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PTSD Coach is a mobile application (app) that aims to teach individuals self-management strategies for symptoms of Post-traumatic Stress Disorder (PTSD). Despite PTSD Coach's use of evidence-based cognitive behavioral strategies there is still a need to test the effectiveness of the app in managing PTSD symptoms. There is research evidence that self-management programs are often underutilized, but that clinician contact can increase patient involvement. The addition of clinician support may enhance the utilization and effectiveness of the PTSD Coach. In Phase 1 the investigators propose to conduct stakeholder interviews with primary care (PC) and mental health (MH) leadership staff to investigate barriers and facilitators to implementing Clinician-Supported (CS-PTSD Coach) to increase the uptake, use, and impact of PTSD Coach by PC patients. The interviews will inform the development of a CS-PTSD Coach protocol and manual that will be used in phase 2. In phase 2 the investigators propose to conduct a feasibility study where 30 (20 eligible) PC Veterans with diagnostic-level or subthreshold PTSD symptoms will be randomized to receive Self-Managed (SM) PTSD Coach or CS-PTSD Coach. The investigators' specific aims are to 1) investigate the feasibility of recruiting and retaining participants and delivering the SM and CS conditions and 2) conduct a preliminary investigation of the efficacy of SM vs. CS. The investigators predict that CS will lead to greater treatment gains than SM. Effect sizes will be generated for the following outcomes: a) reductions in PTSD, depression, and general distress, and increases in health-related functioning, b) increases in knowledge about PTSD symptoms, PTSD management strategies, and patient coping self-efficacy, c) increases in initiation of tradition PTSD treatments.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Clinician-Supported PTSD Coach | Experimental | Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own. |
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| Self-Managed PTSD Coach | Active Comparator | One in-person 10-minute session that provides instructions on how to use the PTSD Coach app. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Clinician-Supported PTSD Coach | Behavioral | Brief primary care-based intervention provided by a mental health clinician who is located in primary care. |
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| Measure | Description | Time Frame |
|---|---|---|
| PTSD Checklist-Specific | Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record | Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention. | 16 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kyle Possemato, Ph.D. | Syracuse VAMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Syracuse VMAC | Syracuse | New York | 13210 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Clinician-Supported PTSD Coach | Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own. Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care. |
| FG001 | Self-Managed PTSD Coach | One in-person 10-minute session that provides instructions on how to use the PTSD Coach app. Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Participants completed self-report measures at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | Clinician-Supported PTSD Coach | Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own. Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | PTSD Checklist-Specific | Measures the 17 symptoms of PTSD according to the DSM-IV. Each symptoms is measured on a 1-5 scale, with higher numbers indicated greater severity. The total range of the scale is 17-85. | Posted | Mean | Standard Deviation | units on a scale | 8 weeks |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Clinician-Supported PTSD Coach | Four 20-minute sessions (2 in-person, 2 by phone) focused on instructions for use, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for the participant to complete on their own. Clinician-Supported PTSD Coach: Brief primary care-based intervention provided by a mental health clinician who is located in primary care. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Kyle Possemato, Ph.D. | Center for Integrated Healthcare, Syracuse Veterans Affairs Medical Center | 315-425-4400 | 53551 | kyle.possmato@va.gov |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| Self-Managed PTSD Coach | Behavioral | One 10 minute session explaining how to use the PTSD Coach mobile app. |
|
| BG001 | Self-Managed PTSD Coach | One in-person 10-minute session that provides instructions on how to use the PTSD Coach app. Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| PTSD Checklist-Specific | Measures the 17 symptoms of PTSD according to the DSM-IV criteria. Each symptom is measured on a 5-point scale ranging from 1-5, with higher numbers equating to more severe symptoms. Measures range is 17-85. The mean provided is for the total score of all symptoms added together. | Mean | Standard Deviation | units on a scale |
|
One in-person 10-minute session that provides instructions on how to use the PTSD Coach app. Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app. |
|
|
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| Secondary | Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record | Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention. | Posted | Number | participants | 16 weeks |
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| 0 |
| 10 |
| 0 |
| 10 |
| EG001 | Self-Managed PTSD Coach | One in-person 10-minute session that provides instructions on how to use the PTSD Coach app. Self-Managed PTSD Coach: One 10 minute session explaining how to use the PTSD Coach mobile app. | 0 | 10 | 0 | 10 |
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