The Assistant Secretary of Defense for Health Affairs, Defense Health Program released a solicitation on July 8th seeking applications for the Psychological Health and Traumatic Brain Injury (PH/TBI) Research Program. For the first time in FY11, the PH/TBI Research Program “Post-Traumatic Stress Disorder In-Home Clinical Trial Award” mechanism is being offered with $5 million available for two awards.
Massive research efforts in PTSD have been launched in recent years to deal with the public health burden of PTSD on individuals, families, communities, and society at large. Many of the treatments use face-to-face in-office treatment modalities with only a handful of alternative treatment delivery modalities such as Tele-Behavioral health utilized.
This funding opportunity is specifically oriented toward evaluating the advantages of an in-home experience from the provider’s perspective which may allow for better insight into a patient’s total life circumstances.
The target population for the study is OIF/OEF veterans who have returned from deployment diagnosed with PTSD. The funding objective is to support randomized controlled trial comparative effectiveness research comparing behavioral healthcare delivered via three distinct treatment modalities:
• Face-to-Face In-Office
• Face-to-Face In-Home
• Tele-Behavioral Health by the provider to the in-home patient
Proposed projects need to include treatment outcome as the metric of primary importance. However, other comparisons and factors of importance include patient compliance, treatment satisfaction, optimizing patient match to treatment modality, ease of treatment delivery, provider/patient safety issues, costs, program management issues, and a “best practice guide to implementation.”
Applications may include a two-tiered approach that would include a limited-scope demonstration trial that transitions into a randomized, controlled, multi-arm research study. A statistical analysis plan is required to include sample size projections to meet the objectives of the study.
The Funding Opportunity Application (W81XWH-11-PHTBI-PTSD-IHT-CTA) is due October 10, 2011 and is available on www.grants.gov. For inquiries, email the CDMRP Help desk at firstname.lastname@example.org.