Traumatic Brain InjuryWtoHNCT01691378

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

A study testing Window to Hope in people with Traumatic Brain Injury and Hopelessness, run by Lisa Brenner at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 89 years
Conditions the study is for: Traumatic Brain Injury, Hopelessness, Suicide
What is being tested?: Window to Hope
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 44 participants
Where: 1 siteUnited States
Study dates: Jan 2012to 1 Sep 2018
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 89 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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
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

Who cannot join

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
Diagnosis of neurological condition(s)

Show all 11Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

VA Eastern Colorado Health Care System
Aurora, Colorado, 80045

Other trials in United States

About this study

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.

Read the 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.

Conditions: Traumatic Brain Injury, Hopelessness, Suicide
Being tested: Window to Hope, Waitlist Control
Keywords: Veterans, Window to Hope, Cognitive Behavioral Therapy, Traumatic Brain Injury, Hopelessness, Suicide
Medical subject headings: Brain Injuries, Traumatic, Suicide

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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.

Study groups in NCT01691378
Study group	Role	What they receive
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. Receives: 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. Receives: Other: Waitlist Control

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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)
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
Measured: 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)
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
Measured: 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.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 20121 Sep 2018

First posted24 Sep 2012 (estimated)
Study startJan 2012
Primary completion27 Oct 2015
Study completion1 Sep 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
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.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 44 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01691378
Sponsor's protocol ID: 12-0127
Acronym: WtoH
Status last verified: Oct 2019
First submitted: 5 Jun 2012
Last updated: 20 Nov 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 29084101
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.
PubMed 24946053

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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All Traumatic Brain Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury
ClinicalTrials.gov ID: NCT01691378
Acronym / sponsor ID: WtoH / 12-0127
Conditions: Traumatic Brain Injury, Hopelessness, Suicide
Keywords: Veterans, Window to Hope, Cognitive Behavioral Therapy, Traumatic Brain Injury, Hopelessness, Suicide
Study type: Interventional
Recruitment status: Completed
Enrolment: 44 participants (actual)
Lead sponsor: Lisa BrennerUS federal agency
Collaborators: Military Suicide Research Consortium
Study start: Jan 2012
Primary completion: 27 Oct 2015 (actual)
Study completion: 1 Sep 2018 (actual)
First posted: 24 Sep 2012 (estimated)
Results: Posted 20 Nov 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The revised version of the manual will be used to conduct the RCT. Up to 90 Veterans will participate.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 2
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.

Arm	Type	Receives
WtoH Intervention	Experimental	Other: Window to HopeWindow 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.
Waitlist Control	Other	Other: Waitlist ControlMembers 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.

Who may qualify

Ages: 18 to 89 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

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
Age between 18 and 65
Determination of positive history of moderate/or severe TBI

Key exclusion criteria (11 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Window to HopePsychotherapy - Group	Other	WtoH Intervention
Waitlist ControlMembers 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

Primary outcome

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.

2 secondary outcomes

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.
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.

Results and safety

Results posted to the registry on 20 Nov 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
WtoH Intervention	22	15
Waitlist Control	22	20

Primary outcome: 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.. Mean (Standard Deviation). Unit: score on a scale

Measure	WtoH Intervention n = 15	Waitlist Control n = 20
Time 2 BHS	9.2 (5.6)	12.6 (5.2)
Time 3 BHS	9.8 (5.6)	8.9 (6.9)

WtoH Intervention vs Waitlist Control: Mean Difference (Final Values): 4.4 (95% CI .52 to 8.3), p = .03, ANCOVA
Waitlist Control: Mean Difference (Final Values): -4.6 (95% CI -7.9 to -1.3), p = .01, Regression, Linear
WtoH Intervention: Mean Difference (Final Values): -6.3 (95% CI -9.3 to -3.2), p = .0007, one-sample t-test

Population analysed: Participants were included in the outcome analysis if they completed the Time 2 assessment. N=14 participants from the WtoH Intervention first arm and n=16 participants from the Waitlist Control arm were analyzed at Time 3 due to loss to follow-up.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
WtoH Intervention	0 of 15 (0%)	0 of 15 (0%)	Not reported
Waitlist Control	0 of 20 (0%)	0 of 20 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 29084101Brenner 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.
Background: PubMed 24946053Matarazzo 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.
Individual participant dataSharing planned: No

Related trials for Traumatic Brain Injury

Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
Enrolling by invitationPhase 1
Pilot Safety and Exploratory Efficacy of PSC-05 for the Treatment of Chronic Mild Traumatic Brain Injury
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RecruitingObservational study
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Lisa A Brenner, Ph.D. principal investigator

VA Eastern Colorado Health Care System

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Window to Hope in people with Traumatic Brain Injury and Hopelessness, run by Lisa Brenner at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01691378, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Nov 2019.