Clinical trial NCT01691378: Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury
Official title: Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Traumatic Brain Injury
Hopelessness
Suicide
Keywords: Veterans
Window to Hope
Cognitive Behavioral Therapy
Traumatic Brain Injury
Hopelessness
Suicide
Lead sponsor: VA Eastern Colorado Health Care System
Sponsor class: FED
Collaborators: name: Military Suicide Research Consortium
First posted: 2012-09-24
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: After enrollment, participants were randomized to either receive the WtoH Intervention first, or Waitlist Control. After Time 2, the Waitlist Control arm crosses over and has the opportunity to participate in the WtoH Intervention.
Primary purpose: TREATMENT

Brief 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.

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.

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

Primary outcomes:
measure: Beck Hopelessness Scale (BHS)
timeFrame: 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 outcomes:
measure: Beck Scale for Suicidal Ideation (BSS)
timeFrame: 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.
measure: Beck Depression Inventory (BDI -II)
timeFrame: 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.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: VA Eastern Colorado Health Care System
state: Colorado
Study officials:
affiliation: VA Eastern Colorado Health Care System
name: Lisa A Brenner, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Brenner LA, Forster JE, Hoffberg AS, Matarazzo BB, Hostetter TA, Signoracci G, Simpson GK. Window to Hope: A Randomized Controlled Trial of a Psychological Intervention for the Treatment of Hopelessness Among Veterans With Moderate to Severe Traumatic Brain Injury. J Head Trauma Rehabil. 2018 Mar/Apr;33(2):E64-E73. doi: 10.1097/HTR.0000000000000351.
citation: Matarazzo BB, Hoffberg AS, Clemans TA, Signoracci GM, Simpson GK, Brenner LA. Cross-cultural adaptation of the Window to Hope: a psychological intervention to reduce hopelessness among U.S. veterans with traumatic brain injury. Brain Inj. 2014;28(10):1238-47. doi: 10.3109/02699052.2014.916419. Epub 2014 Jun 19.