Trial Outcomes & Findings for Enhanced Problem-Solving Training (NCT NCT03759223)
NCT ID: NCT03759223
Last Updated: 2024-08-27
Results Overview
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, sex-matched individuals) with a standard deviation of 10. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
50 participants
Primary outcome timeframe
Up to 24 weeks
Results posted on
2024-08-27
Participant Flow
12 non-randomized (open trial) participants were enrolled to gather feasibility and acceptability data before randomizing 38 participants to E-PST or HLM control.
Participant milestones
| Measure |
E-PST (Randomized)
Enhanced Problem-Solving Training (E-PST) randomized arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training.
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.
|
Control (Randomized)
Healthy Living Messages (Control) randomized arm. Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
Enhanced Problem-Solving Training (E-PST) non-randomized arm. E-PST is a combined treatment that is comprised of brief problem-solving training and compensatory cognitive skills training. Participants in this open label arm provided feasibility and acceptability data on treatment components. Limited clinical data were collected.
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
19
|
19
|
12
|
|
Overall Study
COMPLETED
|
16
|
14
|
7
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Enhanced Problem-Solving Training
Baseline characteristics by cohort
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
Healthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 Participants
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. Non-randomized participants were assigned to E-PST only.
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Age, Continuous
|
42 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
42 years
STANDARD_DEVIATION 7.9 • n=7 Participants
|
41 years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
42 years
STANDARD_DEVIATION 8.2 • n=4 Participants
|
|
Sex/Gender, Customized
Male
|
17 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
|
Sex/Gender, Customized
Prefer Not to Answer
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
46 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
48 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
19 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
50 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to 24 weeksPopulation: All participants
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, sex-matched individuals) with a standard deviation of 10. GSI T-scores range from 30-80, with lower scores signaling an overall lower level of psychological distress.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 Participants
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
Baseline
|
64.21 units on a scale
Standard Error 2.05
|
65.26 units on a scale
Standard Error 2.05
|
66.8 units on a scale
Standard Error 7.9
|
|
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
12 Weeks
|
61.35 units on a scale
Standard Error 2.14
|
61.11 units on a scale
Standard Error 2.17
|
57.0 units on a scale
Standard Error 8.3
|
|
Brief Symptom Inventory-18 (BSI-18) Global Severity Index T-Score
24 Weeks
|
60.85 units on a scale
Standard Error 2.14
|
61.83 units on a scale
Standard Error 2.20
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Applied Cognition-General Concerns-Short Form (ACGC-8a)
Baseline
|
40.44 units on a scale
Standard Error 1.71
|
44.47 units on a scale
Standard Error 1.71
|
—
|
|
Applied Cognition-General Concerns-Short Form (ACGC-8a)
12 Weeks
|
38.94 units on a scale
Standard Error 1.80
|
40.80 units on a scale
Standard Error 1.83
|
—
|
|
Applied Cognition-General Concerns-Short Form (ACGC-8a)
24 Weeks
|
40.66 units on a scale
Standard Error 1.80
|
44.95 units on a scale
Standard Error 1.86
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy individuals) with a standard deviation of 10.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Applied Cognition-Abilities-Short Form (ACA-8a)
Baseline
|
43.16 units on a scale
Standard Error 1.65
|
41.52 units on a scale
Standard Error 1.65
|
—
|
|
Applied Cognition-Abilities-Short Form (ACA-8a)
12 Weeks
|
44.06 units on a scale
Standard Error 1.75
|
42.50 units on a scale
Standard Error 1.78
|
—
|
|
Applied Cognition-Abilities-Short Form (ACA-8a)
24 Weeks
|
44.46 units on a scale
Standard Error 1.74
|
39.00 units on a scale
Standard Error 1.82
