Trial Outcomes & Findings for Sleep Without Insomnia or The Use of Chronic Hypnotics (NCT NCT03687086)

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

188 participants

Primary outcome timeframe

6 months after treatment ends (which is an average of 8 months from randomization)

Results posted on

2024-12-30

Participant Flow

Participant milestones

Participant milestones
Measure	Program A Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Overall Study STARTED	92	96
Overall Study COMPLETED	87	89
Overall Study NOT COMPLETED	5	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Program A Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Overall Study Withdrawal by Subject	3	4
Overall Study Lost to Follow-up	1	1
Overall Study Death	1	0
Overall Study Incomplete assessment	0	2

Baseline Characteristics

Sleep Without Insomnia or The Use of Chronic Hypnotics

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Program A n=92 Participants Cognitive behavioral therapy type A plus medications in packaging type A Program A: Cognitive behavioral therapy type A plus medications prepared in packaging type A.	Program B n=96 Participants Cognitive behavioral therapy type B plus medications in packaging type B Program B: Cognitive behavioral therapy type B plus medications in packaging type B.	Total n=188 Participants Total of all reporting groups
Age, Continuous	69.0 years STANDARD_DEVIATION 8.8 • n=5 Participants	69.4 years STANDARD_DEVIATION 7.8 • n=7 Participants	69.2 years STANDARD_DEVIATION 8.3 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	34 Participants n=7 Participants	65 Participants n=5 Participants
Sex: Female, Male Male	61 Participants n=5 Participants	62 Participants n=7 Participants	123 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants	7 Participants n=7 Participants	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	79 Participants n=5 Participants	89 Participants n=7 Participants	168 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	1 Participants n=5 Participants	5 Participants n=7 Participants	6 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	10 Participants n=5 Participants	7 Participants n=7 Participants	17 Participants n=5 Participants
Race (NIH/OMB) White	72 Participants n=5 Participants	76 Participants n=7 Participants	148 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	8 Participants n=5 Participants	4 Participants n=7 Participants	12 Participants n=5 Participants
Region of Enrollment United States	92 Participants n=5 Participants	96 Participants n=7 Participants	188 Participants n=5 Participants
Insomnia Severity Index	13.8 units on a scale STANDARD_DEVIATION 6.9 • n=5 Participants	14.3 units on a scale STANDARD_DEVIATION 5.7 • n=7 Participants	14.0 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)

Population: For this outcome, the analysis is performed only on those participants who completed the 6-month follow-up assessment and provided data on medication usage. As a result, there were 87 in program A and 89 in program B who met these criteria.

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

Outcome measures
Measure	Program A n=87 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=89 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Rates of Hypnotic Discontinuation	64 Participants	52 Participants

SECONDARY outcome

Timeframe: One week post intervention (which is an average of 9 weeks 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

Outcome measures
Measure	Program A n=92 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=96 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Insomnia Severity Index	7.35 score on a scale Standard Error 0.58	6.47 score on a scale Standard Error 0.57

SECONDARY 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

Outcome measures
Measure	Program A n=92 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=96 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Insomnia Severity Index	7.36 score on a scale Standard Error 0.69	7.71 score on a scale Standard Error 0.68

SECONDARY outcome

Timeframe: One week post intervention (which is an average of 9 weeks from randomization)

These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy). The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.

Outcome measures

Outcome measures
Measure	Program A n=92 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=96 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale	2.38 score on a scale Standard Error 0.25	2.72 score on a scale Standard Error 0.24

SECONDARY outcome

Timeframe: 6 months after treatment ends (which is an average of 8 months from randomization)

These 3-items were used to measure hypnotic expectancies. Items ranged from 0 (strongly disagree/least expectancy) to 10 (strongly agree/most expectancy).The scale score is the average of the 3 items and ranged from 0-10 with higher scores indicating greater hypnotic expectancy. Higher hypnotic expectancies are worse outcomes, lower hypnotic expectancies are better outcomes.

