medication Use Change	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)

Secondary Outcome Measures

Name	Time	Method
Sedative-Hypnotic Medication Cessation	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)
Sleep Diary - Sleep Onset Latency (SOL) Change	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).
Sleep Diary - Wake After Sleep Onset (WASO) Change	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).
Sleep Diary - Sleep Efficiency Change	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).
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)	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).
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)	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.