Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury
Condition: Traumatic Brain Injury; Hopelessness; Suicide
MeSH terms: Brain Injuries; Brain Injuries, Traumatic; Wounds and Injuries; Suicide
Study type: Interventional

Summary: 
      The purpose of this project is to provide further evidence regarding a groundbreaking
      psychological treatment for suicide prevention in individuals with moderate to severe
      traumatic brain injury (TBI), Window to Hope (WtoH). The study will be one of the first five
      randomized clinical trials (RCTs) internationally to evaluate a psychological treatment for
      affective distress after TBI and the first conducted in the United States (U.S.) to
      specifically address suicide risk as an outcome.

      The current project aims to adapt WtoH for U.S. military personnel/Veterans (expert Consensus
      Conference, participant total up to 15), implement the intervention in a Veterans Affairs
      Medical Center (VAMC) (Pilot Groups 1-4, participant total up to 12), and replicate the
      results from the original trial in this novel context with a larger sample size (n=70
      completed protocols [up to 90 recruited]. Deliverables are expected to include an
      intervention suitable for both dissemination and larger Phase III trials.
    

Detailed description: 
      Prior to implementing the intervention, Dr. Simpson will work with VA study team members
      (e.g., Drs. Brenner, Matarazzo, Signoracci) to modify WtoH manual semantics and graphics to
      meet the needs of the U.S. Veteran population. Dr. Brenner has a long history of working
      within the Veterans Health Administration (VHA) and is a Diplomate in Rehabilitation
      Psychology. An expert committee (up to 15 participants) will also be convened for a meeting
      focused on the cross-cultural adaptation of WtoH. All efforts will be made to include experts
      in treating TBI and stakeholders (e.g., Veterans with or without TBI and/or family
      members/support persons) on the committee. Members of the research team will contact
      potential committee members by phone, email, mail or in person. Presentations may also be
      made to Veterans/family members/support persons receiving care, participating in patient
      advocacy activities, or providing peer support. Prior to reviewing the content, the expert
      committee will be provided background on the current state of knowledge about suicidality and
      hopelessness after TBI, available treatment options, and information regarding the underlying
      theoretical basis and key features of the WtoH program. The committee will then review the
      ten sessions to identify potential changes required to the therapeutic content, exercises,
      language and graphics to ensure that it is culturally appropriate for the VAMC context.
      Modifications will be made employing a consensus approach among the expert committee.

      The adapted program will then be trialed across four pilot groups. Once the pilot groups have
      been completed (see below) the expert committee will be reconvened for a final review of the
      program. Data collected on acceptability and feasibility will be presented to the committee
      and test therapists. Any necessary final modifications to assessment procedures and/or the
      intervention to ensure that the program is appropriate for the Veterans' condition will be
      made employing a consensus approach.

      The revised version of the manual will be used to conduct the RCT. Up to 90 Veterans will
      participate.
    

Intervention name(s): Window to Hope; Waitlist Control
Intervention type(s): Other; Other
Intervention description(s): Psychotherapy - Group; Members of the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Those initially allocated to the Waitlist Control arm were later provided with the opportunity to cross over and receive the WtoH Intervention after Time 2.
Allocation: Randomized
Intervention model: Crossover Assignment
Intervention model description: After enrollment, participants were randomized to either receive the WtoH Intervention first, or Waitlist Control. After Time 2, the Waitlist Control arm crosses over and has the opportunity to participate in the WtoH Intervention.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: Veterans; Window to Hope; Cognitive Behavioral Therapy; Traumatic Brain Injury; Hopelessness; Suicide