N/A
N=44
Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury
Traumatic Brain Injury · Hopelessness · Suicide
Bottom Line
View on ClinicalTrials.gov: NCT01691378 ↗Enrolled (actual)
44
Serious AEs
0.0%
Results posted
Nov 2019
Primary outcome: Primary: Beck Hopelessness Scale (BHS) — 9.2; 12.6; 9.8; 8.9 score on a scale — p=.03
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Window to Hope (Other); Waitlist Control (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Lisa Brenner
- Primary completion
- Oct 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Beck Hopelessness Scale (BHS) |
9.2; 12.6; 9.8; 8.9 | .03 sig |
| SECONDARY Beck Scale for Suicidal Ideation (BSS) |
2.0; 5.8; 1.9; 4.9 | .07 |
| SECONDARY Beck Depression Inventory (BDI -II) |
26.8; 27.0; 24.9; 17.9 | .13 |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01691378). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.