Posttraumatic Stress Disorder, Depression, Alcohol-Related Disorders, Suicidal Ideation, Substance-Related Disorders, Mild Cognitive Impairment, Quality of Life, Pain, Wounds and Injury, Brain Injuries, Chronic Disease
Conditions
Brief summary
The overarching goal of this UH2-UH3 proposal is to work with the NIH Health Care Systems Research Collaboratory to develop and implement a large scale, cluster randomized pragmatic clinical trial demonstration project that directly informs national trauma care system policy targeting injured patients with presentations of Posttraumatic Stress Disorder (PTSD) and related comorbidity. Each year in the United States (US), over 30 million individuals present to trauma centers, emergency departments, and other acute care medical settings for the treatment of physical injuries. Multiple chronic conditions including enduring PTSD, alcohol and drug use problems, depression and associated suicidal ideation, pain and somatic symptom amplification, and chronic medical conditions (e.g., hypertension, coronary artery disease, diabetes, and pulmonary diseases) are endemic among physical trauma survivors with and without traumatic brain injuries (TBI). Evidence-based, collaborative care/care management treatment models for PTSD and related comorbidities exist. These care management models have the potential to be flexibly implemented in order to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both TBI and non-TBI injuries; care management models may also be effective in mitigating the impact of the acute injury event on symptom exacerbations in the large subpopulation of injury survivors who already carry a substantial pre-injury burden of multiple chronic medical conditions.
Detailed description
Primary Aims and Hypotheses The primary aim of the UH3 period is to conduct a pragmatic randomized effectiveness trial of a collaborative care intervention targeting PTSD and comorbid conditions after acute care injury hospitalization. The investigation aims to determine if injured patients receiving the collaborative care intervention demonstrate significant reductions in PTSD symptoms when compared to control patients receiving care as usual. The study also aims to determine if the intervention patients when compared to control patients will demonstrate significant reductions in depressive symptoms, suicidal ideation, and alcohol use problems, and improvements in physical function. The primary hypothesis is that the intervention group when compared to the control group will demonstrate significant reductions in PTSD symptoms over the course of the year after injury. Secondary hypotheses are that intervention patients when compared to control patients will demonstrate, significant reductions in depressive symptoms, significant reductions in alcohol use problems, and improved post-injury physical function. A Priori Secondary Analyses The study team hypothesizes that a subgroup of patients will have persistent PTSD symptoms that will not remit over the longitudinal course of the investigation, regardless of randomization to intervention or control group conditions. The study team also anticipates that readily identifiable baseline clinical, injury and demographic characteristics will be associated with persistent PTSD symptoms over time (e.g., higher PTSD symptom levels, greater pre-injury trauma exposure, intentional injury including firearm related injury mechanisms and other characteristics such as unemployment, as well as other baseline factors). Derived from previous randomized clinical trials, a cumulative burden index has been developed from these baseline characteristics and will be adapted for the current investigation. The study team proposes a series of secondary analyses that adjust for and stratify by baseline characteristics that put patients at risk for persistent symptoms. It is hypothesized that these secondary analyses will identify a subgroup of intervention patients who are not at risk for persistent symptoms and who will demonstrate clinically and statistically significant treatment responses when compared to patients with similar baseline characteristics in the control condition. The study team also hypothesizes that the treatment effects will be greatest at the 1-6 month post-injury time points that are temporally correlated with the period of active intervention.
