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

NCT01691378 | Completed Results

• 1 other identifier: 12-0127
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Hopelessness; Suicide

Keywords

Veterans; Window to Hope; Cognitive Behavioral Therapy; Traumatic Brain Injury; Hopelessness; Suicide

Outcome Measures

Primary Outcomes (1)

• Beck Hopelessness Scale (BHS)

  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 Outcomes (2)

• Beck Scale for Suicidal Ideation (BSS)

  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 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.

Study Arms (2)

WtoH Intervention

EXPERIMENTAL

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

Waitlist Control

OTHER

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

Interventions

Window to Hope OTHER

Psychotherapy - Group

WtoH Intervention

Waitlist Control OTHER

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.

Waitlist Control

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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
• 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

Sponsors & Collaborators

• Lisa Brenner: lead
• Military Suicide Research Consortium: collaborator

Study Sites (1)

VA Eastern Colorado Health Care System

Aurora, Colorado, 80045, United States

Location

Related Publications (2)

• 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.

  PMID: 29084101 BACKGROUND

• 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.

  PMID: 24946053 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic; Suicide

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Self-Injurious Behavior; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Lisa Brenner
• Organization: Rocky Mountain MIRECC

lisa.brenner@va.gov

720-723-6488

Study Officials

• Lisa A Brenner, Ph.D.

  VA Eastern Colorado Health Care System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: FED
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Psychologist, MIRECC Director

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2012
• First Posted: September 24, 2012
• Study Start: January 1, 2012
• Primary Completion: October 27, 2015
• Study Completion: September 1, 2018
• Last Updated: November 20, 2019
• Results First Posted: November 20, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)