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Enhanced Problem-Solving Training (E-PST)

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ClinicalTrials.gov Identifier: NCT03759223
Recruitment Status : Recruiting
First Posted : November 29, 2018
Last Update Posted : October 3, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Brain Concussion Behavioral: Enhanced Problem-Solving Training Behavioral: Healthy Living Messages Not Applicable

Detailed Description:

Open Trial: The primary focus of the open trial is to gather feasibility and acceptability data from up to 12 participants, though clinical effect will also be evaluated using measures outlined below. Feasibility metrics will be internally monitored. Participant feedback on the acceptability of E-PST will be gathered following each treatment session. Qualitative data will be analyzed using rapid qualitative analysis. Given the small sample, clinical effect will be descriptively explored. Individual line graphs of pre-post Brief Symptom Inventory-18 (BSI-18) scores will be generated, and mean differences in BSI-18 scores will be compared. Trends in change scores will be visually inspected to evaluate evidence of a preliminary clinical effect.

Randomized Trial: The focus of the randomized trial is threefold: a) to estimate a preliminary effect size for the primary outcome measure (BSI-18); b) determine the feasibility of the assessment plan; and c) establish feasibility of recruitment and retention in order to guide the design of a future multi-site efficacy trial. BSI-18 data will be described with means, standard deviations, and confidence intervals at each time point and condition. To show central tendency, variation and potential trends over time, means and 95% confidence intervals will be plotted across time for each condition. To assist in developing a larger trial, an effect size will be calculated at post-treatment to describe the standardized difference between conditions. All participants who are randomized and complete a baseline assessment will be included in our analysis. Evaluation of measurement feasibility will focus primarily on descriptive statistics (e.g., frequencies of missing/ incomplete measures). Recruitment and retention over the study duration will be plotted based on the number of participants enrolled into the study and compared to the anticipated rate of recruitment. Veteran feedback on the acceptability of E-PST and treatment satisfaction will be analyzed using rapid qualitative analysis.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Up to 12 participants will first complete an open trial of E-PST to test the feasibility, acceptability, and preliminary clinical effect. Subsequently, up to 38 participants will be randomly assigned (1:1) to E-PST or a control condition comprised of supportive contact and symptom monitoring.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : April 3, 2023
Estimated Study Completion Date : September 29, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Concussion

Arm Intervention/treatment
Experimental: E-PST
Enhanced 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.
Behavioral: Enhanced Problem-Solving Training
E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training.
Other Name: E-PST

Active Comparator: Control
Healthy Living Messages (Control) arm. Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
Behavioral: Healthy Living Messages
Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
Other Name: Control




Primary Outcome Measures :
  1. Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score [ Time Frame: Up to 24 weeks ]
    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. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.


Secondary Outcome Measures :
  1. Applied Cognition-General Concerns-Short Form (ACGC-8a) [ Time Frame: Up to 24 weeks ]
    An 8-item checklist of general cognitive concerns over the past week. Items were generated and validated as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 23.3-62.7), with higher scores signaling relatively fewer cognitive concerns.

  2. Applied Cognition-Abilities-Short Form (ACA-8a) [ Time Frame: Up to 24 weeks ]
    An 8-item checklist of self-perceived cognitive abilities over the past week, developed as part of the National Institute of Health's Patient-Reported Outcome Measurement Information System (PROMIS). Raw scores are converted to T-scores (range = 27-64.8) with higher scores signaling higher perceived cognitive abilities.

  3. Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Up to 24 weeks ]
    A brief test of verbal learning, recall, and recognition. Participants are read a word list over 3 learning trials, and are asked to recall as many words as possible after a 25-minute delay. Raw scores are converted to T-scores (range = <20 to >80), with higher scores signaling better verbal memory performance.

  4. Trail Making Test A (TMT-A) [ Time Frame: Up to 24 weeks ]
    A timed sequence of tests that requires participants to connect a series of circles in a particular sequence. TMT-A gauges visual attention/ processing speed. Time to completion (seconds) is converted to percentile ranks (range = <1, to >99) that are adjusted for age and educational level; higher ranks signaling better overall performance.

