Clinical trial NCT02774642: Integrated CBT-I and PE on Sleep and PTSD Outcomes (Impact Study)
Official title: The Impact of Integrated CBT-I and PE on Sleep and PTSD Outcomes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Posttraumatic Stress Disorders
Chronic Insomnia
Keywords: PTSD
insomnia
CBT-I
Prolonged Exposure
Veteran
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-05-17
Enrollment: 94
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in PTSD Symptoms
timeFrame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
measure: Change in Sleep Efficiency
timeFrame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
Secondary outcomes:
measure: Change in Quality of Life
timeFrame: Baseline, Post Treatment (14-weeks), Follow-up (26-weeks)
measure: Change in Insomnia Severity
timeFrame: Baseline, week 5, Post Treatment (14-weeks), Follow-up (26-weeks)
Other outcomes:
measure: The Client Satisfaction Questionnaire (CSQ)
timeFrame: Post Treatment ( up to 14-weeks)
measure: Brief Pain Inventory
timeFrame: post treatment, and 3-month follow-ups presented.
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System, San Diego, CA
state: California
Study officials:
affiliation: VA San Diego Healthcare System, San Diego, CA
name: Peter Colvonen, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyons R, Barbir LA, Owens R, Colvonen PJ. STOP-BANG screener vs objective obstructive sleep apnea testing among younger veterans with PTSD and insomnia: STOP-BANG does not sufficiently detect risk. J Clin Sleep Med. 2022 Jan 1;18(1):67-73. doi: 10.5664/jcsm.9498.