Trial Outcomes & Findings for A Novel Cognitive Remediation Intervention Targeting Poor Decision-making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic (NCT NCT04952532)
NCT ID: NCT04952532
Last Updated: 2026-01-26
Results Overview
The research team will use the Montgomery-Asberg Depression Rating Scale (MADRS) to examine depression symptoms. A higher MADRS score indicates more severe depression and the overall score ranges from 0 to 60. There are 10 items and each item yields a score of 0 to 6. These 10 sub-items are added together for the total score. Typical cutoff points for the total MADRS score are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20-34 - moderate depression \>34 - severe depression Note: The investigators will examine the change in MADRS score from pre-treatment to post-treatment intervention. A positive change score means improvement in depression severity from pre- to post-treatment. The investigators hypothesize that there will be positive change scores following this treatment intervention.
COMPLETED
NA
9 participants
Change in Pre-treatment Score minus Post-treatment Score (Week 10)
2026-01-26
Participant Flow
Participant milestones
| Measure |
Cognitive Remediation+Bridging Intervention
This is a pilot study to collect feasibility data on this novel cognitive remediation intervention for Veterans at high risk for suicide. All patients will receive the active intervention.
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|---|---|
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Overall Study
STARTED
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9
|
|
Overall Study
COMPLETED
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9
|
|
Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Novel Cognitive Remediation Intervention Targeting Poor Decision-making and Depression in Veterans at High Risk for Suicide: A Safe, Telehealth Approach During the COVID-19 Pandemic
Baseline characteristics by cohort
| Measure |
Cognitive Remediation+Bridging Intervention
n=9 Participants
This is a pilot study to collect feasibility data on this novel cognitive remediation intervention for Veterans at high risk for suicide. All patients will receive the active intervention which is: Active NEAR-S+Bridging intervention.
Participants were eligible is they were a US Military Veteran and met DSM-5 criteria for a primary psychiatric diagnosis of major depressive disorder based in the SCID-5. More inclusion/exclusion criteria can be found in Goldstein et al 2025; Military Psychology.
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|---|---|
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Age, Continuous
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50 years
STANDARD_DEVIATION 11.78 • n=25 Participants
|
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Sex: Female, Male
Female
|
0 Participants
n=25 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=25 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=25 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=25 Participants
|
|
Race (NIH/OMB)
White
|
3 Participants
n=25 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=25 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=25 Participants
|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-Tx
|
7.1 Score on a Scale
STANDARD_DEVIATION 12.5 • n=25 Participants
|
PRIMARY outcome
Timeframe: Change in Pre-treatment Score minus Post-treatment Score (Week 10)Population: Change in pre-treatment MADRS score minus post-treatment score (Week 10)
The research team will use the Montgomery-Asberg Depression Rating Scale (MADRS) to examine depression symptoms. A higher MADRS score indicates more severe depression and the overall score ranges from 0 to 60. There are 10 items and each item yields a score of 0 to 6. These 10 sub-items are added together for the total score. Typical cutoff points for the total MADRS score are: 0 to 6 - normal/symptom absent 7 to 19 - mild depression 20-34 - moderate depression \>34 - severe depression Note: The investigators will examine the change in MADRS score from pre-treatment to post-treatment intervention. A positive change score means improvement in depression severity from pre- to post-treatment. The investigators hypothesize that there will be positive change scores following this treatment intervention.
Outcome measures
| Measure |
There is Only One Arm in This Acceptability/Feasibility Study and it is the Active Treatment.
n=9 Participants
Active NEAR-S+Bridging intervention
|
|---|---|
|
Change in Montgomery-Asberg Depression Rating Scale (MADRS) Score: Pre- Minus Post-treatment Intervention
|
7.1 Score on a Scale
Standard Deviation 1.6
|
Adverse Events
Cognitive Remediation+Bridging Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Erin A. Hazlett, PhD, Senior VA Research Career Scientist
James J. Peters VAMC, Bronx, NY, 130 W. Kingsbridge Rd, Bronx, NY 10468
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place