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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. The T-score indicates the number of standard deviations away from the mean. A T-score of 50 is equal to the mean of a reference population (i.e., healthy, age-matched individuals) with a standard deviation of 10.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=18 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Hopkins Verbal Learning Test-Revised (HVLT-R)
Baseline- Delayed Recall T-Score
|
34.11 units on a scale
Standard Error 2.66
|
38.12 units on a scale
Standard Error 2.70
|
—
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R)
12 Weeks- Delayed Recall T-Score
|
38.19 units on a scale
Standard Error 2.82
|
35.99 units on a scale
Standard Error 2.88
|
—
|
|
Hopkins Verbal Learning Test-Revised (HVLT-R)
24 Weeks- Delayed Recall T-Score
|
33.88 units on a scale
Standard Error 2.82
|
35.44 units on a scale
Standard Error 2.94
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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 scaled scores (range = 1-19) with corresponding percentile ranks (range = 1 to 99); higher scaled scores and percentile ranks signal better overall performance.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
Baseline
|
7.16 score on a scale
Standard Error 0.35
|
6.95 score on a scale
Standard Error 0.35
|
—
|
|
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
12 Weeks
|
7.47 score on a scale
Standard Error 0.37
|
7.10 score on a scale
Standard Error 0.37
|
—
|
|
Wechsler Adult Intelligence Scale- Fourth Edition (WAIS-IV) Digit Span
24 Weeks
|
7.72 score on a scale
Standard Error 0.37
|
7.06 score on a scale
Standard Error 0.38
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: All participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 Participants
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Patient Health Questionnaire-9 (PHQ-9)
Baseline
|
11.95 units on a scale
Standard Error 1.32
|
11.95 units on a scale
Standard Error 1.32
|
11.7 units on a scale
Standard Error 6.7
|
|
Patient Health Questionnaire-9 (PHQ-9)
12 Weeks
|
10.57 units on a scale
Standard Error 1.38
|
11.07 units on a scale
Standard Error 1.39
|
8.6 units on a scale
Standard Error 6.7
|
|
Patient Health Questionnaire-9 (PHQ-9)
24 Weeks
|
8.82 units on a scale
Standard Error 1.38
|
12.24 units on a scale
Standard Error 1.41
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=18 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=15 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 Participants
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
PTSD Checklist for DSM-5 (PCL5)
Baseline
|
31.15 units on a scale
Standard Error 4.80
|
27.90 units on a scale
Standard Error 5.19
|
40.3 units on a scale
Standard Error 17.9
|
|
PTSD Checklist for DSM-5 (PCL5)
12 Weeks
|
31.04 units on a scale
Standard Error 5.00
|
28.67 units on a scale
Standard Error 5.43
|
35.3 units on a scale
Standard Error 18.9
|
|
PTSD Checklist for DSM-5 (PCL5)
24 Weeks
|
24.52 units on a scale
Standard Error 5.20
|
30.30 units on a scale
Standard Error 5.43
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=17 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
Baseline
|
2.90 units on a scale
Standard Error 0.62
|
4.37 units on a scale
Standard Error 0.61
|
—
|
|
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
12 Weeks
|
2.37 units on a scale
Standard Error 0.63
|
4.21 units on a scale
Standard Error 0.63
|
—
|
|
Alcohol Use Disorders Identification Test-Consumption Questions (AUDIT-C)
24 Weeks
|
1.95 units on a scale
Standard Error 0.63
|
4.00 units on a scale
Standard Error 0.64
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=12 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=15 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Brief Addictions Monitor-Revised (BAM-R)
Baseline
|
2.47 units on a scale
Standard Error 0.65
|
3.02 units on a scale
Standard Error 0.59
|
—
|
|
Brief Addictions Monitor-Revised (BAM-R)
12 Weeks
|
2.69 units on a scale
Standard Error 0.72
|
3.91 units on a scale
Standard Error 0.61
|
—
|
|
Brief Addictions Monitor-Revised (BAM-R)
24 Weeks
|
2.39 units on a scale
Standard Error 0.75
|
3.73 units on a scale
Standard Error 0.65
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Pain Symptom Survey (PEG)
Baseline
|
5.28 units on a scale
Standard Error 0.51
|
5.56 units on a scale
Standard Error 0.51
|
—
|
|
Pain Symptom Survey (PEG)
12 Weeks
|
5.36 units on a scale
Standard Error 0.54
|
4.89 units on a scale
Standard Error 0.55
|
—
|
|
Pain Symptom Survey (PEG)
24 Weeks
|
4.67 units on a scale
Standard Error 0.54
|
4.74 units on a scale
Standard Error 0.56
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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. Because ratings are only collected after receiving a given treatment, baseline values are not collected.
