Telemedicine Management of Veterans with Chronic Insomnia and PTSD

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DESCRIPTION (provided by applicant): Project Background: Most Veterans with PTSD experience chronic insomnia that has independent, negative effects on quality of life and may exacerbate other symptoms of PTSD. Cognitive behavioral therapy for insomnia (CBT-I) is highly efficacious and effective in patients with primary insomnia but the lack of clinicians trained in CBT-I limits Veterans' access to this treatment. Video teleconferencing holds the promise of increasing access to care of Veterans living in rural and remote areas. No previous studies have evaluated the delivery of CBT-I to groups of Veterans with PTSD and chronic insomnia via video teleconferencing. Project Objectives: We will conduct a randomized, controlled trial of Veterans with PTSD and chronic insomnia to compare CBT-I administered by video teleconferencing versus in-person delivery. Aim 1 will determine if CBT-I administered by video teleconferencing is not clinically inferior to in-person treatment in terms of improvement in insomnia symptoms. Aim 2 will compare the differences in cost and quality-adjusted life years between the treatment delivery approaches. Aim 3 will determine the effectiveness of CBT-I on functional outcomes, sleep quality, and non-sleep-related PTSD symptoms. Aim 4 will conduct a patient- and provider- focused formative evaluation of CBT-I delivery by video teleconferencing to assess potential barriers to its widespread implementation. Project Methods: Veterans with PTSD and chronic insomnia receiving their primary care at community-based outpatient clinics (CBOC) affiliated with the Philadelphia VAMC will be randomized to receive one of the following interventions in a group setting at their CBOC: 1) a manual-based CBT-I program delivered via video teleconferencing, 2) the CBT-I program delivered in-person, and 3) in-person delivery of sleep hygiene education, a known active control intervention. Participants will be assessed at baseline, and 2 weeks and every 3 months following the intervention. The primary outcome measure in Aim 1 will be the change in the Insomnia Severity Index (ISI) score at 6 months following intervention. Non-inferiority analysis will be used to compare the effectiveness of the two delivery methods, with a pre-specified margin. Results will be ascertained via intent to treat and per-protocol procedures. We hypothesize that the change in ISI score following CBT-I by video teleconferencing will not be clinically inferior to that following in-person delivery. In Aim 2, VA and non- VA total healthcare costs will be collected to test whether average cost is lower for Veterans receiving CBT-I by video teleconferencing versus in-person care. Preference will be assessed by the EuroQol and Health Utilities Index 2. Differences in the ratio of cost and quality-adjusted life years saved between CBT-I by video teleconferencing and in-person encounter will be compared to test the hypothesis that video teleconferencing will have lower cost and equivalent outcomes. Aim 3 will assess the effect of CBT-I on functional outcomes (Short Form-12, Work and Social Adjustment Scale), sleep quality (Pittsburgh Sleep Quality Index, sleep diary and wrist actigraphy), and PTSD severity (the non-sleep component of the PTSD Checklist-Military). We hypothesize that these functional outcome and sleep quality measures will improve following each method of CBT-I delivery and that CBT-I will improve non-sleep-related PTSD severity. The formative evaluation of the telemedicine delivery of CBT-I in Aim 4 will use qualitative (targeted focus groups with participants and therapist interviews) and quantitative measures (Work Alliance Inventory, Treatment Credibility Scale, attrition) that will help guide future implementation of CBT-I by video teleconferencing. Anticipated Impacts on Veteran's Healthcare: Confirmation of the above hypotheses and the information gained from the formative evaluation will provide the evidence needed to justify clinical implementation of this telemedicine model for CBT-I delivery to Veterans with PTSD. This would significantly increase access to treatment, particularly for Veterans residing in remote and rural settings, and decrease treatment-related costs.