Trial Outcomes & Findings for Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention (NCT NCT05027438)

NCT ID: NCT05027438

Last Updated: 2025-04-11

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

36 participants

Primary outcome timeframe

baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Results posted on

2025-04-11

Participant Flow

Participant milestones

Participant milestones
Measure
COAST + Deprescribing
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Intervention
STARTED
36
Intervention
COMPLETED
25
Intervention
NOT COMPLETED
11
Post-Treatment
STARTED
25
Post-Treatment
COMPLETED
24
Post-Treatment
NOT COMPLETED
1
3-month Follow-Up
STARTED
24
3-month Follow-Up
COMPLETED
19
3-month Follow-Up
NOT COMPLETED
5

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Reducing Use of Sleep Medications Assisted by a Digital Insomnia Intervention

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
COAST + Deprescribing
n=36 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Age, Continuous
59.22 years
STANDARD_DEVIATION 13.97 • n=5 Participants
Sex: Female, Male
Female
3 Participants
n=5 Participants
Sex: Female, Male
Male
33 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=5 Participants
Race (NIH/OMB)
White
31 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Marital Status
Married
23 Participants
n=5 Participants
Marital Status
Divorced
8 Participants
n=5 Participants
Marital Status
Never Married
3 Participants
n=5 Participants
Marital Status
Widowed
1 Participants
n=5 Participants
Marital Status
Unknown
1 Participants
n=5 Participants
Military Branch
Army
15 Participants
n=5 Participants
Military Branch
Marine Corps
8 Participants
n=5 Participants
Military Branch
Navy
6 Participants
n=5 Participants
Military Branch
Air Force
5 Participants
n=5 Participants
Military Branch
Coast Guard
1 Participants
n=5 Participants
Military Branch
Unknown
1 Participants
n=5 Participants
Combat Exposure
Yes
21 Participants
n=5 Participants
Combat Exposure
No
15 Participants
n=5 Participants

PRIMARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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.

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=35 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Insomnia Severity Index (ISI) Change
Baseline
14.63 score on a scale
Standard Deviation 4.04
Insomnia Severity Index (ISI) Change
Post-Treatment
6.13 score on a scale
Standard Deviation 4.10
Insomnia Severity Index (ISI) Change
3-month Follow-Up
7.17 score on a scale
Standard Deviation 3.59

PRIMARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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)

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=22 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Sedative-Hypnotic Medication Use Change
baseline
100 % medication dose relative to baseline
Standard Deviation 0
Sedative-Hypnotic Medication Use Change
post-treatment
41.45 % medication dose relative to baseline
Standard Deviation 43.98
Sedative-Hypnotic Medication Use Change
3-month follow-up
37.74 % medication dose relative to baseline
Standard Deviation 54.93

SECONDARY outcome

Timeframe: post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

Percentage of participants that stopped using sleep medications at post-treatment (T1; week 12) and 3-month follow-up (T2; week 24)

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=22 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Sedative-Hypnotic Medication Cessation
post-treatment
7 Participants
Sedative-Hypnotic Medication Cessation
3-month follow-up
12 Participants

SECONDARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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).

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=36 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Sleep Diary - Sleep Onset Latency (SOL) Change
baseline
34.19 minutes
Standard Deviation 27.73
Sleep Diary - Sleep Onset Latency (SOL) Change
post-treatment
20.02 minutes
Standard Deviation 14.50
Sleep Diary - Sleep Onset Latency (SOL) Change
3-month follow-up
20.11 minutes
Standard Deviation 16.46

SECONDARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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).

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=36 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Sleep Diary - Wake After Sleep Onset (WASO) Change
baseline
26.04 minutes
Standard Deviation 31.90
Sleep Diary - Wake After Sleep Onset (WASO) Change
post-treatment
14.68 minutes
Standard Deviation 14.96
Sleep Diary - Wake After Sleep Onset (WASO) Change
3-month follow-up
11.04 minutes
Standard Deviation 14.58

SECONDARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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).

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=36 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Sleep Diary - Sleep Efficiency Change
baseline
87 sleep efficiency (%)
Standard Deviation 9
Sleep Diary - Sleep Efficiency Change
post-treatment
93 sleep efficiency (%)
Standard Deviation 5
Sleep Diary - Sleep Efficiency Change
3-month follow-up
94 sleep efficiency (%)
Standard Deviation 5

SECONDARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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).

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=36 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
n=24 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
n=15 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Anxiety
51.58 T-score
Standard Deviation 8.18
48.48 T-score
Standard Deviation 8.51
48.39 T-score
Standard Deviation 7.96
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Cognitive Function
45.46 T-score
Standard Deviation 5.94
48.46 T-score
Standard Deviation 7.60
49.98 T-score
Standard Deviation 4.62
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Depression
50.74 T-score
Standard Deviation 8.77
49.08 T-score
Standard Deviation 8.32
46.75 T-score
Standard Deviation 6.01
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Fatigue
56.31 T-score
Standard Deviation 7.99
50.90 T-score
Standard Deviation 9.17
46.93 T-score
Standard Deviation 8.50
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Pain Interference/Intensity
57.74 T-score
Standard Deviation 6.93
56.53 T-score
Standard Deviation 7.41
53.23 T-score
Standard Deviation 6.38
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Physical Function
42.90 T-score
Standard Deviation 7.30
45.40 T-score
Standard Deviation 6.07
47.67 T-score
Standard Deviation 6.64
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Sleep Disturbance
58.48 T-score
Standard Deviation 6.11
50.10 T-score
Standard Deviation 6.29
49.99 T-score
Standard Deviation 5.22
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) Change
Ability to Participate in Social Roles
49.07 T-score
Standard Deviation 8.50
54.36 T-score
Standard Deviation 8.60
57.53 T-score
Standard Deviation 6.63

SECONDARY outcome

Timeframe: baseline (T0; week 0), post-treatment (T1; week 12), 3 month follow-up (T2; week 24)

Population: intent to treat analysis - time frame sample size differs due to drop out

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.

Outcome measures

Outcome measures
Measure
COAST + Deprescribing
n=36 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - Post-Treatment
n=24 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
COAST + Deprescribing - 3-Month Follow-Up
n=14 Participants
CBT-I with simultaneous sedative-hypnotic deprescribing delivered through a digital platform Cognitive Behavioral Therapy for Insomnia: A multimodal psychotherapy that may include stimulus control, sleep restriction, cognitive therapy, psychoeducation, and relaxation strategies 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
Patient-Reported Outcomes Measurement Information System Adult Profile (PROMIS 29+2) - PROMIS Preference (PROPr)
0.29 score 0-1
Standard Deviation 0.16
0.41 score 0-1
Standard Deviation 0.19
0.50 score 0-1
Standard Deviation 0.15

Adverse Events

COAST + Deprescribing

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adam Bramoweth, PhD (Principal Investigator)

VA Pittsburgh Healthcare System

Phone: (412) 360-2806

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place