Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

GOALS AND EXPECTED OUTCOMES OF THE PROPOSED RESEARCH The purpose of this proposal is to test
a novel cognitive-behavioral therapy (CBT) intervention to increase continuous positive
airway pressure (CPAP) treatment adherence for PTSD Veterans with a diagnosis of obstructive
sleep apnea (OSA). PTSD is a common, debilitating psychiatric consequence of exposure to
trauma and a source of significant disability among U.S. war Veterans. The largest
epidemiologic study of PTSD in Vietnam Veterans estimates that 15% of Vietnam Veterans suffer
from PTSD [3]. The investigators' research on OSA in Vietnam era Veterans found that 69% of
the Veterans in the sample had an Apnea-Hypopnea Index (AHI) 10 [4]. OSA is likely present in
50% of middle-aged and older VA patients [4, 5]. The recurrent hypoxemia and sleep
fragmentation associated with OSA can lead to neural injury and functional impairment.
Efficacious treatments are available for OSA (e.g., CPAP); however, Veterans with OSA
frequently fail to use them [4, 6, 7], leaving these Veterans at risk for cognitive
dysfunction [8], deterioration of physical health [9], and negative functional outcomes [10].
The investigators' long-term goal is to improve Veterans' functional outcomes by improving
adherence to CPAP. If this intervention proves successful, it may represent an approach that
could be applied to the rehabilitation of other chronic conditions with similar barriers to
care.

RESEARCH DESIGN AND STRATEGY The reasons for low CPAP adherence include barriers related to
discomfort in using CPAP and psychological barriers to behavior change [11]. A CBT treatment
to improve CPAP adherence, CBT-OSA, has been successfully applied in civilian randomized
controlled trials (RCTs) [12, 13]. The proposed VA intervention would involve delivery of
CBT-OSA to PTSD Veterans to foster long-term CPAP adherence. The CBT-OSA treatment would
build on the VISN 21 MIRECC's expertise in CBT interventions [e.g., VA rollout of
CBT-Insomnia] as well as on the investigators' current research on PTSD Veterans with OSA. In
this sample, the vast majority were not diagnosed with OSA prior to study entry; however, 69%
of the participants had an AHI 10 [4]. Of the Veterans previously diagnosed with OSA, 63%
were not using their CPAP. Thus, CPAP adherence treatment for PTSD Veterans is the next
logical step in the investigators' research. Specifically, the investigators propose a 1-year
parallel-group RCT involving 120 PTSD Veterans with a diagnosis of OSA. All participants will
receive treatment as usual in VA Pulmonary Service. Participants in the active arm will
receive CBT-OSA from a trained Clinical Psychologist. The other arm will receive individual
Education based treatment, but not CBT-OSA. Participants in both arms will receive weekly,
individual sessions during the first 4 weeks of CPAP treatment and 4 booster sessions during
the 1-year protocol. These two arms will be referred to hereafter as the CBT-OSA and the
Education groups.

HYPOTHESES Hypothesis 1. (Primary) Effect of CBT on CPAP usage. The investigators hypothesize
that the CBT-OSA group will use CPAP more hours per night on average than the Education
group. ANCOVA will be used to test group differences over time in hours of "mask-on" CPAP
usage per night. [Primary endpoint: mean of Days 335-365.] Hypothesis 2. (Secondary) Effect
of CBT on Self-reported Everyday Activities, Mood and Quality of Life. The investigators
hypothesize that after initiating CPAP treatment, Veterans in the CBT-OSA group will report
more improvement in the ease of performing everyday activities compared to that reported by
those in the Education group. ANCOVA will be used to test group differences over time in the
total score on the Functional Outcomes of Sleep Questionnaire (FOSQ; [14], at Days 0, 21, 365
(endpoint).

Hypothesis 3. (Secondary) Effect of CBT on Cognitive Outcomes. The investigators hypothesize
that the CBT-OSA group will have better cognitive outcomes than the Education group over
time. ANCOVA will be applied to the Rey Auditory Verbal Learning Test, Delayed Recall Score
with the primary endpoint at Day 365.