  5. Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span [ Time Frame: Up to 24 weeks ]
    A brief verbal attention test. Participants are presented with a sequence of digits and asked to repeat them forward and backward. Raw scores are converted to percentile ranks (range = <1 to >99); higher ranks signal better overall performance.

  6. Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Up to 24 weeks ]
    A 9-item measure of cognitive, affective, and somatic depressive symptoms validated for use in primary care. Scores range from 0 to 27, with lower scores signaling lower mood symptoms.

  7. PTSD Checklist for DSM-5 (PCL5) [ Time Frame: Up to 24 weeks ]
    A 20-item measure of DSM-5 symptoms related to trauma, organized over re-experiencing, avoidance, hyperarousal, and cognitive/mood domains. Score range from 0-80, with lower scores signaling less severe PTSD symptoms.

  8. Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C) [ Time Frame: Up to 24 weeks ]
    A 3-item measure of the frequency and severity of alcohol intake over the past year. Scores range from 0 to 12, with lower scores signaling less overall alcohol consumption.

  9. Brief Addictions Monitor-Revised (BAM-R) [ Time Frame: Up to 24 weeks ]
    A 17-item measure of substance misuse and associated functional impairment. The Use subscale score ranges from 0-12, with lower scores signaling no (0) or relatively lower substance use.

  10. Pain Symptom Survey (PEG) [ Time Frame: Up to 24 weeks ]
    A 3-item pain assessment that has been validated for use in VA patients. Respondents are asked to report their average level of pain, the average impact of pain on their ability to enjoy life, and the average level of interference on daily activities on a scale of 0 to 10. Ratings on each domain are averaged to calculate a composite score, which ranges from 0 to 10, with lower scores signaling lower overall pain.

  11. Patient Global Impressions of Change (PGIC) [ Time Frame: Up to 24 weeks ]
    A 7-point single-item rating scale that asks patients to rate their overall impression of response to treatment. Ratings range from "no change" to "a great deal better." Ratings range from 0 to 7, with higher ratings signaling greater perceived change in response to treatment.

  12. World Health Organization Quality of Life - BREF (WHOQOL-BREF) [ Time Frame: Up to 24 weeks ]
    A 26-item abbreviated version of the full-length WHOQOL measure that evaluates disability and quality of life in domains such as social relationships, physical and mental health, and satisfaction with person-environment interactions. Raw scores are averaged to compute domain scores (range = 4-20), with higher scores signaling an overall higher quality of life.

  13. Trail Making Test B (TMT-B) [ Time Frame: Up to 24 weeks ]
    A timed sequence of tests that requires participants to connect a series of circles in a particular sequence. TMT-B gauges task-switching ability. Time to completion (seconds) is converted to percentile ranks (range = <1 to >99) that are adjusted for age and educational level; higher ranks signaling better overall performance.


Other Outcome Measures:
  1. Neurobehavioral Symptom Inventory [ Time Frame: Up to 24 weeks ]
    A 22-item checklist of affective, cognitive, and somatosensory symptoms commonly reported after concussion. Scores range from0 to 88, with lower scores signaling lower overall symptom reports.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03759223


Contacts
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Contact: Paul R King, PhD (716) 862-6038 paul.king2@va.gov

Locations
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United States, New York
VA Western New York Healthcare System, Buffalo, NY Recruiting
Buffalo, New York, United States, 14215
Contact: Paul R King, PhD    716-862-6038    paul.king2@va.gov   
Principal Investigator: Paul R. King, PhD         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Paul R. King, PhD VA Western New York Healthcare System, Buffalo, NY

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03759223     History of Changes
Other Study ID Numbers: D2796-W
RX002796 ( Other Grant/Funding Number: VA Rehabilitation Research & Development (RR&D) )
First Posted: November 29, 2018    Key Record Dates
Last Update Posted: October 3, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.
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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Mild Traumatic Brain Injury
Concussion, Mild
Veterans
Stress Disorders, Post-Traumatic
Additional relevant MeSH terms:
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Brain Concussion
Brain Injuries, Traumatic
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Head Injuries, Closed
Wounds and Injuries
Wounds, Nonpenetrating