Interventions
BEHAVIORALMotivational Interviewing
BEHAVIORALCognitive Behavioral Therapy Elements
BEHAVIORALCare Management
DRUGFluoxetine
Anti-depressant
DRUGFluvoxamine
Anti-depressant
DRUGParoxetine
Anti-depressant
DRUGSertraline
Anti-depressant
DRUGCitalopram
Anti-depressant
DRUGVenlafaxine
Anti-depressant
DRUGDuloxetine
Anti-depressant
DRUGMirtazapine
Anti-depressant
DRUGDiphenhydramine
Sleep medication
DRUGTrazodone
Sleep medication
DRUGPrazosin
Sleep medication
Sponsors
National Institutes of Health (NIH)
National Institute of Mental Health (NIMH)
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patient currently admitted to inpatient/emergency department for a traumatic injury
Exclusion criteria
* Non-English speaking * Self-inflicted injury * Actively psychotic * Incarcerated or in custody * Less than 35 on PTSD Checklist * Less than 3 items on PTSD medical record screen * Less than 2 pieces of contact information
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD. |
| Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome. |
| Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome. |
| Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Baseline, 3-month, 6-month, 12-month | The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-36 Quality of Life | Baseline, 3-month, 6-month, 12-month | The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health. |
| TSOS Patient Satisfaction: Overall Health Care | Baseline, 3-month, 6-month, 12-month | Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied. |
| Number of Participants With Suicidal Ideation | Baseline, 3-month, 6-month, 12-month | Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome. |
| Number of Participants Endorsing a Single Item That Assesses Marijuana Use | Baseline, 3-month, 6-month, 12-month | Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use. |
| TSOS Patient Satisfaction: Mental Health Care | Baseline, 3 Month, 6 Month, 12 Month | Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied. |
| Number of Participants Endorsing a Single Item That Assesses Stimulant Use | Baseline, 3-month, 6-month, 12-month | Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use. |
| Number of Participants Endorsing a Single Item That Assesses Opioid Use | Baseline, 3-month, 6-month, 12-month | Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use. |
| Cognitive Impairment Scale | Baseline, 3-month, 6-month, 12-month | The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome. |
| Brief Pain Inventory | Baseline, 3-month, 6-month, 12-month | A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention The intervention aims to prevent the development of chronic PTSD and depressive symptoms, alcohol use problems, and enduring physical disability in survivors of both traumatic brain injury(TBI) and non-TBI injuries. The intervention utilizes a computerized decision support tool to flexibly target these multiple conditions including and includes care management, motivational interviewing, cognitive behavioral therapy elements, psychotropic drugs, and psychotherapy elements.
Motivational Interviewing
Cognitive Behavioral Therapy Elements
Care Management
Fluoxetine: Anti-depressant
Fluvoxamine: Anti-depressant
Paroxetine: Anti-depressant
Sertraline: Anti-depressant
Citalopram: Anti-depressant
Venlafaxine: Anti-depressant
Duloxetine: Anti-depressant
Mirtazapine: Anti-depressant
Diphenhydramine: Sleep medication
Trazodone: Sleep medication
Prazosin: Sleep medication | 265 |
| Usual Care Enhanced standard care practices will be administered to this arm. This enhancement is sharing distressing emotional symptoms at recruitment with the attending nursing staff to address with patient subject. | 370 |
| Total | 635 |
Baseline characteristics
| Characteristic | Intervention | Total | Usual Care |
|---|---|---|---|
| Age, Continuous | 37.6 years STANDARD_DEVIATION 13.4 | 39.0 years STANDARD_DEVIATION 14.2 | 39.9 years STANDARD_DEVIATION 14.8 |
| Baseline PCL-C total score | 54.0 units on a scale STANDARD_DEVIATION 12.6 | 52.1 units on a scale STANDARD_DEVIATION 11.9 | 50.7 units on a scale STANDARD_DEVIATION 11.2 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 50 Participants | 102 Participants | 52 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 214 Participants | 530 Participants | 316 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Race American Indian | 6 Participants | 15 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Asian | 2 Participants | 4 Participants | 2 Participants |
| Race/Ethnicity, Customized Race Black | 89 Participants | 218 Participants | 129 Participants |
| Race/Ethnicity, Customized Race Mixed | 11 Participants | 20 Participants | 9 Participants |
| Race/Ethnicity, Customized Race Other | 27 Participants | 59 Participants | 32 Participants |
| Race/Ethnicity, Customized Race Pacific Islander | 3 Participants | 4 Participants | 1 Participants |
