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

Study Overview
=================
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.

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

Conditions
-----------------
Posttraumatic Stress Disorders, Chronic Insomnia

Intervention / Treatment
-----------------
* Behavioral: CBTI-PE
* Behavioral: Hygiene-PE


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBTI-PE<br>Integrates the core components of CBT-I and PE in 14 90-minute weekly sessions. | Behavioral: CBTI-PE<br>* Integrates CBT-I and PE with the goal of enhancing both insomnia and PTSD outcomes. Integrated treatment will be delivered in 14 90-minute weekly sessions. CBTI-PE starts with VA rollout CBT-I for the first 3 weeks with a focus on the effects of PTSD on insomnia. PE protocol (psychoeducation) begins on week 4 of treatment and both treatments overlap till week 6 when CBT-I ends and the active treatment of PE begins (i.e., imaginal and in-vivo exposures). However, CBT-I sleep diary review and sleep time adjustment will continue till the end of treatment to increase adherence<br>|
| Active Comparator: Hygiene-PE<br>Uses non-active sleep hygiene to account for the dose response of experimental condition before starting PE. Uses 14 90-minute weekly sessions. | Behavioral: Hygiene-PE<br>* The investigators have included a non-active sleep control arm (3 Sessions)to allow for the dose response of 14 90 minute sessions. The non-active sleep control condition used in this study is a manualized protocol developed to exclude the active components of standard CBT-I treatment. Hygiene includes presentation of sleep hygiene education and reviewing daily stressors that may impact sleep before starting PE on week 4.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in PTSD Symptoms | Change in PTSD Symptoms will be assessed using the Clinician-Administered PTSD Scale DSM 5 (CAPS-5) | Baseline, Post Treatment (14-weeks), Follow-up (26-weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Sleep Efficiency | Change in sleep efficiency, calculated as time spent sleeping divided by time spent in bed. This data is acquired from daily sleep logs filled out by patient. | Baseline, Post Treatment (14-weeks), Follow-up (26-weeks) | 
| Change in Quality of Life | Change in Quality of life will be assessed using the World Health Organization Quality of Life-BREF (WHOQOL-BREF) questionnaire. | Baseline, Post Treatment (14-weeks), Follow-up (26-weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PTSD, insomnia, CBT-I, Prolonged Exposure, Veteran