Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)



Status:Recruiting
Conditions:Insomnia Sleep Studies, Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:19 - Any
Updated:11/30/2018
Start Date:October 1, 2016
End Date:September 30, 2021
Contact:Peter Colvonen, PhD
Email:peter.colvonen@va.gov

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The Impact of Integrated CBT-I and PE on Sleep and PTSD Outcomes

This study aims to examine whether integrating insomnia and PTSD treatment will enhance
sleep, PTSD, and quality of life outcomes. This is a randomized control trial comparing
integrated evidence based CBT-I into PE (CBTI-PE) versus to a non-active sleep component plus
PE (hygiene-PE) to optimize PTSD, sleep, and quality of life outcomes in 90 Veterans. Such
benefits would further the VA's commitment to improving the mental health, recovery, and
community reintegration of Veterans detailed in the 2014-2020 VHA Strategic Plan. Findings
from the proposed study offer a unique opportunity to determine the malleability of
mechanisms (e.g., Total sleep time, Sleep efficiency) that can improve recovery outcomes
among this vulnerable population and to inform future treatment development and research.
Improved PTSD, insomnia, and quality of life outcomes can decrease risk of chronic impairment
and ultimately help affected Veterans live richer, more productive lives.

The lifetime prevalence of posttraumatic stress disorder (PTSD) is approximately 30% among
Vietnam Veterans and 11-17% among Iraq and Afghanistan Veterans. PTSD is associated with
enormous health care costs, increased suicidality, depression, poorer quality of life and
functioning, physical health, and increased substance use. Prolonged exposure (PE) is an
efficacious treatment for Veterans with PTSD that decreases avoidance of feared, but safe,
cues. Despite PE being one of the best available treatments for PTSD, 25 to 45% of PTSD
patients still meet diagnostic criteria following treatment. High rates of comorbid
disorders, such as insomnia, may interfere with the efficacy of PE and limit long-term
rehabilitation outcomes.

Among Veterans with PTSD, sleep disturbances are nearly universal with 70 - 87% reporting
comorbid insomnia. Untreated insomnia can persist for years, is independently associated with
impaired health-related quality of life, does not resolve following PTSD treatment, and can
exacerbate daytime PTSD symptoms.

Importantly, insomnia may interfere with the mechanisms of PE through safety learning,
habituation to feared stimuli, emotional coping, emotional processing, and cognitive
abilities necessary for successful treatment.

Despite this, insomnia is not a primary intervention for Veterans with PTSD. Given these
factors, it is critical to evaluate whether treating insomnia prior to PTSD will improve PTSD
symptoms and quality of life outcomes. Cognitive behavioral treatment for insomnia (CBT-I) is
the first line treatment of chronic and severe insomnia, which produces lasting improvements
in sleep. By using CBT-I prior to, and integrated with, PE offers several novel advantages
that will: 1) increase client-centered treatment by addressing the number one subjective
complaint among Veterans with PTSD; 2) enhance PTSD outcomes and non-response rates by
addressing insomnia-related factors that interfere with PTSD treatment; 3) act as a stepping
stone and help to engage patients who are not initially willing to engage in trauma-focused
PE; 4) increase rehabilitation outcomes by addressing the two leading disorders that
independently affect quality of life for Veterans; 5) allow patients to address both symptoms
of insomnia and PTSD within a shortened timeframe; 6) increase continuity by allowing
patients to work with a single provider; and 7) decrease the risk of attrition between
referral clinics and waitlists. To date, no studies have capitalized on available
evidence-based CBT-I prior to PE to improve insomnia, PTSD, and quality of life outcomes.

Inclusion Criteria:

- Over the age of 19 years old

- Diagnosis of PTSD

- Meet diagnostic criteria for insomnia

- Enrolled at the VA San Diego Healthcare System (VASDHS) and living within 50 miles of
the respective facility

- English literacy

Exclusion Criteria:

- Unmanaged psychosis or manic episodes in past year

- Substance/alcohol use disorder in past 6 months

- Diagnosed (previously or by the investigators' study screen) and untreated sleep
disorder other than insomnia

- Sleep disorders diagnosed, but stably treated, such as obstructive sleep apnea
treated with continuous positive airway pressure (CPAP), will be allowed)

- Participation in concurrent psychotherapies targeting PTSD

- Veteran can be reassessed after their PTSD treatment concludes

- Veterans who are engaged in treatment for non-PTSD symptoms (e.g., 12-step
programs) will be eligible

- Severe medical or psychiatric illness that would make it difficult to regularly attend
psychotherapy sessions or participate fully in the study

- History of moderate to severe cognitive impairment
We found this trial at
1
site
San Diego, California 92161
Principal Investigator: Peter Colvonen, PhD
Phone: 858-642-3657
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mi
from
San Diego, CA
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