Enhanced Problem-Solving Training

Brain Concussion Clinical Trial

— E-PST  

Official title:

Enhanced Problem-Solving Training (E-PST) to Improve Recovery From mTBI

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03759223
• Other study ID #: D2796-W
• Secondary ID: RX002796
• Status: Completed
• Phase: N/A
• Start date: October 1, 2019
• Est. completion date: June 7, 2023

Study information

• Verified date: June 2023
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 7, 2023
• Est. primary completion date: June 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Brain Concussion

Intervention

Behavioral:
• Enhanced Problem-Solving Training (E-PST)
E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training.
• Healthy Living Messages
Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.

Locations

Country	Name	City	State
United States	VA Western New York Healthcare System, Buffalo, NY	Buffalo	New York

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Neurobehavioral Symptom Inventory	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.	Up to 24 weeks
Primary	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. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.	Up to 24 weeks
Secondary	Applied Cognition-General Concerns-Short Form (ACGC-8a)	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.	Up to 24 weeks
Secondary	Applied Cognition-Abilities-Short Form (ACA-8a)	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.	Up to 24 weeks
Secondary	Hopkins Verbal Learning Test-Revised (HVLT-R)	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.	Up to 24 weeks
Secondary	Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span	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.	Up to 24 weeks
Secondary	Patient Health Questionnaire-9 (PHQ-9)	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.	Up to 24 weeks
Secondary	PTSD Checklist for DSM-5 (PCL5)	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.	Up to 24 weeks
Secondary	Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)	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.	Up to 24 weeks
Secondary	Brief Addictions Monitor-Revised (BAM-R)	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.	Up to 24 weeks
Secondary	Pain Symptom Survey (PEG)	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.	Up to 24 weeks
Secondary	Patient Global Impressions of Change (PGIC)	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.	Up to 24 weeks
Secondary	World Health Organization Quality of Life - BREF (WHOQOL-BREF)	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.	Up to 24 weeks