Evaluate Novel and Emerging PTSD Treatments

Funding opportunity

Evaluate Novel and Emerging PTSD Treatments

Anticipated timeline and budget

Overview

• The purpose of the interventional study is to perform a pragmatic clinical trial to assess the effectiveness of novel and or emerging PTSD treatments in a cohort of CAF members/Veterans suffering from PTSD.
• Investigators will conduct all aspects of the clinical trial in the setting of a university affiliated treatment facility.
• The results of these clinical studies will have high translational value aimed at improving the effectiveness and efficiency of PTSD treatment over current options, which will optimize clinical management.

Background

Mental disorder is prevalent in both military and veteran populations. Population-based surveys on current serving Canadian Armed Forces members revealed that 16.5% had one or more of 6 past-year disorders assessed, with the most common conditions being major depressive disorder (MDD), posttraumatic stress disorder (PTSD), and generalized anxiety disorder (GAD), which affected 8.0%, 5.3%, and 4.7%, respectively. These prevalences are higher in the veteran population. Moreover, comorbidity of mood and anxiety disorder as well as physical health issues such as chronic pain and mild traumatic brain injury is high in both serving military and veteran populations. Indeed, most cases of PTSD in current serving military members have comorbid mood and anxiety disorders increasing the complexity of treatments.

There are several effective treatments available for PTSD. Current US VA/DoD guidelines primarily endorse trauma focused therapies such as Prolonged Exposure (PE), Cognitive Processing Therapy (CPT) and Eye Movement Desensitization and Reprocessing (EMDR) as well as some pharmacotherapy. Similarly, there are strong evidence-based interventions available to treat MDD.

A major issue limiting the effectiveness of mental disorder treatments in general is the high dropout rates. This is most striking in PTSD treatment. One conservative estimate cited a 24% rate of premature discontinuation in veteran populations, but other estimates have been higher. A recent RAND report examining outcome trajectories in their mental health treatment system concluded that among patients treated for depression, 34% were in a trajectory that showed no improvement over a 6-month period. The result for PTSD treatment were far more concerning where the majority (83%) did not demonstrate improvement of symptoms in six months after initial assessment. It must be emphasized that the latter numbers do not constitute dropout rates but do paint a concerning picture of treatment effectiveness. Among the numerous recommendations of the RAND report was the development and evaluation of more effective mental disorder treatments particularly for PTSD.

Considering this reality, our intent is to facilitate the development, testing and implementation of more effective PTSD treatments that are better tolerated and achieve symptom remission much more quickly than conventional therapies. These would benefit both currently serving military members well as Veterans.

Potential treatment modalities to be studied include but are not limited to medication-assisted psychotherapies, pharmacological interventions targeting novel mechanism of actions and neuromodulation approaches.

Scope and Research objectives

The overarching goal is to test the feasibility of conducting a randomized controlled trial of the novel treatment compared to treatment as usual in a sample of serving CAF members or Veterans with PTSD. This will include:

1. Identifying optimal inclusion and exclusion criteria.
2. Identify effective recruitment strategies.
3. Measure potential adverse outcomes including premature treatment discontinuation.
4. Collect outcomes data to enable sample size calculations for definitive study.

Phases of progress

The project should consist of 3 main phases.

Phases of progress

Phase	Description and schedule for desired outputs
Preparatory	Study protocol and SOPs to be complete by 4 months after initiation of funding agreement.
Application	Feasibility data to be provided within 1.5 years after initiation of funding agreement.
Evaluation	Final reports to be complete within 3 years of initiation of funding agreement.

Preparatory Phase

1. Development of study protocols, including the preparation and submission of research ethics protocols to the participating institutional Research Ethics Boards for approval. Study protocol to be web published
2. Budgeting and purchasing of equipment.
3. Recruitment and training of staff including clinicians, research coordinators, graduate students, and allied study personnel as required.
4. Pilot data collection, following established protocol for a small sample of eligible participants, including clinical assessments.

Application Phase

1. Active recruitment of participants, with double-blind, randomized administration of novel treatment and controlled. NOTE: If double-blind is not possible, then blinded assessment is required.
2. Collection of clinical data before, during and 1 month after treatment completion.
3. Outcomes data must include conventional PTSD measures, as well as clinical tools to measure comorbid conditions and quality of life measures to be used pre and post treatment.
4. Testing of data quality and study compliance at key recruitment phases (10%, 50% and 75% of data collected).

Evaluation Phase

1. Unblinding of participant treatment labels, analysis of treatment effects on clinical measures of primary PTSD outcome measure and quality of life using a potential outcome modelling framework.
2. Analysis of data in support of study outcomes.

Desired outputs

The project’s desired outputs comprise of the following:

• Research ethics board approval from the recipients’ institution.
• Completion of a detailed study protocol to be web published and submitted to the Surgeon General Health Research Board for approval.
• Feasibility data supporting the use of novel treatment as an intervention for PTSD, in the form of summary reports.
• Feasibility study results summarized in a peer-review scientific submission to be shared with sponsor.
• The complete data sets emerging from the study must be made available to the sponsor.
• Language of work is English.

Applicant qualifications and requirements

The successful team will collectively have the following minimum qualifications:

• Senior investigator with an MD or PhD in the field of mental health.
• Access to senior psychiatrist, MD, with knowledge/experience with military mental health concerns and novel treatment modalities. Note this individual can serve as senior investigator.
• An extensive publication history in mental health and PTSD.
• Have access to an onsite treatment facility specializing in the delivery of the novel therapy for PTSD treatment that will be included in the study as well as the ability to deliver conventional PTSD treatment in the control arm.
• The investigator must hold an academic appointment with a recognized Canadian University as well as with a university teaching hospital that delivers both outpatient and inpatient mental health treatments.
• Study site must be geographically located in close proximity to an area in Canada that will facilitate recruitment to either currently serving CAF members or Veterans.
• Investigators will conduct all aspects of the clinical trial in the setting of a university affiliated treatment facility.
• Preference will be given to multicentre collaborative studies if received

Collaborative agreement

The award recipient is expected to work collaboratively with the sponsor (DND) on the analysis and dissemination of results, including scientific publications and presentations.

Intellectual property (IP) ownership

The award recipient will own any foreground IP created by virtue of the funding agreement. The sponsor may request permission to use such intellectual property for their own purposes.

Application deadline

Please download and submit the Research Funding Application form along with timeline to submit applications.

Enquiries

Questions about this funding opportunity can be sent to the VAC Research office.