Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

NCT02641496 | Completed Results

• 1 other identifier: D1799-R
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief 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 Posttraumatic Stress Disorder (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.

Conditions

Obstructive Sleep Apnea; PTSD; Posttraumatic Stress Disorder

Keywords

Obstructive Sleep Apnea; PTSD; Posttraumatic Stress Disorder; Cognitive Behavioral Therapy; Continuous Positive Airway Pressure; CPAP; Cognition; Memory; Quality of Life; Self Efficacy; CBT; OSA; Sleep Apnea; Education; Psychotherapy; Post Traumatic Stress Disorder; Post-Traumatic Stress Disorder; Therapy

Outcome Measures

Primary Outcomes (1)

• Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night

  The PAP machine will measure average PAP use in minutes at two timepoints: first 30 days (encompassing the first four weekly treatment sessions) and the last 30 days (final 30 days of the year long study).

  Treatment 1 to Treatment 4 (approximately first 30 days of treatment) and Last 30 Days of 1 Year Study

Secondary Outcomes (3)

• Functional Outcomes of Sleep Questionnaire (FOSQ)

  1 year

• California Verbal Learning Test, Second Edition (CVLT-II)

  1 year

• PTSD Checklist for DSM-5 (PCL-5)

  1 year

Study Arms (2)

CBT-OSA

EXPERIMENTAL

CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.

Behavioral: CBT-OSA

Sleep Education

ACTIVE COMPARATOR

The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.

Behavioral: Sleep Education

Interventions

CBT-OSA BEHAVIORAL

CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.

CBT-OSA

Sleep Education BEHAVIORAL

The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.

Sleep Education

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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 central nervous system (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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Stress Disorders, Post-Traumatic; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Participant recruitment was impacted heavily throughout the study for various reasons. From 2019 until study-end, the study was impacted by the departure of Chief Respiratory Therapist, change in study staff, the COVID-19 pandemic (VA halt of PAP distribution and sleep diagnostic testing from March 2020 to July 2020), Phillips PAP recall, and national shortage of PAPs (significant PAP rationing: PAPs only prescribed to patients at imminent risk of death/hospitalization without PAP therapy).

Results Point of Contact

• Title: Lisa Kinoshita, Ph.D. (Principal Investigator)
• Organization: Veterans Affairs Palo Alto Health Care System

Lisa.Kinoshita@va.gov

650-493-5000

Study Officials

• Lisa M. Kinoshita, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The Outcomes Assessor will be masked so as to not influence the 12 month outcome variables.
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2017
• Primary Completion: September 30, 2022
• Study Completion: December 31, 2023
• Last Updated: July 29, 2024
• Results First Posted: July 29, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)