Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury (WtoH)

Lisa Brenner

Status: Completed

Conditions: Traumatic Brain Injury; Hopelessness; Suicide

Treatments: Other: Window to Hope; Other: Waitlist Control

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01691378

12-0127

Details and patient eligibility

About

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.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18 to 89 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria for Pilot Groups:

• Age between 18 and 89
• Determination of positive history of moderate/or severe TBI
• Ability to adequately respond to questions regarding the informed consent procedure

Exclusion Criteria for Pilot Groups:

• History of alcohol abuse in the seven days prior to baseline assessment
• History of non-alcohol substance abuse within the last 30 days prior to baseline assessment
• Same-day drug or alcohol abuse during treatment
• History of mild TBI only
• Inability to travel to the Denver VA for daily or weekly therapy sessions

Inclusion Criteria for RCT:

• Age between 18 and 65
• Determination of positive history of moderate/or severe TBI
• Beck Hopelessness Scale score of 9 or greater
• Ability to adequately respond to questions regarding the informed consent procedure

Exclusion Criteria for RCT:

• Diagnosis of neurological condition(s)
• History of alcohol abuse in the seven days prior to baseline assessment
• History of non-alcohol substance abuse within the last 30 days prior to baseline assessment
• Same-day drug or alcohol abuse during treatment
• History of mild TBI only
• Inability to travel to the Denver VA for weekly therapy sessions

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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44 participants in 2 patient groups

WtoH Intervention

Experimental group

Description:

Window to Hope: Psychotherapy consists of 10 2-hour sessions for a maximum dose delivered of 20 hours. Therapy consists of small groups of up to 2 participants.

Treatment:

Other: Window to Hope

Waitlist Control

Other group

Description:

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.

Treatment:

Other: Waitlist Control