Outcome measures

Outcome measures
Measure	Program A n=92 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=96 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Dysfunctional Beliefs and Attitudes About Sleep - Medication Subscale	3.37 score on a scale Standard Error 0.30	3.33 score on a scale Standard Error 0.30

SECONDARY outcome

Timeframe: One week post intervention (which is an average of 9 weeks from randomization)

Population: For this outcome, the analysis is performed only on those participants who completed the post-intervention assessment and provided data on medication usage. As a result, there were 86 in program A and 92 in program B who met these criteria.

The percentage of participants who had stopped taking a benzodiazepine or z-drug one week after the end of treatment . This outcome was measured with 7-day self-reported medication logs.

Outcome measures

Outcome measures
Measure	Program A n=86 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=92 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Rates of Hypnotic Discontinuation	76 Participants	62 Participants

SECONDARY outcome

Timeframe: One week post intervention (which is an average of 9 weeks from randomization)

The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).

Outcome measures

Outcome measures
Measure	Program A n=92 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=96 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Hypnotic Dose	0.40 diazepam-equivalent milligrams Standard Error 0.16	0.57 diazepam-equivalent milligrams Standard Error 0.16

SECONDARY outcome

Timeframe: 6 months after treatment ends (which is an average of 8 months from randomization)

The mean daily dose based on self-reported 7-day medication log (in diazepam-equivalent milligrams).

Outcome measures

Outcome measures
Measure	Program A n=92 Participants Cognitive Behavioral Therapy for Insomnia, plus novel cognitive and behavioral exercises addressing placebo mechanisms. Medications were prepared in weekly masked blister packs. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.	Program B n=96 Participants Cognitive Behavioral Therapy for Insomnia type B plus medications provided in usual form in a standard medication container. Each participant began the taper with the dose and frequency of the medication that they had been previously prescribed by their provider at the time of the baseline assessment. The taper aimed to reduce the medication by 25% per week over a 9-week period.
Hypnotic Dose	1.05 diazepam-equivalent milligrams Standard Error 0.32	1.32 diazepam-equivalent milligrams Standard Error 0.32

Adverse Events

Program A

Serious events: 4 serious events

Other events: 5 other events

Deaths: 1 deaths

Program B

Serious events: 0 serious events

Other events: 6 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Program A n=92 participants at risk Cognitive behavioral therapy type A plus medications in packaging type A Program A: Cognitive behavioral therapy type A plus medications prepared in packaging type A.	Program B n=96 participants at risk Cognitive behavioral therapy type B plus medications in packaging type B Program B: Cognitive behavioral therapy type B plus medications in packaging type B.
Respiratory, thoracic and mediastinal disorders Hospitalization for respiratory viral illness	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
Infections and infestations Death from COVID-19	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
Gastrointestinal disorders Diverticulitis	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
Gastrointestinal disorders Small bowel obstruction	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).

Other adverse events

Other adverse events
Measure	Program A n=92 participants at risk Cognitive behavioral therapy type A plus medications in packaging type A Program A: Cognitive behavioral therapy type A plus medications prepared in packaging type A.	Program B n=96 participants at risk Cognitive behavioral therapy type B plus medications in packaging type B Program B: Cognitive behavioral therapy type B plus medications in packaging type B.
Injury, poisoning and procedural complications Fall	2.2% 2/92 • Number of events 2 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	1.0% 1/96 • 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 Gout attack requiring ED visit	0.00% 0/92 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	1.0% 1/96 • 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 requiring ED visit	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
Psychiatric disorders Hallucinations	0.00% 0/92 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	1.0% 1/96 • 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% 0/92 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	1.0% 1/96 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).
Cardiac disorders Chest pain	0.00% 0/92 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	1.0% 1/96 • 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	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • 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% 0/92 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	1.0% 1/96 • 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	1.1% 1/92 • Number of events 1 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).	0.00% 0/96 • Adverse events were collected over approximately 8-months (date of randomization until 6-months after treatment).

Additional Information

Dr. Constance Fung

University of California, Los Angeles and 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