Enhanced Problem-Solving Training
E-PST
2 other identifiers
interventional
50
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 28, 2018
CompletedFirst Posted
Study publicly available on registry
November 29, 2018
CompletedStudy Start
First participant enrolled
October 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 7, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
June 7, 2023
CompletedResults Posted
Study results publicly available
August 27, 2024
CompletedAugust 27, 2024
August 1, 2024
3.7 years
November 28, 2018
May 10, 2024
August 1, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
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, sex-matched individuals) with a standard deviation of 10. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
Up to 24 weeks
Secondary Outcomes (11)
Applied Cognition-General Concerns-Short Form (ACGC-8a)
Up to 24 weeks
Applied Cognition-Abilities-Short Form (ACA-8a)
Up to 24 weeks
Hopkins Verbal Learning Test-Revised (HVLT-R)
Up to 24 weeks
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
Up to 24 weeks
Patient Health Questionnaire-9 (PHQ-9)
Up to 24 weeks
- +6 more secondary outcomes
Other Outcomes (1)
Neurobehavioral Symptom Inventory
Up to 24 weeks
Study Arms (3)
E-PST (randomized)
EXPERIMENTALEnhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM.
Control (randomized)
ACTIVE COMPARATORHealthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.
E-PST (non-randomized)
OTHEREnhanced Problem-Solving Training (E-PST) arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only.
Interventions
E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.
E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Non-randomized participants were assigned to E-PST only.
Eligibility Criteria
You may qualify if:
- OEF/OIF/OND Veteran
- history of mild Traumatic Brain Injury and persistent post-concussion-like symptoms of 3 months
- Brief Symptom Inventory-18 (BSI-18) T-score \> 53
- enrolled in VA primary care (appointment within last 12 months)
- English speaking, able to read and write, and able to comprehend study materials
You may not qualify if:
- prior, current, or pending enrollment in a cognitive rehabilitation program or other specific TBI intervention program
- moderate to severe TBI or other major neurocognitive disorder
- psychotic disorder, e.g.: schizophrenia spectrum disorder, delusional disorder, schizotypal personality disorder, bipolar or depressive disorder with psychotic features
- acute suicidal ideation
- inpatient psychiatric hospitalization within the past 12 months
- any other illness or condition that would preclude or predictably influence ability to travel to, or engage in, study visits, as determined by the study team
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
VA Western New York Healthcare System, Buffalo, NY
Buffalo, New York, 14215-1129, United States
Related Publications (2)
King PR Jr, Beehler GP, Donnelly K, Funderburk JS, Wray LO. A Practical Guide to Applying the Delphi Technique in Mental Health Treatment Adaptation: The Example of Enhanced Problem-Solving Training (E-PST). Prof Psychol Res Pr. 2021 Aug;52(4):376-386. doi: 10.1037/pro0000371. Epub 2021 Jun 10.
PMID: 34446984BACKGROUNDKing PR, Beehler GP, Donnelly K, Funderburk JS, Pengelly C, Wade M, Kretzmer T, Wray LO. Feasibility and acceptability of a brief intervention to improve mild traumatic brain injury recovery: Problem-solving training-concussion. Rehabil Psychol. 2023 May;68(2):135-145. doi: 10.1037/rep0000486. Epub 2023 Mar 9.
PMID: 36892882BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Limitations and Caveats
This study emphasized feasibility and acceptability metrics. Given the small number of participants enrolled in the randomized pilot trial, there was not sufficient power to robustly detect clinical effects.
Results Point of Contact
- Title
- Dr. Paul King, Clinical Research Psychologist
- Organization
- VA Center for Integrated Healthcare
Study Officials
- PRINCIPAL INVESTIGATOR
Paul R. King, PhD
VA Western New York Healthcare System, Buffalo, NY
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- FED
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 28, 2018
First Posted
November 29, 2018
Study Start
October 1, 2019
Primary Completion
June 7, 2023
Study Completion
June 7, 2023
Last Updated
August 27, 2024
Results First Posted
August 27, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Requests will be considered beginning 6 months after final publication.
- Access Criteria
- Limited datasets in machine-readable electronic format will be created and shared pursuant to a Data Use Agreement (DUA). Appropriate use of the electronic dataset will be specified, as will prohibitions against identifying or re-identifying (i.e., taking steps to identify or re-identify) any individual whose data are included in the dataset.
Final data sets underlying all publications resulting from the proposed research will be shared outside VA. A Limited Dataset (LDS) will be created and shared pursuant to a Data Use Agreement (DUA) appropriately limiting use of the dataset and prohibiting the recipient from identifying or re-identifying (or taking steps to identify or re-identify) any individual whose data are included in the dataset.