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.
COMPLETED
NA
44 participants
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.
2019-11-20
Participant Flow
No significant issues
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
| 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
| 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
| 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
| 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
| 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
Waitlist Control
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place