InsomniaCBT-INCT02535923
CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes
A study testing Cognitive Behavioral Therapy-Insomnia and Health and Wellness in people with Insomnia and Psychosis, run by VA Office of Research and Development at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- What is being tested?
- Cognitive Behavioral Therapy-Insomnia and Health and Wellness
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 20 Apr 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
- Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater.
- Age between 18 and 80 as determined by medical record review.
- Participation in outpatient mental health services at a designated study site.
- Sufficient clinical stability to participate as deemed by a treatment provider.
- Capacity to sign Informed Consent.
Who cannot join
- Current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider.
- Currently in CBT-I treatment, determined by medical records.
- Positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, 21201
About this study
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.
Read the 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.
- Being tested
- Cognitive Behavioral Therapy-Insomnia, Health and Wellness
- Keywords
- Schizophrenia and Disorders with Psychotic Feature, Mental Disorders, Insomnia Disorder
- Medical subject headings
- Sleep Initiation and Maintenance Disorders, Psychotic Disorders, Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Therapy-InsomniaBehavioural
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 WellnessBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Experimental | 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. Receives: Behavioral: Cognitive Behavioral Therapy-Insomnia |
| Health and Wellness | Active comparator | 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). Receives: Behavioral: Health and Wellness |
What is being measured
The primary outcome is the main question the study is designed to answer.
Insomnia Severity Index (ISI)
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Secondary outcomes (5)
Insomnia Severity Index (ISI)
ISI score; scored on a scale of 0 to 28, with higher scores indicating worse insomnia severity.
Measured: 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
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.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
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.
Measured: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
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.
Measured: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
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.
Measured: Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2015 (estimated)
- Study start1 Mar 2018
- Primary completion20 Apr 2021
- Study completion20 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for InsomniaStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Collaborators
- VA Maryland Health Care System
- Responsible party
- Sponsor
- Investigators
- Elizabeth A. Klingaman, PhD, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02535923
- Sponsor's protocol ID
- D1836-W
- Other IDs
- 1IK2RX001836-01A1
- Acronym
- CBT-I
- Status last verified
- Feb 2023
- First submitted
- 26 Aug 2015
- Last updated
- 16 Feb 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. doi: 10.2165/00023210-200822110-00004.
PubMed 18840034Bramoweth AD, Germain A. Deployment-related insomnia in military personnel and veterans. Curr Psychiatry Rep. 2013 Oct;15(10):401. doi: 10.1007/s11920-013-0401-4.
PubMed 24005883Klingaman EA, Palmer-Bacon J, Bennett ME, Rowland LM. Sleep Disorders Among People With Schizophrenia: Emerging Research. Curr Psychiatry Rep. 2015 Oct;17(10):79. doi: 10.1007/s11920-015-0616-7.
PubMed 26279058Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.
PubMed 23423416Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.
PubMed 16448292Myers E, Startup H, Freeman D. Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions: a pilot trial. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):330-6. doi: 10.1016/j.jbtep.2011.02.004. Epub 2011 Mar 2.
PubMed 21367359Dopke CA, Lehner RK, Wells AM. Cognitive-behavioral group therapy for insomnia in individuals with serious mental illnesses: a preliminary evaluation. Psychiatr Rehabil J. 2004 Winter;27(3):235-42. doi: 10.2975/27.2004.235.242.
PubMed 14982330
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes
- ClinicalTrials.gov ID
- NCT02535923
- Acronym / sponsor ID
- CBT-I / D1836-W
- Keywords
- Schizophrenia and Disorders with Psychotic Feature, Mental Disorders, Insomnia Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Collaborators
- VA Maryland Health Care System
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 20 Apr 2021 (actual)
- Study completion
- 20 Apr 2021 (actual)
- First posted
- 31 Aug 2015 (estimated)
- Results
- Posted 16 Feb 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Behavioral Therapy-Insomnia | Experimental | Behavioral: Cognitive Behavioral Therapy-InsomniaCBT-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 | Active comparator | Behavioral: Health and WellnessHealth 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). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
- Self-reported symptoms of insomnia via an Insomnia Severity Index (ISI) score of 15 or greater.
- Age between 18 and 80 as determined by medical record review.
- Participation in outpatient mental health services at a designated study site.
- Sufficient clinical stability to participate as deemed by a treatment provider.
Key exclusion criteria (3 listed)
- Current problematic drug or alcohol use that impacts functioning and study engagement, as deemed by a treatment provider.
- Currently in CBT-I treatment, determined by medical records.
- Positive screen for sleep apnea via a portable sleep apnea screening device or a prior diagnosis of sleep apnea in medical records.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive Behavioral Therapy-InsomniaCBT-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. | Behavioural | Cognitive Behavioral Therapy-Insomnia |
| Health and WellnessHealth 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). | Behavioural | Health and Wellness |
Primary outcome
Insomnia Severity Index (ISI)
Time frame: 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.
5 secondary outcomes
Insomnia Severity Index (ISI)
Time frame: 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
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Veterans RAND 36-Item Health Survey Mental Component Score
Time frame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
Time frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
Time frame: Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 18840034Cohrs S. Sleep disturbances in patients with schizophrenia : impact and effect of antipsychotics. CNS Drugs. 2008;22(11):939-62. doi: 10.2165/00023210-200822110-00004.
- Background: PubMed 24005883Bramoweth AD, Germain A. Deployment-related insomnia in military personnel and veterans. Curr Psychiatry Rep. 2013 Oct;15(10):401. doi: 10.1007/s11920-013-0401-4.
- Background: PubMed 26279058Klingaman EA, Palmer-Bacon J, Bennett ME, Rowland LM. Sleep Disorders Among People With Schizophrenia: Emerging Research. Curr Psychiatry Rep. 2015 Oct;17(10):79. doi: 10.1007/s11920-015-0616-7.
- Background: PubMed 23423416Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.
- Background: PubMed 16448292Irwin MR, Cole JC, Nicassio PM. Comparative meta-analysis of behavioral interventions for insomnia and their efficacy in middle-aged adults and in older adults 55+ years of age. Health Psychol. 2006 Jan;25(1):3-14. doi: 10.1037/0278-6133.25.1.3.
- Background: PubMed 21367359Myers E, Startup H, Freeman D. Cognitive behavioural treatment of insomnia in individuals with persistent persecutory delusions: a pilot trial. J Behav Ther Exp Psychiatry. 2011 Sep;42(3):330-6. doi: 10.1016/j.jbtep.2011.02.004. Epub 2011 Mar 2.
- Background: PubMed 14982330Dopke CA, Lehner RK, Wells AM. Cognitive-behavioral group therapy for insomnia in individuals with serious mental illnesses: a preliminary evaluation. Psychiatr Rehabil J. 2004 Winter;27(3):235-42. doi: 10.2975/27.2004.235.242.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elizabeth A. Klingaman, PhD principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Therapy-Insomnia and Health and Wellness in people with Insomnia and Psychosis, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 16 Feb 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insomnia Severity Index (ISI) (time frame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02535923, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.