Outcome measures
| Measure |
E-PST (Randomized)
n=16 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=15 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Patient Global Impressions of Change (PGIC)
12 weeks
|
4.19 units on a scale
Standard Error 0.44
|
2.87 units on a scale
Standard Error 0.46
|
—
|
|
Patient Global Impressions of Change (PGIC)
24 weeks
|
4.19 units on a scale
Standard Error 0.47
|
2.92 units on a scale
Standard Error 0.51
|
—
|
SECONDARY outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Baseline- Physical
|
12.66 units on a scale
Standard Error 0.59
|
13.23 units on a scale
Standard Error 0.59
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
12 weeks- Physical
|
12.21 units on a scale
Standard Error 0.62
|
13.40 units on a scale
Standard Error 0.64
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
24 weeks- Physical
|
12.86 units on a scale
Standard Error 0.62
|
12.57 units on a scale
Standard Error 0.65
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Baseline- Psychological
|
13.02 units on a scale
Standard Error 0.71
|
13.05 units on a scale
Standard Error 0.71
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
24 weeks- Environment
|
15.83 units on a scale
Standard Error 0.49
|
16.12 units on a scale
Standard Error 0.51
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
12 weeks- Psychological
|
13.35 units on a scale
Standard Error 0.74
|
12.59 units on a scale
Standard Error 0.75
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
24 weeks- Psychological
|
13.18 units on a scale
Standard Error 0.74
|
11.83 units on a scale
Standard Error 0.76
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Baseline- Social
|
12.63 units on a scale
Standard Error 0.84
|
15.02 units on a scale
Standard Error 0.84
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
12 weeks- Social
|
12.43 units on a scale
Standard Error 0.87
|
14.64 units on a scale
Standard Error 0.88
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
24 weeks- Social
|
13.18 units on a scale
Standard Error 0.87
|
13.98 units on a scale
Standard Error 0.90
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
Baseline- Environment
|
15.82 units on a scale
Standard Error 0.46
|
16.39 units on a scale
Standard Error 0.46
|
—
|
|
World Health Organization Quality of Life - BREF (WHOQOL-BREF)
12 weeks- Environment
|
15.41 units on a scale
Standard Error 0.49
|
16.50 units on a scale
Standard Error 0.50
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Up to 24 weeksPopulation: Randomized participants
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.
Outcome measures
| Measure |
E-PST (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 Participants
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. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 Participants
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Neurobehavioral Symptom Inventory
Baseline
|
42.42 units on a scale
Standard Error 3.59
|
41.42 units on a scale
Standard Error 3.59
|
43.3 units on a scale
Standard Error 17.2
|
|
Neurobehavioral Symptom Inventory
12 weeks
|
40.35 units on a scale
Standard Error 3.70
|
38.02 units on a scale
Standard Error 3.74
|
35.3 units on a scale
Standard Error 17.4
|
|
Neurobehavioral Symptom Inventory
24 weeks
|
37.79 units on a scale
Standard Error 3.70
|
38.81 units on a scale
Standard Error 3.78
|
—
|
Adverse Events
E-PST (Randomized)
Serious events: 1 serious events
Other events: 8 other events
Deaths: 0 deaths
Control (Randomized)
Serious events: 2 serious events
Other events: 6 other events
Deaths: 0 deaths
E-PST (Non-randomized)
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
E-PST (Randomized)
n=19 participants at risk
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 participants at risk
Healthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 participants at risk
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Muscle pain
|
5.3%
1/19 • Number of events 1 • Up to 24 weeks
|
5.3%
1/19 • Number of events 1 • Up to 24 weeks
|
0.00%
0/12 • Up to 24 weeks
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/19 • Up to 24 weeks
|
5.3%
1/19 • Number of events 1 • Up to 24 weeks
|
0.00%
0/12 • Up to 24 weeks
|
Other adverse events
| Measure |
E-PST (Randomized)
n=19 participants at risk
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. Randomized participants were assigned 1:1 to E-PST or HLM.
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.
|
Control (Randomized)
n=19 participants at risk
Healthy Living Messages (Control) arm. Healthy Living Messages (HLM) are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care. Randomized participants were assigned 1:1 to E-PST or HLM.
Healthy Living Messages: Healthy Living Messages are primary care-congruent messages that consist of simple advice regarding general health behaviors and preventive care.
|
E-PST (Non-randomized)
n=12 participants at risk
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. Non-randomized participants were assigned to E-PST only.
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.
|
|---|---|---|---|
|
Psychiatric disorders
Emotional distress, depression
|
31.6%
6/19 • Number of events 6 • Up to 24 weeks
|
31.6%
6/19 • Number of events 7 • Up to 24 weeks
|
0.00%
0/12 • Up to 24 weeks
|
|
Infections and infestations
COVID
|
5.3%
1/19 • Number of events 1 • Up to 24 weeks
|
0.00%
0/19 • Up to 24 weeks
|
0.00%
0/12 • Up to 24 weeks
|
|
Cardiac disorders
Chest pain
|
5.3%
1/19 • Number of events 1 • Up to 24 weeks
|
0.00%
0/19 • Up to 24 weeks
|
0.00%
0/12 • Up to 24 weeks
|
Additional Information
Dr. Paul King, Clinical Research Psychologist
VA Center for Integrated Healthcare
Phone: 716-862-6038
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place