Posttraumatic Stress Disorder
Conditions
Keywords
Stress Disorders, Post-traumatic, Primary Health Care, Mobile Applications, Veterans
Brief summary
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project seeks to improve health care for Veterans by testing the effectiveness of a primary care-based treatment called clinician-supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. If this treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
Detailed description
Posttraumatic Stress Disorder (PTSD) is an often severe and frequently disabling condition. It is associated with compromised health, early mortality, and substantial economic costs. PTSD is common in VA primary care patients; however, brief, effective treatments for PTSD are not available in the primary care setting. Instead, patients with PTSD are referred to mental health settings, yet many patients do not accept these referrals or do not adequately engage in such services. Thus, this project represents a unique opportunity to improve health care for Veterans by examining the effectiveness of a primary care-based treatment called Clinician-Supported PTSD Coach. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. This randomized clinical trial will enroll and treat 260 VA primary care patients (female and male) who have PTSD and are not currently being treated for it. Commonly used, well-established clinical interviews and self-report measures will be used to assess important clinical outcomes. If this direct treatment is found to be effective at reducing PTSD symptoms and increasing use of mental health care, it will provide a tremendous benefit to Veterans with PTSD seen in VA primary care.
Interventions
BEHAVIORALClinician-Supported PTSD Coach
Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks.
BEHAVIORALPrimary Care Mental Health Integrated Care as Usual
Existing primary care mental health integrated treatment will serve as the comparison condition
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Masking description
The CAPS-5 will be administered via phone by a central assessor, blind to condition, at baseline and post-treatment and will be the primary measure of change in PTSD symptom severity.
Intervention model description
Clinician-Supported PTSD Coach (CS PTSD Coach) consists of four 20-30 minute sessions focused on instructions for using the PTSD Coach app, setting symptom reductions goals, and assigning specific PTSD Coach activities (i.e., assessments, management strategies, psycho-educational readings) for completion between sessions. PC-MHI providers deliver CS PTSD Coach using a treatment manual, which was developed and piloted by the PIs. Session 1 will be face-to-face and sessions 2-4 may be face-to-face or by phone, depending on patient preference. To help participants overcome treatment barriers psycho-education about treatment options are provided and active problems solving is encouraged. Specific next steps for treatment or self-management are developed collaboratively, typically in session 4. After session 4, Participants are encouraged to continue using PTSD Coach and have access to the research version of the app until the 24-week follow-up.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Veterans enrolled in primary care within the VA Syracuse and Palo Alto healthcare systems reporting 33 on the PTSD Checklist-5 (PCL-5) and a traumatic event on the Criterion A screener
Exclusion criteria
* Patients will be excluded if they demonstrate symptoms that would not allow them to actively engage in the CS PTSD Coach, i.e., * gross cognitive impairment * Current symptoms of mania or psychosis or who have more pressing concerns that need to be addressed first, i.e., * suicide attempt in the last two months or current intent to commit suicide * Patients with recent suicide attempts or intent are eligible to be enrolled follow the receipt of suicide prevention services * The investigators will also exclude patients that are already receiving psychotherapy or MH counseling for PTSD outside of PC * Started or changed the dose of a psychotropic medication for PTSD in the last two months that was prescribed outside of VA PC * Voice a preference to be directly referred to MH specialty care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | Baseline | The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings. |
| Hospital Administrative Data Showing 2 Mental Health Visits Completed | 16 and 24 weeks | Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Health Questionnaire (PHQ-9) | Baseline, 8 week, 16 week, 24 week | A 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items which can range from 0 as the minimum value to 27 as the maximum value. Higher scores indicate greater depression severity, with a score of 10 or greater indicating probable major depression, and scores of 20 or more severe major depression. |
| PTSD Checklist-5 (PCL-5) | Baseline, 8 week, 16 week, 24 week | The PCL-5 is a 20-item self-report measure assessing how much respondents have been bothered by DSM-5 PTSD symptoms in the past month. Scores can range from 0 to 80 with higher scores reflecting worse PTSD symptom severity. |
| WHOQOL-BREF Social Relationships Subscale | Baseline, 8 week, 16 week, 24 week | The social relationships (3 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-15 with higher scores reflecting better quality of life. |
| WHOQOL-BREF Psychological Health Subscale | Baseline, 8 week, 16 week, 24 week | The psychological health (6 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-30 with higher scores reflecting better quality of life. |
| Client Satisfaction Questionnaire (CSQ) | 8 week | The CSQ is a widely used 8-item self-report measure assessing patient satisfaction with care. Scores can range from 8 to 32 with higher scores reflecting greater satisfaction. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Clinician-Supported PTSD Coach Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consisted of 4 brief sessions over 8 weeks.