| Race/Ethnicity, Customized Race White | 127 Participants | 315 Participants | 188 Participants |
| Sex: Female, Male Female | 147 Participants | 308 Participants | 161 Participants |
| Sex: Female, Male Male | 118 Participants | 327 Participants | 209 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 6 / 265 | 3 / 370 |
| other Total, other adverse events | 134 / 265 | 197 / 370 |
| serious Total, serious adverse events | 15 / 265 | 13 / 370 |
Outcome results
Primary
Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury
The investigators will use the Alcohol Use Disorders Identification Test (AUDIT) as a continuous measure. The 10-item scale score ranges from 0-40, with higher values indicating a worse outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Change from Baseline at 3 Months | -2.04 score on a scale | Standard Error 0.21 |
| Intervention | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Change from Baseline at 6 Months | -1.69 score on a scale | Standard Error 0.22 |
| Intervention | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Change from Baseline at 12 Months | -1.81 score on a scale | Standard Error 0.23 |
| Usual Care | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Change from Baseline at 3 Months | -1.90 score on a scale | Standard Error 0.18 |
| Usual Care | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Change from Baseline at 6 Months | -1.63 score on a scale | Standard Error 0.19 |
| Usual Care | Change From Baseline Alcohol Use Disorders Identification Over the Course of the Year After Injury | Change from Baseline at 12 Months | -1.45 score on a scale | Standard Error 0.19 |
Primary
Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury
The investigators will use the Patient Health Questionnaire 9-item Depression Scale (PHQ-9). The scoring of the scale ranges from a minimum of 0 to a maximum of 27, with higher scores indicating a worse outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Change from Baseline at 3 Months | -0.79 score on a scale | Standard Error 0.4 |
| Intervention | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Change from Baseline at 6 Months | -1.17 score on a scale | Standard Error 0.45 |
| Intervention | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Change from Baseline at 12 Months | -1.84 score on a scale | Standard Error 0.52 |
| Usual Care | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Change from Baseline at 3 Months | -0.50 score on a scale | Standard Error 0.35 |
| Usual Care | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Change from Baseline at 6 Months | -0.90 score on a scale | Standard Error 0.38 |
| Usual Care | Change From Baseline Patient Health Questionnaire 9 Item Depression Scale Over the Course of the Year After Injury | Change from Baseline at 12 Months | -2.16 score on a scale | Standard Error 0.43 |
Primary
Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury
The investigators will use the PTSD Checklist - Civilian (PCL-C). The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. The measure can also provide a rating of symptoms consistent with a diagnosis of PTSD.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Change from Baseline at 3 Months | -1.65 score on a scale | Standard Error 0.86 |
| Intervention | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Change from Baseline at 6 Months | -4.02 score on a scale | Standard Error 0.99 |
| Intervention | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Change from Baseline at 12 Months | -5.51 score on a scale | Standard Error 1.18 |
| Usual Care | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Change from Baseline at 3 Months | 0.08 score on a scale | Standard Error 0.74 |
| Usual Care | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Change from Baseline at 6 Months | -1.44 score on a scale | Standard Error 0.83 |
| Usual Care | Change From Baseline PTSD Checklist- Civilian (PCL-C) Over the Course of the Year After Injury | Change from Baseline at 12 Months | -4.25 score on a scale | Standard Error 0.97 |
Primary
Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury
The investigators used the Medical Outcomes Study Short Form healthy survey (MOS SF-12/36) physical components summary to assess physical function. The minimum and maximum scores are 0-100 with higher scores representing a better outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Change from Baseline at 3 Months | -16.78 score on a scale | Standard Error 0.69 |
| Intervention | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Change from Baseline at 6 Months | -14.17 score on a scale | Standard Error 0.79 |
| Intervention | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Change from Baseline at 12 Months | -13.23 score on a scale | Standard Error 0.94 |
| Usual Care | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Change from Baseline at 3 Months | -15.90 score on a scale | Standard Error 0.59 |
