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Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

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ClinicalTrials.gov Identifier: NCT02641496
Recruitment Status : Recruiting
First Posted : December 29, 2015
Last Update Posted : June 20, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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 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.

Condition or disease Intervention/treatment Phase
Obstructive Sleep Apnea PTSD Posttraumatic Stress Disorder Behavioral: CBT-OSA Behavioral: Sleep Education Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: The Outcomes Assessor will be masked so as to not influence the 12 month outcome variables.
Primary Purpose: Supportive Care
Official Title: Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD
Actual Study Start Date : January 1, 2017
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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

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




Primary Outcome Measures :
  1. Time in hours of "mask-on" CPAP usage per night [ Time Frame: 1 year ]
    The CPAP machine will measure the number of hours that the CPAP mask is on the participant's face and in use.


Secondary Outcome Measures :
  1. Functional Outcomes of Sleep Questionnaire (FOSQ) [ Time Frame: 1 year ]
    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.

  2. California Verbal Learning Test, Second Edition (CVLT-II) [ Time Frame: 1 year ]
    Effect of CBT on Cognitive Outcomes. The CBT-OSA group will have better cognitive outcomes than the Education group over time. The California Verbal Learning Test-II, Delayed Recall Score is the cognitive outcome measure.

  3. PTSD Checklist for DSM-5 (PCL-5) [ Time Frame: 1 year ]
    Effect of CBT on PTSD. The CBT-OSA group will have fewer PTSD symptoms than the Education group over time. The PTSD Checklist for DSM-5 (PCL-5) will be the PTSD outcome measure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02641496


Contacts
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Contact: Lisa M Kinoshita, PhD Lisa.Kinoshita@va.gov
Contact: Kelly Doudell, BS (650) 493-5000 ext 60482 kelly.doudell@va.gov

Locations
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United States, California
VA Palo Alto Health Care System, Palo Alto, CA Recruiting
Palo Alto, California, United States, 94304-1290
Contact: Lisa M Kinoshita, PhD       Lisa.Kinoshita@va.gov   
Contact: Kelly Doudell, BS    (650) 493-5000 ext 60482    kelly.doudell@va.gov   
Principal Investigator: Lisa M. Kinoshita, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Lisa M. Kinoshita, PhD VA Palo Alto Health Care System, Palo Alto, CA

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02641496     History of Changes
Other Study ID Numbers: D1799-R
First Posted: December 29, 2015    Key Record Dates
Last Update Posted: June 20, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Obstructive Sleep Apnea
Sleep Apnea
PTSD
Posttraumatic Stress Disorder
Cognitive Behavioral Therapy
Continuous Positive Airway Pressure
CPAP
Cognition
Memory
Quality of Life
Self Efficacy
CBT
OSA
Education
Psychotherapy
Post Traumatic Stress Disorder
Post-Traumatic Stress Disorder
Therapy
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Apnea
Sleep Disorders, Intrinsic
Sleep Wake Disorders
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Respiration Disorders
Respiratory Tract Diseases
Dyssomnias
Nervous System Diseases
Trauma and Stressor Related Disorders
Mental Disorders