Clinical trial NCT02535923: CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes
Official title: CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Insomnia
Psychosis
Keywords: Schizophrenia and Disorders with Psychotic Feature
Mental Disorders
Insomnia Disorder
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
Collaborators: name: VA Maryland Health Care System
First posted: 2015-08-31
Enrollment: 47
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
Secondary outcomes:
measure: Insomnia Severity Index (ISI)
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
measure: Veterans RAND 36-Item Health Survey Mental Component Score
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
measure: Veterans RAND 36-Item Health Survey Mental Component Score
timeFrame: Participants will be assessed a second time following completion of the study intervention, an expected average of 22 weeks.
measure: World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
timeFrame: Participants will be assessed following completion of the study intervention, an expected average of 10 weeks.
measure: World Health Organization Disability Assessment Schedule (WHO-DAS), Participation in Society Subscale
timeFrame: Participants will be assessed a second time following completion of study intervention, an estimated average of 22 weeks.
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Elizabeth A. Klingaman, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Bramoweth 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.
citation: Klingaman 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.
citation: Buysse DJ. Insomnia. JAMA. 2013 Feb 20;309(7):706-16. doi: 10.1001/jama.2013.193.
citation: Irwin 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.
citation: Myers 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.
citation: Dopke 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.