Trial Outcomes & Findings for Window to Hope-Evaluating a Psychological Treatment for Hopelessness Among Veterans With Traumatic Brain Injury (NCT NCT01691378)

NCT ID: NCT01691378

Last Updated: 2019-11-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

44 participants

Primary outcome 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.

Results posted on

2019-11-20

Participant Flow

No significant issues

Participant milestones

Participant milestones
Measure
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.
Waitlist Control
Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment, 3 months after Time 1 baseline.
Overall Study
STARTED
22
22
Overall Study
COMPLETED
15
20
Overall Study
NOT COMPLETED
7
2

Reasons for withdrawal

Reasons for withdrawal
Measure
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.
Waitlist Control
Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment, 3 months after Time 1 baseline.
Overall Study
Withdrawal by Subject
2
0
Overall Study
Lost to Follow-up
5
2

Baseline Characteristics

n=14 WtoH and n=19 Waitlist analyzed at Time 1 baseline due to incomplete BSS data for n=2 participants

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
WtoH Intervention
n=15 Participants
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.
Waitlist Control
n=20 Participants
Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment, 3 months after Time 1 baseline. Waitlist Control arm baseline values reported from the Time 1 assessment
Total
n=35 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Age, Categorical
Between 18 and 65 years
15 Participants
n=15 Participants
20 Participants
n=20 Participants
35 Participants
n=35 Participants
Age, Categorical
>=65 years
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Age, Continuous
47.7 years
STANDARD_DEVIATION 12.1 • n=15 Participants
54.6 years
STANDARD_DEVIATION 8.8 • n=20 Participants
51.6 years
STANDARD_DEVIATION 10.7 • n=35 Participants
Sex: Female, Male
Female
2 Participants
n=15 Participants
1 Participants
n=20 Participants
3 Participants
n=35 Participants
Sex: Female, Male
Male
13 Participants
n=15 Participants
19 Participants
n=20 Participants
32 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
15 Participants
n=15 Participants
20 Participants
n=20 Participants
35 Participants
n=35 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Asian
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
White
11 Participants
n=15 Participants
10 Participants
n=20 Participants
21 Participants
n=35 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=15 Participants
0 Participants
n=20 Participants
0 Participants
n=35 Participants
Race (NIH/OMB)
Unknown or Not Reported
4 Participants
n=15 Participants
10 Participants
n=20 Participants
14 Participants
n=35 Participants
Region of Enrollment
United States
15 Participants
n=15 Participants
20 Participants
n=20 Participants
35 Participants
n=35 Participants
Beck Hopelessness Scale
16.2 units on a scale
STANDARD_DEVIATION 3.2 • n=15 Participants
14 units on a scale
STANDARD_DEVIATION 3.1 • n=20 Participants
14.9 units on a scale
STANDARD_DEVIATION 3.3 • n=35 Participants
Beck Suicide Ideation Scale
5.0 units on a scale
STANDARD_DEVIATION 5.8 • n=14 Participants • n=14 WtoH and n=19 Waitlist analyzed at Time 1 baseline due to incomplete BSS data for n=2 participants
4.8 units on a scale
STANDARD_DEVIATION 5.5 • n=19 Participants • n=14 WtoH and n=19 Waitlist analyzed at Time 1 baseline due to incomplete BSS data for n=2 participants
4.91 units on a scale
STANDARD_DEVIATION 5.6 • n=33 Participants • n=14 WtoH and n=19 Waitlist analyzed at Time 1 baseline due to incomplete BSS data for n=2 participants
Beck Depression Inventory-Second Edition
37.6 units on a scale
STANDARD_DEVIATION 11.6 • n=15 Participants
28.4 units on a scale
STANDARD_DEVIATION 8.4 • n=20 Participants
32.3 units on a scale
STANDARD_DEVIATION 10.8 • n=35 Participants

PRIMARY outcome

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.

Population: 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.

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.

Outcome measures

Outcome measures
Measure
WtoH Intervention
n=15 Participants
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.
Waitlist Control
n=20 Participants
Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment.
Beck Hopelessness Scale (BHS)
Time 2 BHS
9.2 score on a scale
Standard Deviation 5.6
12.6 score on a scale
Standard Deviation 5.2
Beck Hopelessness Scale (BHS)
Time 3 BHS
9.8 score on a scale
Standard Deviation 5.6
8.9 score on a scale
Standard Deviation 6.9

SECONDARY outcome

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.

Population: n=14 WtoH and n=19 Waitlist analyzed at Time 2 assessment due to incomplete BSS data for n=2 participants; n=13 WtoH and n=15 Waitlist BSS analyzed at Time 3 due to loss to follow-up

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

Outcome measures

Outcome measures
Measure
WtoH Intervention
n=15 Participants
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.
Waitlist Control
n=20 Participants
Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment.
Beck Scale for Suicidal Ideation (BSS)
Time 2 BSS
2.0 score on a scale
Standard Deviation 3.9
5.8 score on a scale
Standard Deviation 6.9
Beck Scale for Suicidal Ideation (BSS)
Time 3 BSS
1.9 score on a scale
Standard Deviation 3.7
4.9 score on a scale
Standard Deviation 7.3

SECONDARY outcome

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.

Population: n=14 WtoH and n=16 Waitlist BDI-II analyzed at Time 3 due to loss to follow-up

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

Outcome measures

Outcome measures
Measure
WtoH Intervention
n=15 Participants
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.
Waitlist Control
n=20 Participants
Participants in the Waitlist Control arm continued to receive nonconstrained usual care from the Veterans Health Administration. Waitlist Control arm participants were provided with the opportunity to cross over and receive the WtoH Intervention after Time 2 assessment.
Beck Depression Inventory (BDI -II)
Time 2 BDI-II
26.8 score on a scale
Standard Deviation 12.9
27.0 score on a scale
Standard Deviation 9.4
Beck Depression Inventory (BDI -II)
Time 3 BDI-II
24.9 score on a scale
Standard Deviation 12.8
17.9 score on a scale
Standard Deviation 12.0

Adverse Events

WtoH Intervention

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Waitlist Control

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Lisa Brenner

Rocky Mountain MIRECC

Phone: 720-723-6488

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place