PTSD
Conditions
Brief summary
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.
Interventions
BEHAVIORALClinician-Supported PTSD Coach
Brief primary care-based intervention provided by a mental health clinician who is located in primary care.
BEHAVIORALSelf-Managed PTSD Coach
One 10 minute session explaining how to use the PTSD Coach mobile app.
Sponsors
Syracuse VA Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Enrolled in primary care at the Syracuse VAMC, 2. Significant PTSD symptoms. Total PTSD Checklist Score ≥ 40.
Exclusion criteria
1. Gross cognitive impairment (as measured by the Blessed Orientation-Memory-Concentration; BOMC) 2. Suicide attempt or intent to commit suicide in the last two months (as measured by the Columbia- Suicide Severity Rating Scale 3. Psychotherapy or mental health counseling for PTSD in the last two months that was received outside of VA primary care 4. A new psychotropic medication or a change in dose of a psychotropic medication for PTSD in the last two months that was received outside of VA primary care 5. Intent to begin PTSD treatment in specialty care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PTSD Checklist-Specific | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record | 16 weeks | Attendance of at least one session in the PTSD specialty clinic following the completion of the study intervention. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 10 |
| 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. | 10 |
| Total | 20 |
Baseline characteristics
| Characteristic | Clinician-Supported PTSD Coach | Self-Managed PTSD Coach | Total |
|---|---|---|---|
| Age, Continuous | 41.0 years STANDARD_DEVIATION 7.8 | 42.8 years STANDARD_DEVIATION 15.4 | 41.9 years STANDARD_DEVIATION 11.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 1 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 10 Participants | 9 Participants | 19 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| PTSD Checklist-Specific | 51.0 units on a scale STANDARD_DEVIATION 7.7 | 56.0 units on a scale STANDARD_DEVIATION 15.3 | 53.5 units on a scale STANDARD_DEVIATION 12 |
| Race (NIH/OMB) American Indian or Alaska Native | 2 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 7 Participants | 13 Participants |
| Region of Enrollment United States | 10 participants | 10 participants | 20 participants |
| Sex: Female, Male Female | 1 Participants | 0 Participants | 1 Participants |
| Sex: Female, Male Male | 9 Participants | 10 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
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.
Time frame: 8 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinician-Supported PTSD Coach | PTSD Checklist-Specific | 40.0 units on a scale | Standard Deviation 10.9 |
| Self-Managed PTSD Coach | PTSD Checklist-Specific | 49.8 units on a scale | Standard Deviation 18.1 |
p-value: 0.05ANOVA
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.
Time frame: 16 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Clinician-Supported PTSD Coach | Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record | 7 participants |
| Self-Managed PTSD Coach | Engagement in PTSD Specialty Care as Measured by the Electronic Medical Record | 1 participants |
p-value: 0.05Chi-squared