Clinician-Supported PTSD Coach: Clinician-supported PTSD Coach is primary care-based treatment. In this treatment a primary care mental health clinician guides patients in using the PTSD Coach mobile app to learn about PTSD symptoms, treatment options, and strategies to cope with common PTSD-related concerns. It consists of 4 brief sessions over 8 weeks. | 115 |
| Primary Care Mental Health Integrated Care as Usual Existing primary care mental health integrated treatment will serve as the comparison condition
Primary Care Mental Health Integrated Care as Usual: Existing primary care mental health integrated treatment will serve as the comparison condition | 119 |
| Total | 234 |
Baseline characteristics
| Characteristic | Clinician-Supported PTSD Coach | Total | Primary Care Mental Health Integrated Care as Usual |
|---|---|---|---|
| Age, Continuous | 50.04 years STANDARD_DEVIATION 15.4 | 50.92 years STANDARD_DEVIATION 15.43 | 51.75 years STANDARD_DEVIATION 15.47 |
| Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 28.52 units on a scale STANDARD_DEVIATION 10.4 | 29.28 units on a scale STANDARD_DEVIATION 10.38 | 30.01 units on a scale STANDARD_DEVIATION 10.36 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 9 Participants | 23 Participants | 14 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 105 Participants | 210 Participants | 105 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Race African American | 14 Participants | 34 Participants | 20 Participants |
| Race/Ethnicity, Customized Race Asian/Pacific American | 6 Participants | 12 Participants | 6 Participants |
| Race/Ethnicity, Customized Race Caucasian | 86 Participants | 167 Participants | 81 Participants |
| Race/Ethnicity, Customized Race Multiracial | 4 Participants | 11 Participants | 7 Participants |
| Race/Ethnicity, Customized Race Native American | 2 Participants | 5 Participants | 3 Participants |
| Race/Ethnicity, Customized Race Unknown or Missing | 3 Participants | 5 Participants | 2 Participants |
| Region of Enrollment United States | 115 Participants | 234 Participants | 119 Participants |
| Sex: Female, Male Female | 14 Participants | 23 Participants | 9 Participants |
| Sex: Female, Male Male | 101 Participants | 211 Participants | 110 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 115 | 0 / 119 |
| other Total, other adverse events | 1 / 115 | 0 / 119 |
| serious Total, serious adverse events | 0 / 115 | 1 / 119 |
Outcome results
Primary
Clinician Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS-5 is a 30-item clinical interview that assesses the 20 DSM-5 PTSD symptoms. Scores on the CAPS-5 can range from 0 to 80, with higher scores reflecting worse PTSD symptom severity. In this study, clinician-rated PTSD symptom severity were based on blind assessor ratings.
Time frame: Baseline
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinician-Supported PTSD Coach | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 28.52 score on a scale | Standard Error 0.97 |
| Primary Care Mental Health Integrated Care as Usual | Clinician Administered PTSD Scale for DSM-5 (CAPS-5) | 30.01 score on a scale | Standard Error 0.95 |
Primary
Hospital Administrative Data Showing 2 Mental Health Visits Completed
Hospital administrative data will be examined to determine if the participant completed 2 visits to any specialty mental health clinic during the follow-up period.
Time frame: 16 and 24 weeks
Population: For this outcome, only participants continuing to report significant PTSD symptoms (i.e., at or above the PCL-5 clinical cut score of 33) at 8 weeks were included. Per the protocol, these participants were offered a referral to specialty mental health treatment for PTSD.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Clinician-Supported PTSD Coach | Hospital Administrative Data Showing 2 Mental Health Visits Completed | 21 Participants |
| Primary Care Mental Health Integrated Care as Usual | Hospital Administrative Data Showing 2 Mental Health Visits Completed | 20 Participants |
Secondary
Client Satisfaction Questionnaire (CSQ)
The CSQ is a widely used 8-item self-report measure assessing patient satisfaction with care. Scores can range from 8 to 32 with higher scores reflecting greater satisfaction.
