Problem-Solving Training for Concussion

Brain Concussion Clinical Trial

— PST-Concussion  

Official title:

Problem-Solving Training for Concussion (PST-Concussion): A Brief, Skills-Focused Intervention to Improve Functional Outcomes in Veterans With mTBI and Co-occurring Mental Health Symptoms

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05837676
• Other study ID #: D4778-R
• Secondary ID: RX004778-01
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: September 30, 2027

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Paul R King, PhD
• Phone: (716) 862-6038
• Email: paul.king2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mild traumatic brain injury (mTBI), also known as concussion, is a common injury sustained by Veterans. While most individuals who sustain mTBI experience a complete recovery within several weeks of injury, many Veterans with history of mTBI report frequent and long-lasting neurobehavioral complaints and functional impairment. Though research suggests that these outcomes are strongly influenced by co-occurring conditions such as post-traumatic stress disorder, depression, and chronic pain, evidence-based interventions capable of addressing this wide array of concerns are lacking. This study seeks to address this gap by evaluating the effectiveness of a brief and flexible behavioral health treatment (Problem-Solving Training for Concussion, or PST-Concussion), which was designed to be delivered by generalist providers working in VA primary care settings. If PST-Concussion is shown to be effective, this skills-focused intervention may help improve Veterans' recovery experience following mTBI.

Description:

This study will be a longitudinal randomized two-arm parallel group clinical trial. Participants will be randomized 1:1 to either PST-Concussion or treatment as usual (TAU). Participants assigned to PST-Concussion will receive six, approximately 30-minute telehealth treatment sessions. Assessments will include standard self-report and cognitive measures that will be administered at baseline, post-treatment, and three-month follow-up. The primary objective of this study will be to evaluate the effectiveness of PST-Concussion in reducing psychological distress compared to TAU. Secondary and tertiary objectives will be to evaluate whether PST-Concussion is associated with appreciable change in subjective neurocognitive functioning, objective neurocognitive functioning, psychosocial functioning, and disability and quality of life. Multi-level modeling will be used to evaluate treatment effects at post-treatment and three-month follow-up. A test of non-inferiority will be conducted to evaluate the potential durability of observed treatment effects from post-test to follow-up. A portion of participants assigned to PST-Concussion will also be interviewed at post-treatment or follow-up to gain insight into the practical impact of intervention on psychosocial functioning and quality of life.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 134
• Est. completion date: September 30, 2027
• Est. primary completion date: March 31, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• English-speaking Veteran enrolled in VHA care;
• History of concussion (mild traumatic brain injury or mTBI);
• Current psychological distress;
• Subjective neurocognitive symptoms of >= 3 months.

Exclusion Criteria:

• Moderate to severe TBI or other major neurocognitive disorder;
• Psychotic disorder (e.g., schizophrenia spectrum disorder, delusional disorder, bipolar or depressive disorder with psychotic features);
• Acute suicidal ideation;
• Inpatient psychiatric hospitalization within the past 12 months;
• Other illness/ condition that would preclude or predictably influence ability to engage in study visits, as determined by the study team.

Related Conditions & MeSH terms

• Brain Concussion

Intervention

Behavioral:
• Problem Solving Training for Concussion
PST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.

Other:
• Treatment as usual
Patients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns.

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, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	Alcohol Use Disorders Identification Test (AUDIT)	A 10-item measure of the frequency and severity of alcohol intake over the past year. Scores range from 0-40, with higher scores signaling more severe alcohol-related problems.	Up to 24 weeks
Other	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
Other	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
Other	Community Reintegration of Service-Members (CRIS)	A comprehensive measure of community reintegration validated in Veterans with history of mTBI. It consists of 3 subscales that measure extent of participation, satisfaction with participation, and perceived limitations. Individual items are scored on a scale that ranges from 1 to 7, with higher scores signaling more favorable responses.	Up to 24 weeks
Other	Drug Abuse Screening Test (DAST10)	A 10-item measure of substance misuse and associated functional impairment. Items are rated dichotomously (yes/no), with a total score that ranges from 0 to 10. Higher scores indicate more severe substance use-related problems.	Up to 24 weeks
Other	Behavioral Health Measure-20 (BHM-20)	A brief measure of emotional distress and life functioning, normed for use in primary care. It consists of 3 subscales that measure general well-being, mental health symptoms, and life functioning. Global mental health scale scores range from 0 to 80, with higher scores signaling greater distress and impairment.	Up to 12 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	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	Neurobehavioral Symptom Inventory (NSI)	A 22-item checklist of affective, cognitive, and somatosensory symptoms commonly reported after concussion. Scores range from 0 to 88, with lower scores signaling lower overall symptom reports.	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	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
Secondary	Inventory of Psychosocial Functioning (IPF)	An 80-item multidimensional measure of psychosocial functioning and impairment related to mental health symptoms. An overall total is calculated as the mean of all completed subscales, which include: romantic relationships, family, work, friendships and socializing, parenting, education, and self-care. Each domain scale yields a score ranging from 0-100, with higher scores indicating greater impairment.	Up to 24 weeks