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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2012 by VA Eastern Colorado Health Care System.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Military Suicide Research Consortium (MSRC)
Information provided by (Responsible Party):
Lisa Brenner, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier:
NCT01691378
First received: June 5, 2012
Last updated: September 24, 2012
Last verified: September 2012
  Purpose

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 Intervention
Traumatic Brain Injury
Hopelessness
Suicide
Other: Window to Hope
Other: Waitlist Control

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury

Resource links provided by NLM:


Further study details as provided by VA Eastern Colorado Health Care System:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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.


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
    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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: January 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: WtoH Other: Window to Hope
Psychotherapy - Group
Waitlist Control Other: Waitlist Control
Psychotherapy - Group

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 89 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01691378

Contacts
Contact: Lisa A Brenner, Ph.D. 303-399-8020 ext 2571 Lisa.Brenner@va.gov
Contact: Adam Hoffberg 303-399-8020 ext 4645 Adam.Hoffberg@va.gov

Locations
United States, Colorado
VA Eastern Colorado Health Care System Recruiting
Denver, Colorado, United States, 80220
Contact: Lisa A Brenner, Ph.D.    303-399-8020 ext 2571    Lisa.Brenner@va.gov   
Sub-Investigator: Gina M Signoracci, Ph.D.         
Sub-Investigator: Bridget B Matarazzo, Ph.D.         
Sponsors and Collaborators
Lisa Brenner
Military Suicide Research Consortium (MSRC)
Investigators
Principal Investigator: Lisa A Brenner, Ph.D. VA Eastern Colorado Health Care System
  More Information

No publications provided

Responsible Party: Lisa Brenner, Psychologist, MIRECC Director, VA Eastern Colorado Health Care System
ClinicalTrials.gov Identifier: NCT01691378     History of Changes
Other Study ID Numbers: 12-0127
Study First Received: June 5, 2012
Last Updated: September 24, 2012
Health Authority: United States: Federal Government

Keywords provided by VA Eastern Colorado Health Care System:
Veterans
Window to Hope
Cognitive Behavioral Therapy
Traumatic Brain Injury
Hopelessness
Suicide

Additional relevant MeSH terms:
Brain Injuries
Suicide
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Self-Injurious Behavior
Behavioral Symptoms

ClinicalTrials.gov processed this record on September 16, 2014