Trial Outcomes & Findings for Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury (NCT NCT03261674)
NCT ID: NCT03261674
Last Updated: 2024-10-31
Results Overview
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
110 participants
Primary outcome timeframe
Change from baseline at week 8 after treatment
Results posted on
2024-10-31
Participant Flow
Participant milestones
| Measure |
CBTI
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
This therapy addresses thoughts and behaviors that can interfere with sleep. Thoughts and behaviors that develop in response to insomnia can result in heightened anxiety about sleep and the development of coping strategies that can ultimately worsen insomnia. This therapy aims to alter behaviors that contribute to sleep problems, and correct the beliefs that drive those behaviors. Therapy will also include sleep education.
|
ABTI
Arousal-Based Therapy for Insomnia (ABT-I)
During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
This therapy addresses the heightened state of alertness or anxiety that can occur when experiencing difficulty sleeping. This heightened state of arousal develops over time in response to insomnia, and can make falling asleep more difficult. Since this response is learned, it can also be unlearned. This therapy teaches skills to reduce the heightened arousal that contributes to insomnia. Therapy will also include sleep education.
|
|---|---|---|
|
Overall Study
STARTED
|
56
|
54
|
|
Overall Study
COMPLETED
|
47
|
39
|
|
Overall Study
NOT COMPLETED
|
9
|
15
|
Reasons for withdrawal
| Measure |
CBTI
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
This therapy addresses thoughts and behaviors that can interfere with sleep. Thoughts and behaviors that develop in response to insomnia can result in heightened anxiety about sleep and the development of coping strategies that can ultimately worsen insomnia. This therapy aims to alter behaviors that contribute to sleep problems, and correct the beliefs that drive those behaviors. Therapy will also include sleep education.
|
ABTI
Arousal-Based Therapy for Insomnia (ABT-I)
During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
This therapy addresses the heightened state of alertness or anxiety that can occur when experiencing difficulty sleeping. This heightened state of arousal develops over time in response to insomnia, and can make falling asleep more difficult. Since this response is learned, it can also be unlearned. This therapy teaches skills to reduce the heightened arousal that contributes to insomnia. Therapy will also include sleep education.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
6
|
7
|
|
Overall Study
Protocol Violation
|
1
|
4
|
|
Overall Study
Withdrawal by Subject
|
1
|
4
|
|
Overall Study
Physician Decision
|
1
|
0
|
Baseline Characteristics
Non-Pharmacological Treatments for Insomnia in Chronic Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
CBTI
n=56 Participants
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
CBT-I: Cognitive Behavioral Therapy for Insomnia (CBT-I)
|
ABTI
n=54 Participants
Arousal-Based Therapy for Insomnia (ABT-I)
ABT-I: Arousal-Based Therapy for Insomnia (ABT-I)
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
51 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
5 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Age, Continuous
|
49.95 years
STANDARD_DEVIATION 10.32 • n=5 Participants
|
52.56 years
STANDARD_DEVIATION 12.60 • n=7 Participants
|
51 years
STANDARD_DEVIATION 11.52 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
37 Participants
n=7 Participants
|
78 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
49 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
38 Participants
n=7 Participants
|
85 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Change from baseline at week 8 after treatmentPopulation: Of the 110 participants who were randomized, only participants who completed the end of treatment Insomnia Severity Index survey were included in this analysis.
The primary outcome measure is the Veteran's subjective experience of severity of insomnia measured with the Insomnia Severity Index (ISI). The ISI has been shown to be a reliable subjective measure of insomnia severity as well as a sensitive measure of symptom change. This 7-item instrument results in total scores ranging from 0 to 28, with higher scores indicating more severe symptoms. Scores above 15 indicate clinical insomnia, and scores above 22 indicate severe symptoms.
Outcome measures
| Measure |
CBTI
n=47 Participants
Patients in this arm will receive Cognitive Behavioral Therapy for Insomnia (CBT-I)
During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
This therapy addresses thoughts and behaviors that can interfere with sleep. Thoughts and behaviors that develop in response to insomnia can result in heightened anxiety about sleep and the development of coping strategies that can ultimately worsen insomnia. This therapy aims to alter behaviors that contribute to sleep problems, and correct the beliefs that drive those behaviors. Therapy will also include sleep education.
|
ABTI
n=39 Participants
Arousal-Based Therapy for Insomnia (ABT-I)
During the treatment, participants meet with a therapist for a total of six sessions: once per week for six consecutive weeks. Each session lasts approximately 60 minutes.
This therapy addresses the heightened state of alertness or anxiety that can occur when experiencing difficulty sleeping. This heightened state of arousal develops over time in response to insomnia, and can make falling asleep more difficult. Since this response is learned, it can also be unlearned. This therapy teaches skills to reduce the heightened arousal that contributes to insomnia. Therapy will also include sleep education.
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
-9.7 Units on a scale
Standard Deviation 4.42
|
-4.72 Units on a scale
Standard Deviation 4.5
|
Adverse Events
CBTI
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
ABTI
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
Dr Ansgar Furst; Rayma Williams
VA Palo Alto
Phone: (650) 339-4015
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place