Trial Outcomes & Findings for Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD (NCT NCT02641496)

Last Updated: 2024-07-29

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

76 participants

Primary outcome timeframe

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

Results posted on

2024-07-29

Participant Flow

133 participants were recruited and screened; 76 met screening requirements, had a working PAP, and completed at least one treatment. 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 diagnostics from March 2020 to July 2020), national shortage of PAP devices resulting in PAP rationing, and Phillips PAP recall.

Participant milestones

Participant milestones
Measure	CBT-OSA CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a positive airway pressure (PAP) machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Overall Study STARTED	41	35
Overall Study COMPLETED	27	23
Overall Study NOT COMPLETED	14	12

Reasons for withdrawal

Reasons for withdrawal
Measure	CBT-OSA CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a positive airway pressure (PAP) machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Overall Study Lost to Follow-up	13	12
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Cognitive Behavioral Therapy to Increase CPAP Adherence in Veterans With PTSD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CBT-OSA n=41 Participants CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a positive airway pressure (PAP) machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education n=35 Participants The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.	Total n=76 Participants Total of all reporting groups
Age, Continuous	57.24 years STANDARD_DEVIATION 14.9 • n=5 Participants	56.77 years STANDARD_DEVIATION 12.11 • n=7 Participants	57.03 years STANDARD_DEVIATION 13.6 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	37 Participants n=5 Participants	32 Participants n=7 Participants	69 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	9 Participants n=7 Participants	18 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	31 Participants n=5 Participants	25 Participants n=7 Participants	56 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) White	24 Participants n=5 Participants	20 Participants n=7 Participants	44 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	4 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Region of Enrollment United States	41 Participants n=5 Participants	35 Participants n=7 Participants	76 Participants n=5 Participants

PRIMARY outcome

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

Population: Of the 50 participants who completed the study, a certain number were missing data for each outcome measure. Only complete data-points were used in the resulting analyses, such that the overall n for mask-on time reflects the total number of participants who had complete data for this particular variable (n=49).

Outcome measures

Outcome measures
Measure	CBT-OSA n=26 Participants CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education n=23 Participants The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night Average PAP Use for First 30 Days	234.00 minutes per night Standard Deviation 140.01	144.25 minutes per night Standard Deviation 159.97
Time in Minutes of "mask-on" Positive Airway Pressure (PAP) Machine Usage Per Night Average PAP Use for Last 30 Days	157.04 minutes per night Standard Deviation 161.82	152.39 minutes per night Standard Deviation 157.36

SECONDARY outcome

Timeframe: 1 year

Population: Of the 50 participants who completed the study, a certain number were missing data for each outcome measure. Only complete data-points were used in the resulting analyses, such that the resulting n for FOSQ reflects the total of participants who had complete data for this particular variable (n=40).

Effect of CBT on Self-reported Everyday Activities, Mood and Quality of Life. Functional Outcomes of Sleep Questionnaire (FOSQ) total scores range from 5 to 20. Lower values indicate higher functioning across different functional areas (e.g., less interference of fatigue on work functioning or on relationships). 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.

Outcome measures

Outcome measures
Measure	CBT-OSA n=22 Participants CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education n=18 Participants The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Functional Outcomes of Sleep Questionnaire (FOSQ)	15.77 score on a scale Standard Deviation 4.03	15.10 score on a scale Standard Deviation 3.31

SECONDARY outcome

Timeframe: 1 year

Population: Of the 50 participants who completed the study, a certain number were missing data for each outcome measure. Only complete data-points were used in the resulting analyses, such that the resulting n for CVLT-II Long Delay reflects the total of participants who had complete data for this particular variable (n=45).

Effect of CBT on Cognitive Outcomes. California Verbal Learning Test-II Long Delay Free Recall (CVLT-II LD FC) scores range from 0 to 16. Higher raw scores indicate more items retained and better memory performance. The investigators hypothesize that after initiating CPAP treatment, 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.

Outcome measures

Outcome measures
Measure	CBT-OSA n=24 Participants CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education n=21 Participants The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
California Verbal Learning Test, Second Edition (CVLT-II)	9.00 raw score Standard Deviation 3.16	8.48 raw score Standard Deviation 3.36

SECONDARY outcome

Timeframe: 1 year

Population: Of the 50 participants who completed the study, a certain number were missing data for each outcome measure. Only complete data-points were used in the resulting analyses, such that the resulting n for PCL-5 reflects the total of participants who had complete data for this particular variable (n=48).

Effect of CBT on PTSD. PTSD Checklist for DSM-5 (PCL-5) total scores range from 0 to 80. For the PCL-5, higher values indicate higher levels of current PTSD symptoms, thus a higher level of current PTSD severity. The investigators hypothesize that after initiating CPAP treatment, 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.

Outcome measures

Outcome measures
Measure	CBT-OSA n=26 Participants CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine. CBT-OSA: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a PAP machine.	Sleep Education n=22 Participants The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
PTSD Checklist for DSM-5 (PCL-5)	27.31 score on a scale Standard Deviation 18.31	26.82 score on a scale Standard Deviation 17.39

Adverse Events

CBT-OSA

Serious events: 1 serious events

Other events: 5 other events

Deaths: 2 deaths

Sleep Education

Serious events: 1 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	CBT-OSA n=41 participants at risk 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: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.	Sleep Education n=35 participants at risk The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Renal and urinary disorders Renal Infarct	0.00% 0/41 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.	2.9% 1/35 • Number of events 1 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.
Nervous system disorders Cerebrovascular Accident	2.4% 1/41 • Number of events 1 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.	0.00% 0/35 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.

Other adverse events

Other adverse events
Measure	CBT-OSA n=41 participants at risk 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: CBT-OSA is a new cognitive behavioral therapy which focuses on changing behaviors and thoughts to help individuals adjust to using a CPAP machine.	Sleep Education n=35 participants at risk The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene. Sleep Education: The Sleep Education treatment will include information, facts, and videos on sleep, cardiovascular disease, PTSD, and proper sleep hygiene.
Injury, poisoning and procedural complications Fracture	0.00% 0/41 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.	2.9% 1/35 • Number of events 2 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.
Surgical and medical procedures Surgery	9.8% 4/41 • Number of events 4 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.	0.00% 0/35 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.
Social circumstances Psychological Distress	2.4% 1/41 • Number of events 1 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.	0.00% 0/35 • Adverse Events and Serious Adverse Events were collected from the time of study entry until end of study participation for each participant, spanning approximately 12 months.

Additional Information

Lisa Kinoshita, Ph.D. (Principal Investigator)

Veterans Affairs Palo Alto Health Care System

Phone: 650-493-5000

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place