| Usual Care | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Change from Baseline at 6 Months | -13.83 score on a scale | Standard Error 0.66 |
| Usual Care | Change From Baseline Short Form (SF)-12/36 Physical Function Over the Course of the Year After Injury | Change from Baseline at 12 Months | -11.68 score on a scale | Standard Error 0.77 |
Secondary
Brief Pain Inventory
A brief measure scored on a 0 to 10 scale to assess a patient's pain, with a higher score indicating more severe pain; a score of 0 indicates no pain and a score of 10 indicates very severe pain.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Brief Pain Inventory | Baseline | 6.8 score on a scale | Standard Deviation 2.4 |
| Intervention | Brief Pain Inventory | 6 Month | 4.1 score on a scale | Standard Deviation 3.1 |
| Intervention | Brief Pain Inventory | 3 Month | 4.3 score on a scale | Standard Deviation 2.9 |
| Intervention | Brief Pain Inventory | 12 Month | 3.9 score on a scale | Standard Deviation 3 |
| Usual Care | Brief Pain Inventory | 12 Month | 3.8 score on a scale | Standard Deviation 3 |
| Usual Care | Brief Pain Inventory | Baseline | 6.7 score on a scale | Standard Deviation 2.7 |
| Usual Care | Brief Pain Inventory | 3 Month | 4.7 score on a scale | Standard Deviation 2.8 |
| Usual Care | Brief Pain Inventory | 6 Month | 4.5 score on a scale | Standard Deviation 3 |
Secondary
Cognitive Impairment Scale
The investigators will use the National Study on the Costs and Outcomes of Trauma (NSCOT) Cognitive Screen, a 4 - Item Traumatic Brain Injury / Post-concussive Symptom Screen. The scoring of the scale ranges from a minimum of 4 to a maximum of 20, with lower scores indicating a worse outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | Cognitive Impairment Scale | Baseline | 13.5 score on a scale | Standard Deviation 4.6 |
| Intervention | Cognitive Impairment Scale | 3 Month | 13.3 score on a scale | Standard Deviation 4.5 |
| Intervention | Cognitive Impairment Scale | 6 Month | 13.2 score on a scale | Standard Deviation 4.7 |
| Intervention | Cognitive Impairment Scale | 12 Month | 13.8 score on a scale | Standard Deviation 4.7 |
| Usual Care | Cognitive Impairment Scale | 12 Month | 14.2 score on a scale | Standard Deviation 4.1 |
| Usual Care | Cognitive Impairment Scale | Baseline | 13.4 score on a scale | Standard Deviation 4.5 |
| Usual Care | Cognitive Impairment Scale | 6 Month | 13.4 score on a scale | Standard Deviation 4.1 |
| Usual Care | Cognitive Impairment Scale | 3 Month | 13.2 score on a scale | Standard Deviation 4.5 |
Secondary
Number of Participants Endorsing a Single Item That Assesses Marijuana Use
Single items that assess marijuana use. Single item self-report dichotomized as none versus at least monthly use.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | Baseline | 125 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | 3 Month | 60 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | 6 Month | 60 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | 12 Month | 51 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | 12 Month | 79 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | Baseline | 177 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | 6 Month | 82 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Marijuana Use | 3 Month | 72 Participants |
Secondary
Number of Participants Endorsing a Single Item That Assesses Opioid Use
Single items that assess non-prescribed opioid use. Single item self-report dichotomized as none versus at least monthly use.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants Endorsing a Single Item That Assesses Opioid Use | 6 Month | 4 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Opioid Use | 3 Month | 4 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Opioid Use | 12 Month | 6 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Opioid Use | Baseline | 18 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Opioid Use | 12 Month | 6 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Opioid Use | 3 Month | 15 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Opioid Use | 6 Month | 20 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Opioid Use | Baseline | 44 Participants |
Secondary
Number of Participants Endorsing a Single Item That Assesses Stimulant Use
Single items that assess non-prescribed stimulant use. Single item self-report dichotomized as none versus at least monthly use.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | Baseline | 58 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | 3 Month | 9 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | 6 Month | 7 Participants |
| Intervention | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | 12 Month | 8 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | 12 Month | 16 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | Baseline | 77 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | 6 Month | 22 Participants |
