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NCT03759223 · ClinicalTrials.gov registry record · NA

Enhanced Problem-Solving Training

A NA study, sponsored by VA Office of Research and Development.

Completed
Registry status
NA
Development phase
50
Enrollment target

NCT03759223: Completed NA study, sponsored by VA Office of Research and Development.

NCT03759223 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 50 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03759223, a NA study, has completed, sponsored by VA Office of Research and Development.

COMPLETED
Registry status
NA
Development phase
50 participants
Enrollment target

Study Summary

Mild traumatic brain injury (mTBI) is among the most common injuries sustained by Veterans of Operations Enduring and Iraqi Freedom. It is also highly co-morbid with mental health conditions, such as post-traumatic stress disorder and depression. While mTBI alone is not typically thought to cause lasting deficits in personal functioning or cognitive abilities, Veterans with a history of mTBI nonetheless report chronic psychological distress, as well as subjective difficulties with attention, concentration, poor frustration tolerance, and decision-making. Although current clinical practice guidelines for mTBI emphasize primary care-based symptom management, there are presently no evidence-based interventions to treat mental health symptoms in this setting. This research proposal therefore seeks to adapt and pilot test a brief, primary care-based intervention (E-PST) to reduce psychological distress in Veterans with mTBI by augmenting problem-solving skills, and helping them to develop specific cognitive and behavioral skills to improve upon their self-reported cognitive inefficiencies. The investigators hypothesize that Veterans who complete E-PST will report improvements in psychological distress compared to participants in the control condition.

Primary Outcome

The BSI-18 is a brief measure of psychological distress brought about by common somatic and affective symptoms. It has been validated for use in patients with history of TBI and is appropriate for use in primary care. Similar to a previous trial of PST for mTBI, its Global Severity Index (GSI) T-score will serve as the primary outcome measure. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy,

Interventions

  • BEHAVIORAL Enhanced Problem-Solving Training (E-PST)
  • BEHAVIORAL Healthy Living Messages (HLM)
  • BEHAVIORAL Enhanced Problem-Solving Training (E-PST) (non-randomized)

Trial Details

FieldValue
Enrollment Target 50 participants
Start Date 2019-10-01
Est. Completion 2023-06-07
Phase NA
VA Office of Research and Development

1,668 total trials

What the finished NCT03759223 record still lists

NCT03759223 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (96% lower).

The record links to 0 conditions, and to 3 interventions - of which Enhanced Problem-Solving Training (E-PST) is the first listed.

NCT03759223 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03759223 about?

NCT03759223 is a clinical study titled "Enhanced Problem-Solving Training". Mild traumatic brain injury (mTBI) is among the most common injuries sustained by Veterans of Operations Enduring and Iraqi Freedom. It is also highly co-morbid with mental health conditions, such as post-traumatic stress disorder and depression. While mTBI alone is not typically thought to cause la...

What is the current status of trial NCT03759223?

This trial is currently completed. It is a NA study. The enrollment target is 50 participants. The study started on 2019-10-01. Estimated completion is 2023-06-07.

What interventions are being tested in trial NCT03759223?

The interventions under investigation include: Enhanced Problem-Solving Training (E-PST) (BEHAVIORAL), Healthy Living Messages (HLM) (BEHAVIORAL), Enhanced Problem-Solving Training (E-PST) (non-randomized) (BEHAVIORAL).

Who is sponsoring clinical trial NCT03759223?

This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03759223's enrollment target sits among peer trials

50 1279th of 2000 higher than 622 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03759223, the US trial registry maintained by the National Library of Medicine. NCT03759223 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.