CBT-I for Psychosis: Guidelines, Preliminary Efficacy, and Functional Outcomes

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.

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.