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
|Condition or disease||Intervention/treatment||Phase|
|Brain Concussion||Behavioral: Enhanced Problem-Solving Training Behavioral: Healthy Living Messages||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|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)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
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
|Contact: Paul R King, PhD||(716) email@example.com|
|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 firstname.lastname@example.org|
|Principal Investigator: Paul R. King, PhD|
|Principal Investigator:||Paul R. King, PhD||VA Western New York Healthcare System, Buffalo, NY|