<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03759223</url>
  </required_header>
  <id_info>
    <org_study_id>D2796-W</org_study_id>
    <secondary_id>RX002796</secondary_id>
    <nct_id>NCT03759223</nct_id>
  </id_info>
  <brief_title>Enhanced Problem-Solving Training</brief_title>
  <acronym>E-PST</acronym>
  <official_title>Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>VA Office of Research and Development</agency>
      <agency_class>U.S. Fed</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>VA Office of Research and Development</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Mild traumatic brain injury (mTBI) is among the most common injuries sustained by Veterans of&#xD;
      Operations Enduring and Iraqi Freedom. It is also highly co-morbid with mental health&#xD;
      conditions, such as post-traumatic stress disorder and depression. While mTBI alone is not&#xD;
      typically thought to cause lasting deficits in personal functioning or cognitive abilities,&#xD;
      Veterans with a history of mTBI nonetheless report chronic psychological distress, as well as&#xD;
      subjective difficulties with attention, concentration, poor frustration tolerance, and&#xD;
      decision-making. Although current clinical practice guidelines for mTBI emphasize primary&#xD;
      care-based symptom management, there are presently no evidence-based interventions to treat&#xD;
      mental health symptoms in this setting. This research proposal therefore seeks to adapt and&#xD;
      pilot test a brief, primary care-based intervention (E-PST) to reduce psychological distress&#xD;
      in Veterans with mTBI by augmenting problem-solving skills, and helping them to develop&#xD;
      specific cognitive and behavioral skills to improve upon their self-reported cognitive&#xD;
      inefficiencies. The investigators hypothesize that Veterans who complete E-PST will report&#xD;
      improvements in psychological distress compared to participants in the control condition.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Open Trial: The primary focus of the open trial is to gather feasibility and acceptability&#xD;
      data from up to 12 participants, though clinical effect will also be evaluated using select&#xD;
      measures outlined below. Feasibility metrics will be internally monitored. Participant&#xD;
      feedback on the acceptability of E-PST will be gathered following each treatment session.&#xD;
      Qualitative data will be analyzed using rapid qualitative analysis. Given the small sample,&#xD;
      clinical effect will be descriptively explored. Individual line graphs of pre-post Brief&#xD;
      Symptom Inventory-18 (BSI-18) scores will be generated, and mean differences in BSI-18 scores&#xD;
      will be compared. Trends in change scores will be visually inspected to evaluate evidence of&#xD;
      a preliminary clinical effect.&#xD;
&#xD;
      Randomized Trial: The focus of the randomized trial is threefold: a) to estimate a&#xD;
      preliminary effect size for the primary outcome measure (BSI-18); b) determine the&#xD;
      feasibility of the assessment plan; and c) establish feasibility of recruitment and retention&#xD;
      in order to guide the design of a future multi-site efficacy trial. BSI-18 data will be&#xD;
      described with means, standard deviations, and confidence intervals at each time point and&#xD;
      condition. To show central tendency, variation and potential trends over time, means and 95%&#xD;
      confidence intervals will be plotted across time for each condition. To assist in developing&#xD;
      a larger trial, an effect size will be calculated at post-treatment to describe the&#xD;
      standardized difference between conditions. All participants who are randomized and complete&#xD;
      a baseline assessment will be included in our analysis. Evaluation of measurement feasibility&#xD;
      will focus primarily on descriptive statistics (e.g., frequencies of missing/ incomplete&#xD;
      measures). Recruitment and retention over the study duration will be plotted based on the&#xD;
      number of participants enrolled into the study and compared to the anticipated rate of&#xD;
      recruitment. Veteran feedback on the acceptability of E-PST and treatment satisfaction will&#xD;
      be analyzed using rapid qualitative analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 1, 2019</start_date>
  <completion_date type="Actual">June 7, 2023</completion_date>
  <primary_completion_date type="Actual">June 7, 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <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.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Applied Cognition-General Concerns-Short Form (ACGC-8a)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Applied Cognition-Abilities-Short Form (ACA-8a)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hopkins Verbal Learning Test-Revised (HVLT-R)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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 = &lt;20 to &gt;80), with higher scores signaling better verbal memory performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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 = &lt;1 to &gt;99); higher ranks signal better overall performance.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Health Questionnaire-9 (PHQ-9)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PTSD Checklist for DSM-5 (PCL5)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Brief Addictions Monitor-Revised (BAM-R)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Symptom Survey (PEG)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient Global Impressions of Change (PGIC)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>A 7-point single-item rating scale that asks patients to rate their overall impression of response to treatment. Ratings range from &quot;no change&quot; to &quot;a great deal better.&quot; Ratings range from 0 to 7, with higher ratings signaling greater perceived change in response to treatment.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>World Health Organization Quality of Life - BREF (WHOQOL-BREF)</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Neurobehavioral Symptom Inventory</measure>
    <time_frame>Up to 24 weeks</time_frame>
    <description>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.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Brain Concussion</condition>
  <arm_group>
    <arm_group_label>E-PST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Enhanced Problem-Solving Training (E-PST)</intervention_name>
    <description>E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training.</description>
    <arm_group_label>E-PST</arm_group_label>
