Depression, Stress Disorders, Posttraumatic
Conditions
Keywords
Stress Disorders, Posttraumatic, Delivery of Health Care, Integrated, Primary Health Care, Veterans, Depression
Brief summary
The study is an evaluation of a systemic intervention to enhance the delivery of care according to practice guidelines for posttraumatic stress disorder (PTSD). The immediate objectives are to (1) implement three component model (3CM) in VA primary care clinics; and (2) evaluate the effects of 3CM on clinician behavior and patient outcomes. The long-term objectives are to generate information to support implementation research on the RESPECT model for treating PTSD in primary care and ultimately, the implementation of the model in VHA to provide care to veterans with PTSD.
Detailed description
3CM consists of (1) a prepared practice, (2) care management, and (3) enhanced mental health support. A prepared practice refers to education for primary care clinicians and office staff about practice guidelines and evidence-based care, the skills needed for use of assessment measures, and the use of communication forms and routines. The education plan consists of predisposing activities, including active teaching and learning, and enabling and reinforcing activities in order to help clinicians use newly acquired skills and to reinforce the continued use of these skills in practice. Care management is accomplished by telephone, usually by a centrally located care manager during acute phase treatment and follow up to answer patient questions, promote adherence to the clinician's management plan, and help patients overcome barriers to adherence. Enhanced mental health support is provided by a psychiatrist who supervises care managers by telephone, provides informal consultation to primary care clinicians, and helps to increase the quantity or quality of mental health referral resources.
Interventions
BEHAVIORALThree Component Model of Collaborative Care
Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians.
Sponsors
US Department of Veterans Affairs
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
* Military Veterans in Primary Care Clinics who meet diagnostic criteria for PTSD in one of the 5 sites in Texas where this study is being conducted. * Must have regular access to a telephone and speak English.
Exclusion criteria
* Cognitive impairment * A history of psychosis or mania * Prominent current suicidal ideation * Current substance dependence * Current engagement in mental health treatment
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Symptom Severity | 3 and 6 months after initial assessment | PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Depression | 3 and 6 months after initial assessment | Measure using the Hopkins Symptom Checklist-20 |
| SF-36 Mental Component | 3 and 6 months after initial assessment | — |
| SF-36 Physical Component | 3 and 6 months after initial assessment | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Three Component Model Three Component Model of Collaborative Care: Patients randomized to 3CM will receive telephone care management along with usual care by VA clinicians. | 96 |
| Usual Care Patients randomized to Usual Care will receive care as usual by VA clinicians. | 99 |
| Total | 195 |
Baseline characteristics
| Characteristic | Three Component Model | Usual Care | Total |
|---|---|---|---|
| Age, Customized Age, >=18 | 46.1 years | 44.4 years | NA years |
| Depression (Hopkins Symptom Checklist-20) | 1.98 units on a scale STANDARD_DEVIATION 0.69 | 2.06 units on a scale STANDARD_DEVIATION 0.78 | NA units on a scale |
| PTSD symptom severity (used Posttraumatic Diagnostic Scale (PDS)) | 33.2 units on a scale STANDARD_DEVIATION 8.3 | 34.0 units on a scale STANDARD_DEVIATION 9.7 | NA units on a scale |
| Region of Enrollment United States | 96 participants | 99 participants | 195 participants |
| Sex: Female, Male Female | 7 Participants | 10 Participants | 17 Participants |
| Sex: Female, Male Male | 89 Participants | 89 Participants | 178 Participants |
| SF-36 Mental Component | 33.8 units on a scale STANDARD_DEVIATION 8.8 | 32.7 units on a scale STANDARD_DEVIATION 8.1 | NA units on a scale |
| SF-36 Physical Component | 42.2 units on a scale STANDARD_DEVIATION 13 | 43.4 units on a scale STANDARD_DEVIATION 12.6 | NA units on a scale |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 96 | 0 / 99 |
| serious Total, serious adverse events | 5 / 96 | 4 / 99 |
Outcome results
Primary
PTSD Symptom Severity
PTSD Symptom Severity was measured using the Postraumatic Diagnostic Scale (PDS)
Time frame: 3 and 6 months after initial assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm1/Three Component Model of Care Collaborative Care | PTSD Symptom Severity | 3 months after initial assessment | 31.4 units on a scale | Standard Deviation 10.2 |
| Arm1/Three Component Model of Care Collaborative Care | PTSD Symptom Severity | 6 months after initial assessment | 30.2 units on a scale | Standard Deviation 10.3 |
| Arm 2/Usual Care | PTSD Symptom Severity | 3 months after initial assessment | 31.5 units on a scale | Standard Deviation 10.3 |
| Arm 2/Usual Care | PTSD Symptom Severity | 6 months after initial assessment | 29.9 units on a scale | Standard Deviation 10.8 |
Secondary
Depression
Measure using the Hopkins Symptom Checklist-20
Time frame: 3 and 6 months after initial assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm1/Three Component Model of Care Collaborative Care | Depression | 3 months after initial assessment | 1.8 units on a scale | Standard Deviation 0.8 |
| Arm1/Three Component Model of Care Collaborative Care | Depression | 6 months after initial assessment | 1.81 units on a scale | Standard Deviation 0.84 |
| Arm 2/Usual Care | Depression | 3 months after initial assessment | 1.84 units on a scale | Standard Deviation 0.82 |
| Arm 2/Usual Care | Depression | 6 months after initial assessment | 1.83 units on a scale | Standard Deviation 0.9 |
Secondary
SF-36 Mental Component
Time frame: 3 and 6 months after initial assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm1/Three Component Model of Care Collaborative Care | SF-36 Mental Component | Mental Component-3 months after initial assessment | 33.9 units on a scale | Standard Deviation 8.3 |
| Arm1/Three Component Model of Care Collaborative Care | SF-36 Mental Component | Mental Component-6 months after initial assessment | 33.7 units on a scale | Standard Deviation 9.4 |
| Arm 2/Usual Care | SF-36 Mental Component | Mental Component-3 months after initial assessment | 33.8 units on a scale | Standard Deviation 8.1 |
| Arm 2/Usual Care | SF-36 Mental Component | Mental Component-6 months after initial assessment | 33.4 units on a scale | Standard Deviation 8.1 |
Secondary
SF-36 Physical Component
Time frame: 3 and 6 months after initial assessment
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Arm1/Three Component Model of Care Collaborative Care | SF-36 Physical Component | Physical Component-3 months after initial assessme | 43.8 units on a scale | Standard Deviation 13.1 |
| Arm1/Three Component Model of Care Collaborative Care | SF-36 Physical Component | Physical Component-6 monthsafter initial assessmen | 44.4 units on a scale | Standard Deviation 12.6 |
| Arm 2/Usual Care | SF-36 Physical Component | Physical Component-3 months after initial assessme | 43.7 units on a scale | Standard Deviation 12.2 |
| Arm 2/Usual Care | SF-36 Physical Component | Physical Component-6 monthsafter initial assessmen | 44.8 units on a scale | Standard Deviation 11.8 |