Clinical Trial Details
— Status: Active, not recruiting
Administrative data
| NCT number |
NCT02641496 |
| Other study ID # |
D1799-R |
| Secondary ID |
|
| Status |
Active, not recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 1, 2017 |
| Est. completion date |
June 30, 2023 |
Study information
| Verified date |
December 2022 |
| Source |
VA Office of Research and Development |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Approximately 20 million Americans suffer from Obstructive Sleep Apnea (OSA) creating risks
for major health problems, including dementia, heart attack, and stroke. Obesity, a growing
problem for Americans and Veterans alike, is the greatest risk factor for the development of
OSA. Male gender and smoking, other OSA risk factors, are common in Veterans. Given the high
comorbidity of these risk factors in Veterans, OSA presents a significant health burden to
Veterans. The investigators' prior work provides evidence that OSA occurs in up to 69% of
Vietnam-era Veterans with PTSD. OSA is easily treated; however, 15-30% of OSA patients are
non-compliant with continuous positive airway pressure (CPAP), the standard OSA treatment.
The proposed research aims to facilitate adherence to CPAP treatment by testing a novel
cognitive-behavioral therapy intervention in Veterans with PTSD. If successful, it may
represent an approach that could be applied to the rehabilitation of other chronic conditions
with similar barriers to care.
Description:
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.
*The investigators will add telehealth treatment as an option for participants due to the
COVID-19 pandemic. Research visits may be conducted either in-person or via telehealth (e.g.,
via video or telephone). Telehealth sessions are subject to approval by the research team.
Videoconferencing in particular, requires certain features such as hardware, internet
accessibility, and telephone capability.
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.
