Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury (WtoH)
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|ClinicalTrials.gov Identifier: NCT01691378|
Recruitment Status : Active, not recruiting
First Posted : September 24, 2012
Last Update Posted : May 19, 2017
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 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.
|Condition or disease||Intervention/treatment||Phase|
|Traumatic Brain Injury Hopelessness Suicide||Other: Window to Hope Other: Waitlist Control||Not Applicable|
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 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||51 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||October 27, 2015|
|Estimated Study Completion Date :||January 2020|
Other: Window to Hope
Psychotherapy - Group
Other: Waitlist Control
Psychotherapy - Group
- Change in Beck Hopelessness Scale (BHS) [ Time Frame: Change in BHS Score from Time 1 to Time 2 for Treatment Group and Change in BHS Score from Time 2 to Time 3 for Waitlist Control Group ]Time 1 (Baseline for both groups), Time 2 (Post-Intervention for Treatment Group and Baseline 2 for Waitlist Control Group), and Time 3 Assessment (3 month follow up for Intervention Group and Post-Intervention for Waitlist Control Group. The BHS is a 20-item true-false self-report scale that measures the level of negative expectations about the future held by respondents over the previous week. Scores range from 0 to 20 representing nil (0-3), mild (4-8), moderate (9-14), and severe (>14) levels of hopelessness. Beck et al. found that BHS scores equal to or greater than 9 were associated with significantly elevated levels of suicide risk (Beck et al., 1985). As such, to be eligible to participate in this treatment trial individuals must have a score of 9 on the BHS at the time of screening and at the baseline assessment.
- Change in Beck Scale for Suicidal Ideation (BSS) [ Time Frame: Change in BSS Score from Time 1 to Time 2 for Treatment Group and Change in BSS Score from Time 2 to Time 3 for Waitlist Control Group ]The BSS is a 19-item scale that assesses severity of suicide ideation within the previous week with total scores ranging from 0 (no suicide ideation) to 38. High levels of internal consistency (Cronbach's α = .93) and concurrent validity have been reported with the Beck Depression Inventory (r =.64 to r =.75, Beck & Steer, 1993) as well as the BHS in TBI (r =.60, Simpson & Tate, 2002) and non-brain-damaged populations (r =.52 to r = .63, Beck & Steer, 1993).
- Change in Beck Depression Inventory (BDI -II) [ Time Frame: Change in BDI-II Score from Time 1 to Time 2 for Treatment Group and Change in BDI-II Score from Time 2 to Time 3 for Waitlist Control Group ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01691378
|United States, Colorado|
|VA Eastern Colorado Health Care System|
|Denver, Colorado, United States, 80220|
|Principal Investigator:||Lisa A Brenner, Ph.D.||VA Eastern Colorado Health Care System|