Trial Outcomes & Findings for Discontinuation of Hypnotics in Older Veterans (NCT NCT03511209)
NCT ID: NCT03511209
Last Updated: 2024-11-14
Results Overview
The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
6 months after treatment ends (which is an average of 8 months from randomization)
Results posted on
2024-11-14
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBTI) Plus Taper Method A
Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
Cognitive Behavioral Therapy for Insomnia (CBTI) Plus Taper Method B
Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
|---|---|---|
|
Overall Study
STARTED
|
66
|
66
|
|
Overall Study
COMPLETED
|
63
|
60
|
|
Overall Study
NOT COMPLETED
|
3
|
6
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy for Insomnia (CBTI) Plus Taper Method A
Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
Cognitive Behavioral Therapy for Insomnia (CBTI) Plus Taper Method B
Participants in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBTI) plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
4
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
2
|
Baseline Characteristics
Discontinuation of Hypnotics in Older Veterans
Baseline characteristics by cohort
| Measure |
CBTI Plus Taper Method A
n=66 Participants
Participants in this arm will receive CBTI plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
CBTI Plus Taper Method B
n=66 Participants
Participants in this arm will receive CBTI plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
Total
n=132 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
68.3 years
STANDARD_DEVIATION 8.6 • n=5 Participants
|
70.1 years
STANDARD_DEVIATION 7.7 • n=7 Participants
|
69.2 years
STANDARD_DEVIATION 8.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
54 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
11 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
55 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
116 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
51 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
66 Participants
n=5 Participants
|
66 Participants
n=7 Participants
|
132 Participants
n=5 Participants
|
|
Insomnia Severity Index scale
|
14.1 units on a scale
STANDARD_DEVIATION 6.9 • n=5 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 5.8 • n=7 Participants
|
14.2 units on a scale
STANDARD_DEVIATION 6.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after treatment ends (which is an average of 8 months from randomization)The percentage of participants who had stopped taking a benzodiazepine or z-drug at follow-up. This outcome was measured with 7-day self-reported medication logs.
Outcome measures
| Measure |
CBTI Plus Taper Method A
n=63 Participants
Participants in this arm will receive CBTI plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
CBTI Plus Taper Method B
n=60 Participants
Participants in this arm will receive CBTI plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
|---|---|---|
|
Rates of Hypnotic Discontinuation
|
48 Participants
|
36 Participants
|
PRIMARY outcome
Timeframe: 6 months after treatment ends (which is an average of 8 months from randomization)Mean score on Insomnia Severity Index. This 7-item scale measures self-reported severity of insomnia symptoms. Total score ranges from 0 to 28, with higher scores indicating greater insomnia severity.
Outcome measures
| Measure |
CBTI Plus Taper Method A
n=66 Participants
Participants in this arm will receive CBTI plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
CBTI Plus Taper Method B
n=66 Participants
Participants in this arm will receive CBTI plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
|---|---|---|
|
Insomnia Severity Index Score
|
14.11 score on a scale
Standard Deviation 6.86
|
14.20 score on a scale
Standard Deviation 5.79
|
Adverse Events
CBTI Plus Taper Method A
Serious events: 3 serious events
Other events: 5 other events
Deaths: 1 deaths
CBTI Plus Taper Method B
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CBTI Plus Taper Method A
n=66 participants at risk
Participants in this arm will receive CBTI plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
CBTI Plus Taper Method B
n=66 participants at risk
Participants in this arm will receive CBTI plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Hospitalization for respiratory viral illness
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Infections and infestations
Death from COVID-19
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Gastrointestinal disorders
Small bowel obstruction
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
Other adverse events
| Measure |
CBTI Plus Taper Method A
n=66 participants at risk
Participants in this arm will receive CBTI plus the novel hypnotic tapering method.
CBTI plus taper method A: This intervention includes CBTI plus the novel hypnotic tapering method.
|
CBTI Plus Taper Method B
n=66 participants at risk
Participants in this arm will receive CBTI plus the usual tapering method used by the VA.
CBTI plus taper method B: This intervention includes CBTI plus the usual hypnotic tapering method used by the VA.
|
|---|---|---|
|
Injury, poisoning and procedural complications
Fall
|
3.0%
2/66 • Number of events 2 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Infections and infestations
COVID-19 infection requiring ED visit
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Psychiatric disorders
Hallucinations
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Musculoskeletal and connective tissue disorders
Knee pain with torn meniscus
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Nervous system disorders
parasomnia prior to receiving study medication
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
|
Skin and subcutaneous tissue disorders
Rash
|
1.5%
1/66 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
0.00%
0/66 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
|
Additional Information
Constance H. Fung, MD, MSHS
VA Greater Los Angeles Healthcare System
Phone: 818-891-7711
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place