| Usual Care | Number of Participants Endorsing a Single Item That Assesses Stimulant Use | 3 Month | 17 Participants |
Secondary
Number of Participants With Suicidal Ideation
Item 9 of the Patient Health Questionnaire 9-item (PHQ-9) scale assesses suicidal ideation. It is scored from 0 to 3, with a score of 1 or greater indicating a patient has suicidal ideation. Participants with a PHQ-9 item 9 score of greater than or equal to 1 are reported for this outcome.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Intervention | Number of Participants With Suicidal Ideation | Baseline | 67 Participants |
| Intervention | Number of Participants With Suicidal Ideation | 3 Month | 69 Participants |
| Intervention | Number of Participants With Suicidal Ideation | 6 Month | 63 Participants |
| Intervention | Number of Participants With Suicidal Ideation | 12 Month | 51 Participants |
| Usual Care | Number of Participants With Suicidal Ideation | 12 Month | 92 Participants |
| Usual Care | Number of Participants With Suicidal Ideation | Baseline | 90 Participants |
| Usual Care | Number of Participants With Suicidal Ideation | 6 Month | 106 Participants |
| Usual Care | Number of Participants With Suicidal Ideation | 3 Month | 99 Participants |
Secondary
SF-36 Quality of Life
The SF-36 assess quality of life domains that span emotional health, overall health status, and role function; a score of 100 indicates perfect health and a score of 0 indicates extremely poor health.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | SF-36 Quality of Life | Baseline | 44.3 score on a scale | Standard Deviation 13.9 |
| Intervention | SF-36 Quality of Life | 3 Month | 38.3 score on a scale | Standard Deviation 12.4 |
| Intervention | SF-36 Quality of Life | 6 Month | 38.4 score on a scale | Standard Deviation 14 |
| Intervention | SF-36 Quality of Life | 12 Month | 39.2 score on a scale | Standard Deviation 13.6 |
| Usual Care | SF-36 Quality of Life | 12 Month | 41.4 score on a scale | Standard Deviation 11.9 |
| Usual Care | SF-36 Quality of Life | Baseline | 45.1 score on a scale | Standard Deviation 13 |
| Usual Care | SF-36 Quality of Life | 6 Month | 39.5 score on a scale | Standard Deviation 12.2 |
| Usual Care | SF-36 Quality of Life | 3 Month | 39.1 score on a scale | Standard Deviation 13 |
Secondary
TSOS Patient Satisfaction: Mental Health Care
Satisfaction with mental health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time frame: Baseline, 3 Month, 6 Month, 12 Month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | TSOS Patient Satisfaction: Mental Health Care | Baseline | 4.1 score on a scale | Standard Deviation 1 |
| Intervention | TSOS Patient Satisfaction: Mental Health Care | 3 Month | 3.6 score on a scale | Standard Deviation 1.1 |
| Intervention | TSOS Patient Satisfaction: Mental Health Care | 6 Month | 3.6 score on a scale | Standard Deviation 1.1 |
| Intervention | TSOS Patient Satisfaction: Mental Health Care | 12 Month | 3.7 score on a scale | Standard Deviation 1.1 |
| Usual Care | TSOS Patient Satisfaction: Mental Health Care | 12 Month | 3.5 score on a scale | Standard Deviation 1.1 |
| Usual Care | TSOS Patient Satisfaction: Mental Health Care | Baseline | 4.0 score on a scale | Standard Deviation 1.1 |
| Usual Care | TSOS Patient Satisfaction: Mental Health Care | 6 Month | 3.4 score on a scale | Standard Deviation 4.1 |
| Usual Care | TSOS Patient Satisfaction: Mental Health Care | 3 Month | 3.5 score on a scale | Standard Deviation 1.1 |
Secondary
TSOS Patient Satisfaction: Overall Health Care
Satisfaction with health care was rated on a scale of 1 to 5, with 1 indicating very dissatisfied and 5 indicating very satisfied.
Time frame: Baseline, 3-month, 6-month, 12-month
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention | TSOS Patient Satisfaction: Overall Health Care | Baseline | 4.4 score on a scale | Standard Deviation 0.9 |
| Intervention | TSOS Patient Satisfaction: Overall Health Care | 3 Month | 3.9 score on a scale | Standard Deviation 1.1 |
| Intervention | TSOS Patient Satisfaction: Overall Health Care | 6 Month | 4.0 score on a scale | Standard Deviation 1.1 |
| Intervention | TSOS Patient Satisfaction: Overall Health Care | 12 Month | 3.9 score on a scale | Standard Deviation 1.1 |
| Usual Care | TSOS Patient Satisfaction: Overall Health Care | 12 Month | 3.8 score on a scale | Standard Deviation 1.2 |
| Usual Care | TSOS Patient Satisfaction: Overall Health Care | Baseline | 4.4 score on a scale | Standard Deviation 0.9 |
| Usual Care | TSOS Patient Satisfaction: Overall Health Care | 6 Month | 3.8 score on a scale | Standard Deviation 1.1 |
| Usual Care | TSOS Patient Satisfaction: Overall Health Care | 3 Month | 3.8 score on a scale | Standard Deviation 1.1 |