Trial Outcomes & Findings for CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes (NCT NCT02535923)
NCT ID: NCT02535923
Last Updated: 2023-02-16
Results Overview
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
47 participants
Primary outcome timeframe
Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Results posted on
2023-02-16
Participant Flow
Participant milestones
| Measure |
Cognitive Behavioral Therapy-Insomnia
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Overall Study
STARTED
|
26
|
21
|
|
Overall Study
Completed Post Assessment
|
22
|
17
|
|
Overall Study
Completed Follow Up Assessment
|
17
|
13
|
|
Overall Study
COMPLETED
|
17
|
13
|
|
Overall Study
NOT COMPLETED
|
9
|
8
|
Reasons for withdrawal
| Measure |
Cognitive Behavioral Therapy-Insomnia
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
5
|
5
|
|
Overall Study
Withdrawal by Subject
|
4
|
3
|
Baseline Characteristics
CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes
Baseline characteristics by cohort
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=26 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=21 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
Total
n=47 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.8 years
STANDARD_DEVIATION 10.6 • n=5 Participants
|
50.4 years
STANDARD_DEVIATION 12.6 • n=7 Participants
|
51.8 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
19 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 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
|
8 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Insomnia Severity Index
|
18.7 units on a scale
STANDARD_DEVIATION 5.1 • n=5 Participants
|
18.1 units on a scale
STANDARD_DEVIATION 5.6 • n=7 Participants
|
18.5 units on a scale
STANDARD_DEVIATION 5.3 • n=5 Participants
|
PRIMARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=22 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=17 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
11.6 units on a scale
Standard Deviation 7.5
|
15.2 units on a scale
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=17 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=13 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Insomnia Severity Index (ISI)
|
12.4 units on a scale
Standard Deviation 7.4
|
13.0 units on a scale
Standard Deviation 6.0
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.Veterans RAND 36-Item Health Survey score Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental quality of life.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=22 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=17 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Veterans RAND 36-Item Health Survey Mental Component Score
|
40.0 units on a scale
Standard Deviation 13.8
|
45.5 units on a scale
Standard Deviation 10.8
|
SECONDARY outcome
Timeframe: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.Veterans RAND 36-Item Health Survey Mental Component Score; Possible scores range from 0 to 100, with higher scores indicating greater mental health quality of life.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=17 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=13 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Veterans RAND 36-Item Health Survey Mental Component Score
|
48.4 units on a scale
Standard Deviation 12.2
|
47.8 units on a scale
Standard Deviation 12.6
|
SECONDARY outcome
Timeframe: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=22 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=17 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
|
39.9 units on a scale
Standard Deviation 22.3
|
34.1 units on a scale
Standard Deviation 25.8
|
SECONDARY outcome
Timeframe: Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Outcome measures
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=17 Participants
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=13 Participants
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
|
42.9 units on a scale
Standard Deviation 22.7
|
29.6 units on a scale
Standard Deviation 15.6
|
Adverse Events
Cognitive Behavioral Therapy-Insomnia
Serious events: 0 serious events
Other events: 1 other events
Deaths: 2 deaths
Health and Wellness
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Cognitive Behavioral Therapy-Insomnia
n=26 participants at risk
Cognitive Behavioral Therapy-Insomnia: CBT-I addresses cognitive, arousal and behavioral factors related to sleep difficulties. Sessions combine assessment, conceptualization, psychoeducation, behavioral strategies and cognitive therapy, using a consistent structure including review of participants' sleep log and adherence to behavioral guidelines, modification of time in bed, cognitive therapy, and relaxation techniques. CBT-I also incorporates psychoeducation about biological and psychological elements that regulate sleep. Other strategies include stimulus control (i.e., getting out of bed when not sleepy) to extinguish the conditioned arousal common in insomnia, and relaxation techniques to reduce arousal associated with the bed, bedroom, or bedtime.
|
Health and Wellness
n=21 participants at risk
Health and Wellness: Health and Wellness is a general self-management curriculum focused on providing education and support for managing physical and emotional well-being. Each session follows a basic structure including review of previous session material, new educational information and discussion on several topics over the course of single or multiple sessions. Each session will focus on the impact of the topic on overall health and wellness, identifying benefits and challenges to improving or maintaining health in that area, and strategies that clients may find helpful to address challenges in that area. Example topics include physical activity/exercise, nutrition/healthy eating, managing medications and side effects, and addictive behaviors (e.g., substance use, gambling, eating).
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
3.8%
1/26 • Number of events 1 • From baseline to an average of 22 weeks per participant.
|
0.00%
0/21 • From baseline to an average of 22 weeks per participant.
|
Additional Information
Elizabeth A Klingaman PhD
Department of Veterans Affairs
Phone: 410-259-7810
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place