Insomnia, Psychosis
Conditions
Keywords
Schizophrenia and Disorders with Psychotic Feature, Mental Disorders, Insomnia Disorder
Brief summary
The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population.
Detailed description
The goal of this project is to develop guidelines for the clinical tailoring of Cognitive Behavioral Therapy for Insomnia (CBT-I) for Veterans with psychotic disorders and insomnia, and to test the acceptability, feasibility, and preliminary efficacy of CBT-I for improving sleep-related functional outcomes in this population. Specific Aim 1: Develop empirically-derived guidelines for the clinical tailoring of CBT-I materials and procedures for Veterans with psychotic disorders through an iterative process with input from Veteran clients, CBT-I experts and providers, as well as those with expertise in psychotic disorders. Specific Aim 2: Establish the acceptability of CBT-I for Veterans with psychotic disorders and insomnia when delivered using guidelines developed in Specific Aim 1 in order to make further refinements to the guidelines in a preliminary trial with 6 Veterans with psychosis and insomnia. Specific Aim 3: Conduct a randomized controlled trial (n=60) to test the feasibility and preliminary efficacy of CBT-I in producing positive changes at post-treatment and 3-month follow-up on the outcomes of insomnia symptoms, sleep quality, and functioning.
Interventions
BEHAVIORALCognitive 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.
BEHAVIORALHealth 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).
Sponsors
VA Maryland Health Care System
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. Diagnostic and Statistical Manual of Disorders, 5th edition (DSM 5) diagnosis of schizophrenic disorders (295.0-295.9), affective psychoses (296.0-296.1, 296.4-296.8), or major depression with psychotic features (296.24, 296.34). 2. Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater. 3. Age between 18 and 80 as determined by medical record review. 4. Participation in outpatient mental health services at a designated study site. 5. Sufficient clinical stability to participate as deemed by a treatment provider. 6. Capacity to sign Informed Consent.
Exclusion criteria
1. Current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider. 2. Currently in CBT-I treatment, determined by medical records. 3. Positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insomnia Severity Index (ISI) | 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. |
| Veterans RAND 36-Item Health Survey Mental Component Score | 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. |
| World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 26 |
| 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). | 21 |
| Total | 47 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 5 | 5 |
| Overall Study | Withdrawal by Subject | 4 | 3 |
Baseline characteristics
| Characteristic | Cognitive Behavioral Therapy-Insomnia | Health and Wellness | Total |
|---|---|---|---|
| Age, Continuous | 52.8 years STANDARD_DEVIATION 10.6 | 50.4 years STANDARD_DEVIATION 12.6 | 51.8 years STANDARD_DEVIATION 11.5 |
| Insomnia Severity Index | 18.7 units on a scale STANDARD_DEVIATION 5.1 | 18.1 units on a scale STANDARD_DEVIATION 5.6 | 18.5 units on a scale STANDARD_DEVIATION 5.3 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 8 Participants | 11 Participants | 19 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 3 Participants | 4 Participants | 7 Participants |
| Race (NIH/OMB) White | 15 Participants | 6 Participants | 21 Participants |
| Sex: Female, Male Female | 7 Participants | 4 Participants | 11 Participants |
| Sex: Female, Male Male | 19 Participants | 17 Participants | 36 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 2 / 26 | 0 / 21 |
| other Total, other adverse events | 1 / 26 | 0 / 21 |
| serious Total, serious adverse events | 0 / 26 | 0 / 21 |
Outcome results
Primary
Insomnia Severity Index (ISI)
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Insomnia Severity Index (ISI) | 11.6 units on a scale | Standard Deviation 7.5 |
| Health and Wellness | Insomnia Severity Index (ISI) | 15.2 units on a scale | Standard Deviation 4.5 |
p-value: 0.04Mixed Models Analysis
p-value: 0.83Mixed Models Analysis
Secondary
Insomnia Severity Index (ISI)
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Insomnia Severity Index (ISI) | 12.4 units on a scale | Standard Deviation 7.4 |
| Health and Wellness | Insomnia Severity Index (ISI) | 13.0 units on a scale | Standard Deviation 6 |
p-value: 0.83Mixed Models Analysis
Secondary
Veterans RAND 36-Item Health Survey Mental Component Score
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.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Veterans RAND 36-Item Health Survey Mental Component Score | 40.0 units on a scale | Standard Deviation 13.8 |
| Health and Wellness | Veterans RAND 36-Item Health Survey Mental Component Score | 45.5 units on a scale | Standard Deviation 10.8 |
p-value: 0.003Mixed Models Analysis
Secondary
Veterans RAND 36-Item Health Survey Mental Component Score
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.
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Veterans RAND 36-Item Health Survey Mental Component Score | 48.4 units on a scale | Standard Deviation 12.2 |
| Health and Wellness | Veterans RAND 36-Item Health Survey Mental Component Score | 47.8 units on a scale | Standard Deviation 12.6 |
p-value: 0.16Mixed Models Analysis
Secondary
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | 39.9 units on a scale | Standard Deviation 22.3 |
| Health and Wellness | World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | 34.1 units on a scale | Standard Deviation 25.8 |
p-value: 0.82Mixed Models Analysis
Secondary
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
WHO-DAS score; scores range from 0 to 100 where 100 is full disability.
Time frame: Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | 42.9 units on a scale | Standard Deviation 22.7 |
| Health and Wellness | World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale | 29.6 units on a scale | Standard Deviation 15.6 |