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

October 30, 2019 updated by: Lisa Brenner

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • VA Eastern Colorado Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 89 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: WtoH Intervention
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.
Other: Window to Hope
Psychotherapy - Group
Other: Waitlist Control
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.
Other: Waitlist Control
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Hopelessness Scale (BHS)
Time Frame: Time 2 BHS was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BHS was assessed 6 months after Time 1 baseline for both arms of the trial.
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 Time 1 baseline assessment. BHS outcome administered at the following study timepoints: Time 1 (Baseline for both arms), Time 2 (Post-Intervention for WtoH Intervention arm and Baseline 2 for Waitlist Control arm), and Time 3 Assessment (3 month follow up for WtoH Intervention arm and Post-Intervention for Waitlist Control arm.
Time 2 BHS was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BHS was assessed 6 months after Time 1 baseline for both arms of the trial.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Beck Scale for Suicidal Ideation (BSS)
Time Frame: Time 2 BSS was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BSS was assessed 6 months after Time 1 baseline for both arms of the trial.
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 Traumatic Brain Injury (TBI) (r =.60, Simpson & Tate, 2002) and non-brain-damaged populations (r =.52 to r = .63, Beck & Steer, 1993). BSS outcome administered at the following study timepoints: Time 1 (Baseline for both arms), Time 2 (Post-Intervention for WtoH Intervention arm and Baseline 2 for Waitlist Control arm), and Time 3 Assessment (3 month follow up for WtoH Intervention arm and Post-Intervention for Waitlist Control arm
Time 2 BSS was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BSS was assessed 6 months after Time 1 baseline for both arms of the trial.
Beck Depression Inventory (BDI -II)
Time Frame: Time 2 BDI-II was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BDI-II was assessed 6 months after Time 1 baseline for both arms of the trial.
The Beck Depression Inventory-Second Edition (BDI-II) is a self-report instrument measuring the severity of common depressive symptoms. Each of its 21 items is rated on a 4-point Likert scale ranging from 0 to 3; total scores range from 0 to 63, with higher scores indicating greater degrees of depressive symptomatology. High levels of internal consistency (Cronbach α = 0.93) have been reported as well as concurrent validity with the BDI (r = 0.64 to r = 0.75), and the BHS among those with TBI (r = 0.60) (Beck and Steer, 1998) and general population samples (r = 0.52 to r = 0.63). (Beck and Steer, 1993). BDI-II outcome administered at the following study timepoints: Time 1 (Baseline for both arms), Time 2 (Post-Intervention for WtoH Intervention arm and Baseline 2 for Waitlist Control arm), and Time 3 Assessment (3 month follow up for WtoH Intervention arm and Post-Intervention for Waitlist Control arm
Time 2 BDI-II was assessed 3-months after Time 1 baseline assessment for both arms of the trial. Time 3 BDI-II was assessed 6 months after Time 1 baseline for both arms of the trial.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Brenner

Collaborators

Military Suicide Research Consortium

Investigators

  • Principal Investigator: Lisa A Brenner, Ph.D., VA Eastern Colorado Health Care System

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

October 27, 2015

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

June 5, 2012

First Submitted That Met QC Criteria

September 19, 2012

First Posted (Estimate)

September 24, 2012

Study Record Updates

Last Update Posted (Actual)

November 20, 2019

Last Update Submitted That Met QC Criteria

October 30, 2019

Last Verified

October 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-0127

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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