CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Window to Hope +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01691378
NCT01691378N/ACompleted

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

Lisa Brenner·interventional·Posted Sep 24, 2012·Updated Nov 20, 2019

In Brief

A clinical study evaluating Window to Hope and Waitlist Control for Traumatic Brain Injury and 2 related conditions. Completed, enrolled 44 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedSep 24, 2012
Enrollment StartJan 1, 2012
Primary CompletionOct 27, 2015
Study CompletionSep 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 13.8 years ago

Interventions

Window to Hopeother

Psychotherapy - Group

Waitlist Controlother

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.