Alcohol Use, Depression, Drug Use, Posttraumatic Stress Disorder, Suicide, Traumatic Brain Injury
Conditions
Keywords
Posttraumatic Stress Disorder, Depression, Suicide, Traumatic Brain Injury, Alcohol Use, Drug Use, Information Technology
Brief summary
After traumatic injuries some people have difficulty returning to the routine of their everyday activities and may experience physical and emotional pain. The purpose of this study is to identify new ways of providing support for physically injured trauma survivors. All study procedures are designed to work around patient needs and be as flexible as possible in order to best fit into patients' post-injury recovery. Patients who are eligible for the study are randomly assigned to receive care as usual, or the new method of treatment, with the study Trauma Support Specialist (TSS). This TSS will be in contact with the patient for the next three months; they may visit the patient at the hospital or at outpatient medical appointments. The TSS will also be available to talk with the patient over the telephone. Overall, the TSS will be working with the patient to help with difficulties returning to his or her routine and overcoming physical and emotional pain experienced after the injury. We believe that patients who receive the new method of treatment, will be more able to return to daily routines and/or cope with the emotional stress that can occur after an injury. Intervention technology innovations including mHealth applications and web-based links will be included in the investigation.
Detailed description
Clinical feasibility randomized clinical trial (RCT) pilot of integrating information technology advancements into Early PTSD Screening and Intervention. Design Overview: Between 30-200 injured trauma survivors who are initially admitted to either the Harborview inpatient wards or emergency department acute care settings will be enrolled in the study. If patients agree to participate, they will be engaged by a research assistant to complete a baseline assessment battery. Following the battery, all patients will be engaged in an initial technology readiness assessment to gauge comfort and skill using a variety of devices (e.g., smartphones, cellular phones, tablets, and laptop computers) that could potentially be utilized for delivery of interventions. Patients will then be randomized to either care as usual or to the stepped-care technology-based educational intervention. Patients randomized to the intervention condition will be met by a trauma support specialist. Intervention patients who endorse elevated substance use and/or mental health symptoms, including PTSD, depression, suicidal ideation, chronic pain, and postconcussive symptoms, will receive up to 3 months of motivational interviewing and/or cognitive behavioral therapy delivered by the trauma support specialist in person or over the telephone. The trauma support specialist may utilize mHealth technologies including websites and applications available on smartphones and tablet devices, as strategies to compliment CBT approaches that target specific areas of concern. However, the psychotherapeutic intervention embedded within the Stepped Care protocol is conceived of being fundamentally separate from the mHealth tools that may also be mentioned during discussions between the trauma support specialist and the patient. Inherent throughout the intervention is a focus on obtaining acceptability information from patients related to all aspects of the intervention and interpersonal experiences with the trauma support specialist, as well as any technology-based assessments and mHealth tools that may compliment the stepped care protocol. Patients will receive up to 3 consecutive months of trauma support specialist support post-injury. Follow-up assessments will occur at 1, 3, and 6 months following the baseline assessment, with additional acceptability assessments completed for specific aspects of the intervention listed above.
Interventions
BEHAVIORALStepped Care Management
All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the 3-6 month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-6 months.
Sponsors
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
14 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Score ≥3 on PTSD automated screening algorithm * Score ≥35 on PTSD checklist (PCL-C)
Exclusion criteria
* Non-English speaking * Under 14 years of age * Patients in need of acute psychiatric intervention (e.g., suicide attempt, psychosis) * Suffered head, spinal cord, or other sever injuries that prevent participation in the inpatient ward interview.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used. |
| Change in Depression Symptoms Over the Course of the Six Months After Injury | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used. |
| Technology Use | Baseline to 6 months | The investigators used laptop tracking software to determine technology usage. |
| Feasibility/Acceptability of Intervention | Baseline to 6 months | The investigators used laptop tracking software to assess number of patients using laptops. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Alcohol Use Problems | The investigators assessed at baseline, 1-, 3-, and 6-month. | The investigators used 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. No sub scales were used. |
| Physical Functioning | The investigators assessed at baseline, 1-, 3-, and 6-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. No other subscales will be used. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Stepped Care Management Case management, information technology/mHealth innovations, psychotherapy, and psychopharmacology.: All patients randomized to receive the stepped care management procedures will meet with the trauma support specialist (TSS) prior to discharge from the hospital, who will provide coaching on use of mobile technology for mental health concerns. The TSS will complete follow-up correspondence across the three month time period to assess mental health functioning and use of information technology that addresses medical concerns. Patients who report barriers to mHealth technologies and request additional therapeutic services for mental health concerns assistance will receive evidence-based motivational interviewing and cognitive behavioral intervention procedures that can span up to 3-months. | 60 |
| Usual Care Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them. | 61 |
| Total | 121 |
Baseline characteristics
| Characteristic | Stepped Care Management | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 5 Participants | 4 Participants | 9 Participants |
| Age, Categorical Between 18 and 65 years | 55 Participants | 57 Participants | 112 Participants |
