Problem-Solving Training for Concussion
ConditionBrain Concussion
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVA Office of Research and Development
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Problem Solving Training for Concussion
BehavioralPST-Concussion is a combined treatment consisting of brief problem-solving training, standard concussion education, motivational interviewing, goal-setting, and compensatory cognitive strategies.
Treatment as usual
Other interventionPatients assigned to TAU will receive the care that they and their providers determine is necessary to best manage their presenting concerns.
Treatment groups
134 Participants
are divided into 2 treatment groupsGroup A: PST-ConcussionExperimental treatment 1 intervention
Group B: Treatment as usual (TAU)Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Up to 24 weeksSecondary outcomes
1
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.
Time frame
Up to 24 weeks2
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.
Time frame
Up to 24 weeks3
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.
Time frame
Up to 24 weeks4
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.
Time frame
Up to 24 weeksOther outcomes
1
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.
Time frame
Up to 24 weeks2
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.
Time frame
Up to 24 weeks3
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.
Time frame
Up to 24 weeks4
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.
Time frame
Up to 24 weeksSponsors and contacts
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Source ClinicalTrials.gov