Hypothesis 4. (Secondary) Effect of CBT on PTSD. The investigators hypothesize that the
CBT-OSA group will have fewer PTSD symptoms than the Education group over time. ANCOVA will
be used to test group differences over time in the total score on the PTSD Checklist for
DSM-5 (PCL-5), measured at Days 0, 21, 365. Primary endpoint is Day 365.

Exploratory and Supplementary Analyses. (Secondary): Individual Differences in Response
(Moderators). Severity of OSA, initial self-efficacy, and other covariates (measured at the
pre-treatment Screening Visit) will be examined in exploratory, hypothesis-generating
analyses to determine "in whom" CBT-OSA works best. Mechanisms of Action (Mediators). Because
CBT-OSA is designed to increase self-efficacy in CPAP adherence, the investigators aim to
show that some of the effect of CBT-OSA on CPAP usage is mediated by change in the self-rated
Self-Efficacy Measure for Sleep Apnea (SEMSA) [15], measured at Days 0, 21, 365.

HOW THE PROPOSED WORK WILL ADDRESS LONGER-TERM GOALS This research fits the VA's goal to
reduce functional disabilities in PTSD Veterans with chronic medical conditions. It is
designed to not only determine the benefit of this intervention overall, but also to
determine in which Veterans CBT-OSA works best. The dataset collected will enable researchers
to troubleshoot the intervention and propose improved interventions.

Inclusion Criteria:

- Male or Female Veterans of any racial or ethnic group

- Age 18 years old and older

- OSA diagnosis by a board-certified Sleep Medicine physician

- Have PTSD

- Capable of giving informed consent for the study; able to read and write English;
willing and able to comply with study requirements and restrictions

- Not have a cognitive disorder

- Sufficient visual and auditory acuity for cognitive testing

- No new medication(s) within the prior 1 month. If on a non-excluded medication for a
non-excluded condition, the medication regimen will be stable (no changes in dose) for
at least 1 month prior to baseline (including anti-hypertensive and diabetic
medications).

Exclusion Criteria:

Sleep

- Current CPAP usage, home oxygen therapy, tracheotomy or past corrective surgery for
OSA (e.g., uvulopalatopharyngo-plasty, midline glossectomy, or lingualplasty).

- Diagnosis of Central Sleep Apnea (CSA)

- Comorbid sleep disorder

- Working night, rotating or split [period of work, followed by break, and then return
to work]; shift work within 1-month of screening or plan to work these shifts during
study; Occupations where participants regularly experience jet lag or have irregular
work schedules.

Other Medical

- Unstable or moderate to severe chronic illness including systolic congestive heart
failure, uncontrolled asthma, severe liver disease, end stage renal disease requiring
hemodialysis or history of systemic illness affecting CNS function (e.g. liver
failure, kidney failure, congestive heart failure, systemic cancer).

- Any current clinically significant cardiovascular, respiratory, neurologic, hepatic,
hematopoietic, renal, gastrointestinal or metabolic dysfunction unless currently
controlled and stable. Any solid organ transplantation.

- Known or suspected neuromuscular disease (e.g. amyotrophic lateral sclerosis, spinal
cord injury)

- History of head injury within past year, or history of loss of consciousness > 24
hours

- History of other neurological disease

- Certain medications

- Judged by the investigators to be unable or unlikely to follow the study protocol.

Psychiatric

- Primary psychotic disorder

- Bipolar disorder

- Prominent suicidal or homicidal ideation

- Current exposure to trauma, or exposure to trauma in the past 3 months

- Some substance use

- Presence of acute or unstable psychiatric condition(s) that requires referral for
treatment.

- Current or expected cognitive behavior therapy for another condition (e.g. insomnia,
anxiety).

Other

- A clinical history or participation in other research that would interfere with the
objectives of this study.

- Any other medical, social, or geographical factor that would make it unlikely that the
participant would comply with the study procedures.