| Age, Continuous | 42.8 years STANDARD_DEVIATION 14.7 | 43.5 years STANDARD_DEVIATION 14.8 | 43.2 years STANDARD_DEVIATION 14.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 10 Participants | 8 Participants | 18 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 50 Participants | 53 Participants | 103 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 13 Participants | 18 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 6 Participants | 20 Participants |
| Race (NIH/OMB) More than one race | 8 Participants | 3 Participants | 11 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 1 Participants | 6 Participants |
| Race (NIH/OMB) White | 27 Participants | 35 Participants | 62 Participants |
| Sex: Female, Male Female | 21 Participants | 22 Participants | 43 Participants |
| Sex: Female, Male Male | 39 Participants | 39 Participants | 78 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 60 | 0 / 61 |
| other Total, other adverse events | 31 / 60 | 36 / 61 |
| serious Total, serious adverse events | 0 / 60 | 0 / 61 |
Outcome results
Primary
Change in Depression Symptoms Over the Course of the Six Months After Injury
The investigators used the Patient Health Questionnaire (PHQ-9) as a continuous measure, with scores ranging from 1 to 27. Higher scores represent a worse outcome. No subscales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Management | Change in Depression Symptoms Over the Course of the Six Months After Injury | Baseline | 14.3 units on a scale | Standard Deviation 5.7 |
| Stepped Care Management | Change in Depression Symptoms Over the Course of the Six Months After Injury | 1 month | 13.2 units on a scale | Standard Deviation 6.3 |
| Stepped Care Management | Change in Depression Symptoms Over the Course of the Six Months After Injury | 3 month | 12.5 units on a scale | Standard Deviation 6.4 |
| Stepped Care Management | Change in Depression Symptoms Over the Course of the Six Months After Injury | 6 month | 12.5 units on a scale | Standard Deviation 7.2 |
| Usual Care | Change in Depression Symptoms Over the Course of the Six Months After Injury | 6 month | 14.4 units on a scale | Standard Deviation 7.2 |
| Usual Care | Change in Depression Symptoms Over the Course of the Six Months After Injury | Baseline | 15.0 units on a scale | Standard Deviation 5 |
| Usual Care | Change in Depression Symptoms Over the Course of the Six Months After Injury | 3 month | 14.1 units on a scale | Standard Deviation 7.4 |
| Usual Care | Change in Depression Symptoms Over the Course of the Six Months After Injury | 1 month | 13.8 units on a scale | Standard Deviation 6.1 |
p-value: 0.69Chi-squared
Primary
Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury
The investigators used the PTSD Checklist - Civilian (PCL-C) as a continuous measure. The scoring of the scale ranges from a minimum of 17 to a maximum of 85, with higher scores indicating a worse outcome. No subscales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Management | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | Baseline | 47.0 units on a scale | Standard Deviation 10.2 |
| Stepped Care Management | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 1 month | 43.9 units on a scale | Standard Deviation 16.1 |
| Stepped Care Management | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 3 month | 41.4 units on a scale | Standard Deviation 16 |
| Stepped Care Management | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 6 month | 41.7 units on a scale | Standard Deviation 16.2 |
| Usual Care | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 6 month | 47.1 units on a scale | Standard Deviation 16.6 |
| Usual Care | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | Baseline | 47.0 units on a scale | Standard Deviation 10.9 |
| Usual Care | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 3 month | 45.4 units on a scale | Standard Deviation 16 |
| Usual Care | Change in Post Traumatic Stress Disorder (PTSD) Symptoms Over the Course of the Six Months After Injury | 1 month | 43.6 units on a scale | Standard Deviation 15.7 |
p-value: 0.05Chi-squared
Primary
Feasibility/Acceptability of Intervention
The investigators used laptop tracking software to assess number of patients using laptops.
Time frame: Baseline to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Stepped Care Management | Feasibility/Acceptability of Intervention | 37 Participants |
| Usual Care | Feasibility/Acceptability of Intervention | 33 Participants |
Primary
Technology Use
The investigators used laptop tracking software to determine technology usage.
Time frame: Baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Stepped Care Management | Technology Use | 24.76 minutes | Standard Deviation 42.51 |
| Usual Care | Technology Use | 16.05 minutes | Standard Deviation 26.82 |
Secondary
Alcohol Use Problems
The investigators used 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. No sub scales were used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Management | Alcohol Use Problems | 6 month | 2.7 units on a scale | Standard Deviation 3 |
| Stepped Care Management | Alcohol Use Problems | 1 month | 1.5 units on a scale | Standard Deviation 2.7 |
| Stepped Care Management | Alcohol Use Problems | Baseline | 4.5 units on a scale | Standard Deviation 3.4 |
| Stepped Care Management | Alcohol Use Problems | 3 month | 2.4 units on a scale | Standard Deviation 3.1 |
| Usual Care | Alcohol Use Problems | 6 month | 2.1 units on a scale | Standard Deviation 2.8 |
| Usual Care | Alcohol Use Problems | 3 month | 1.9 units on a scale | Standard Deviation 3.1 |
| Usual Care | Alcohol Use Problems | Baseline | 4.2 units on a scale | Standard Deviation 3.9 |
| Usual Care | Alcohol Use Problems | 1 month | 1.0 units on a scale | Standard Deviation 2.3 |
p-value: 0.97Chi-squared
Secondary
Physical Functioning
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. No other subscales will be used.
Time frame: The investigators assessed at baseline, 1-, 3-, and 6-month.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Stepped Care Management | Physical Functioning | 6 month | 36.9 units on a scale | Standard Deviation 11.5 |
| Stepped Care Management | Physical Functioning | Baseline | 47.3 units on a scale | Standard Deviation 13 |
| Stepped Care Management | Physical Functioning | 1 month | 27.9 units on a scale | Standard Deviation 11.8 |
| Stepped Care Management | Physical Functioning | 3 month | 35.2 units on a scale | Standard Deviation 13.1 |
| Usual Care | Physical Functioning | 3 month | 33.6 units on a scale | Standard Deviation 13.4 |
| Usual Care | Physical Functioning | 6 month | 34.6 units on a scale | Standard Deviation 12.3 |
| Usual Care | Physical Functioning | 1 month | 27.4 units on a scale | Standard Deviation 11.6 |
| Usual Care | Physical Functioning | Baseline | 42.8 units on a scale | Standard Deviation 14 |
p-value: 0.71Chi-squared