    <other_name>Problem-Solving Training for Concussion (PST-Concussion)</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Healthy Living Messages</intervention_name>
    <description>Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>Control</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  OEF/OIF/OND Veteran&#xD;
&#xD;
          -  history of mild Traumatic Brain Injury and persistent post-concussion-like symptoms of&#xD;
             3 months&#xD;
&#xD;
          -  Brief Symptom Inventory-18 (BSI-18) T-score &gt; 53&#xD;
&#xD;
          -  enrolled in VA primary care (appointment within last 12 months)&#xD;
&#xD;
          -  English speaking, able to read and write, and able to comprehend study materials&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  prior, current, or pending enrollment in a cognitive rehabilitation program or other&#xD;
             specific TBI intervention program&#xD;
&#xD;
          -  moderate to severe TBI or other major neurocognitive disorder&#xD;
&#xD;
          -  psychotic disorder, e.g.: schizophrenia spectrum disorder, delusional disorder,&#xD;
             schizotypal personality disorder, bipolar or depressive disorder with psychotic&#xD;
             features&#xD;
&#xD;
          -  acute suicidal ideation&#xD;
&#xD;
          -  inpatient psychiatric hospitalization within the past 12 months&#xD;
&#xD;
          -  any other illness or condition that would preclude or predictably influence ability to&#xD;
             travel to, or engage in, study visits, as determined by the study team&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Paul R. King, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>VA Western New York Healthcare System, Buffalo, NY</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>VA Western New York Healthcare System, Buffalo, NY</name>
      <address>
        <city>Buffalo</city>
        <state>New York</state>
        <zip>14215-1129</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>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.</citation>
    <PMID>34446984</PMID>
  </reference>
  <reference>
    <citation>King 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.</citation>
    <PMID>36892882</PMID>
  </reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>November 28, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>June 12, 2023</last_update_submitted>
  <last_update_submitted_qc>June 12, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 15, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mild Traumatic Brain Injury</keyword>
  <keyword>Concussion, Mild</keyword>
  <keyword>Veterans</keyword>
  <keyword>Stress Disorders, Post-Traumatic</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Brain Concussion</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_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.</ipd_description>
    <ipd_time_frame>Requests will be considered beginning 6 months after final publication.</ipd_time_frame>
    <ipd_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.</ipd_access_criteria>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03759223
org study id: D2796-W
secondary id: RX002796
nct id: NCT03759223
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
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.
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 select
      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.
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.
primary purpose: Treatment
masking: None (Open Label)
measure: Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
time frame: Up to 24 weeks
description: 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.
measure: Applied Cognition-General Concerns-Short Form (ACGC-8a)
time frame: Up to 24 weeks
description: 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.
measure: Applied Cognition-Abilities-Short Form (ACA-8a)
time frame: Up to 24 weeks
description: 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.
measure: Hopkins Verbal Learning Test-Revised (HVLT-R)
time frame: Up to 24 weeks
description: 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.
measure: Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
time frame: Up to 24 weeks
description: 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.
measure: Patient Health Questionnaire-9 (PHQ-9)
time frame: Up to 24 weeks
description: 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.
measure: PTSD Checklist for DSM-5 (PCL5)
time frame: Up to 24 weeks
description: 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.
measure: Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
time frame: Up to 24 weeks
description: 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.
measure: Brief Addictions Monitor-Revised (BAM-R)
time frame: Up to 24 weeks
description: 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.
measure: Pain Symptom Survey (PEG)
time frame: Up to 24 weeks
description: 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.
measure: Patient Global Impressions of Change (PGIC)
time frame: Up to 24 weeks
description: 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.
measure: World Health Organization Quality of Life - BREF (WHOQOL-BREF)
time frame: Up to 24 weeks
description: 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.
measure: Neurobehavioral Symptom Inventory
time frame: Up to 24 weeks
description: 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.
arm group label: E-PST
arm group type: Experimental
description: 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.
arm group label: Control
arm group type: Active Comparator
description: 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.
intervention type: Behavioral
intervention name: Enhanced Problem-Solving Training (E-PST)
description: E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training.
arm group label: E-PST
other name: Problem-Solving Training for Concussion (PST-Concussion)
intervention type: Behavioral
intervention name: Healthy Living Messages
description: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
arm group label: Control
other name: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Paul R. King, PhD
role: Principal Investigator
affiliation: VA Western New York Healthcare System, Buffalo, NY
facility: 
country: United States
citation: 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: 34446984
citation: King 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: 36892882
responsible party type: Sponsor
mesh term: Brain Concussion
sharing ipd: Yes
ipd 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.
ipd time frame: Requests will be considered beginning 6 months after final publication.
ipd 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.