An interventional study of Stepped Care Management in Posttraumatic Stress Disorder, Depression and Suicide, sponsored by University of Washington. Completed at 1 site in United States. Open to participants aged 14 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.
Sponsored by University of Washington · Not applicable, Interventional, and Treatment
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 121 is above the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →University of Washington is the lead sponsor of 1,397 studies on the registry; 225 are open to participants now.
Of its 154 completed or terminated interventional studies of FDA-regulated products, 132 (86%) have results posted.
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Exclusion Criteria:
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.
Behavioral: Stepped Care Management
Usual care control patients will be given a list of available community resources and encouraged to proceed using all resources available to them.
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.
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.
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.
Technology Use
The investigators used laptop tracking software to determine technology usage.
Time frame: Baseline to 6 months
Feasibility/Acceptability of Intervention
The investigators used laptop tracking software to assess number of patients using laptops.
Time frame: Baseline to 6 months
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.
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.
| Milestone | Stepped Care Management | Usual Care |
|---|---|---|
| Started | 60 | 61 |
| Completed | 51 | 54 |
| Not completed | 9 | 7 |
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.
| units on a scale | Stepped Care Management | Usual Care |
|---|---|---|
| Baseline | 47.0 ± 10.2 | 47.0 ± 10.9 |
| 1 month | 43.9 ± 16.1 | 43.6 ± 15.7 |
| 3 month | 41.4 ± 16.0 | 45.4 ± 16.0 |
| 6 month | 41.7 ± 16.2 | 47.1 ± 16.6 |
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.
| units on a scale | Stepped Care Management | Usual Care |
|---|---|---|
| Baseline | 14.3 ± 5.7 | 15.0 ± 5.0 |
| 1 month | 13.2 ± 6.3 | 13.8 ± 6.1 |
| 3 month | 12.5 ± 6.4 | 14.1 ± 7.4 |
| 6 month | 12.5 ± 7.2 | 14.4 ± 7.2 |
The investigators used laptop tracking software to determine technology usage.
| minutes | Stepped Care Management | Usual Care |
|---|---|---|
| Technology Use | 24.76 ± 42.51 | 16.05 ± 26.82 |
The investigators used laptop tracking software to assess number of patients using laptops.
| Participants | Stepped Care Management | Usual Care |
|---|---|---|
| Feasibility/Acceptability of Intervention | 37 | 33 |
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.
| units on a scale | Stepped Care Management | Usual Care |
|---|---|---|
| Baseline | 4.5 ± 3.4 | 4.2 ± 3.9 |
| 1 month | 1.5 ± 2.7 | 1.0 ± 2.3 |
| 3 month | 2.4 ± 3.1 | 1.9 ± 3.1 |
| 6 month | 2.7 ± 3.0 | 2.1 ± 2.8 |
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.
| units on a scale | Stepped Care Management | Usual Care |
|---|---|---|
| Baseline | 47.3 ± 13.0 | 42.8 ± 14.0 |
| 1 month | 27.9 ± 11.8 | 27.4 ± 11.6 |
| 3 month | 35.2 ± 13.1 | 33.6 ± 13.4 |
| 6 month | 36.9 ± 11.5 | 34.6 ± 12.3 |
Collected over 6 months. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Stepped Care Management | 0/60 (0%) | 0/60 (0%) | 31/60 (51.7%) |
| Usual Care | 0/61 (0%) | 0/61 (0%) | 36/61 (59%) |
| Event | Stepped Care Management | Usual Care |
|---|---|---|
| Suicide ideationPsychiatric disorders | 31/60 | 36/61 |
| Age, Categorical(Participants) | Stepped Care Management | Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 55 | 57 | 112 |
| >=65 years | 5 | 4 | 9 |
| Age, Continuous(years) | Stepped Care Management | Usual Care | Total |
|---|---|---|---|
| Mean | 42.8 ± 14.7 | 43.5 ± 14.8 | 43.2 ± 14.7 |
| Sex: Female, Male(Participants) | Stepped Care Management | Usual Care | Total |
|---|---|---|---|
| Female | 21 | 22 | 43 |
| Male | 39 | 39 | 78 |
| Ethnicity (NIH/OMB)(Participants) | Stepped Care Management | Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 10 | 8 | 18 |
| Not Hispanic or Latino | 50 | 53 | 103 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Stepped Care Management | Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 5 | 13 | 18 |
| Asian | 1 | 1 | 2 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 14 | 6 | 20 |
| White | 27 | 35 | 62 |
| More than one race | 8 | 3 | 11 |
| Unknown or Not Reported | 5 | 1 | 6 |
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