Time frame: 8 week
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Clinician-Supported PTSD Coach | Client Satisfaction Questionnaire (CSQ) | 27.10 score on a scale | Standard Deviation 3.73 |
| Primary Care Mental Health Integrated Care as Usual | Client Satisfaction Questionnaire (CSQ) | 24.60 score on a scale | Standard Deviation 4.82 |
Secondary
Patient Health Questionnaire (PHQ-9)
A 9-item self-report instrument used to assess depression severity. Items are scored 0 to 3, with the total score being the sum of the 9 items which can range from 0 as the minimum value to 27 as the maximum value. Higher scores indicate greater depression severity, with a score of 10 or greater indicating probable major depression, and scores of 20 or more severe major depression.
Time frame: Baseline, 8 week, 16 week, 24 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinician-Supported PTSD Coach | Patient Health Questionnaire (PHQ-9) | Baseline | 12.51 score on a scale | Standard Error 0.48 |
| Clinician-Supported PTSD Coach | Patient Health Questionnaire (PHQ-9) | 8-week | 11.03 score on a scale | Standard Error 0.5 |
| Clinician-Supported PTSD Coach | Patient Health Questionnaire (PHQ-9) | 16-week | 10.79 score on a scale | Standard Error 0.55 |
| Clinician-Supported PTSD Coach | Patient Health Questionnaire (PHQ-9) | 24-week | 10.22 score on a scale | Standard Error 0.61 |
| Primary Care Mental Health Integrated Care as Usual | Patient Health Questionnaire (PHQ-9) | 24-week | 11.30 score on a scale | Standard Error 0.57 |
| Primary Care Mental Health Integrated Care as Usual | Patient Health Questionnaire (PHQ-9) | Baseline | 13.63 score on a scale | Standard Error 0.47 |
| Primary Care Mental Health Integrated Care as Usual | Patient Health Questionnaire (PHQ-9) | 16-week | 11.80 score on a scale | Standard Error 0.52 |
| Primary Care Mental Health Integrated Care as Usual | Patient Health Questionnaire (PHQ-9) | 8-week | 12.12 score on a scale | Standard Error 0.48 |
Secondary
PTSD Checklist-5 (PCL-5)
The PCL-5 is a 20-item self-report measure assessing how much respondents have been bothered by DSM-5 PTSD symptoms in the past month. Scores can range from 0 to 80 with higher scores reflecting worse PTSD symptom severity.
Time frame: Baseline, 8 week, 16 week, 24 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinician-Supported PTSD Coach | PTSD Checklist-5 (PCL-5) | Baseline | 46.30 score on a scale | Standard Error 1.05 |
| Clinician-Supported PTSD Coach | PTSD Checklist-5 (PCL-5) | 8-week | 36.34 score on a scale | Standard Error 1.2 |
| Clinician-Supported PTSD Coach | PTSD Checklist-5 (PCL-5) | 16-week | 35.42 score on a scale | Standard Error 1.43 |
| Clinician-Supported PTSD Coach | PTSD Checklist-5 (PCL-5) | 24-week | 34.61 score on a scale | Standard Error 1.69 |
| Primary Care Mental Health Integrated Care as Usual | PTSD Checklist-5 (PCL-5) | 24-week | 38.05 score on a scale | Standard Error 1.58 |
| Primary Care Mental Health Integrated Care as Usual | PTSD Checklist-5 (PCL-5) | Baseline | 47.18 score on a scale | Standard Error 1.03 |
| Primary Care Mental Health Integrated Care as Usual | PTSD Checklist-5 (PCL-5) | 16-week | 38.99 score on a scale | Standard Error 1.35 |
| Primary Care Mental Health Integrated Care as Usual | PTSD Checklist-5 (PCL-5) | 8-week | 40.68 score on a scale | Standard Error 1.15 |
Secondary
WHOQOL-BREF Psychological Health Subscale
The psychological health (6 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-30 with higher scores reflecting better quality of life.
Time frame: Baseline, 8 week, 16 week, 24 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinician-Supported PTSD Coach | WHOQOL-BREF Psychological Health Subscale | Baseline Psych Subscale | 17.82 score on a scale | Standard Error 0.35 |
| Clinician-Supported PTSD Coach | WHOQOL-BREF Psychological Health Subscale | 8-week Psych Subscale | 18.16 score on a scale | Standard Error 0.37 |
| Clinician-Supported PTSD Coach | WHOQOL-BREF Psychological Health Subscale | 16-week Psych Subscale | 18.04 score on a scale | Standard Error 0.39 |
| Clinician-Supported PTSD Coach | WHOQOL-BREF Psychological Health Subscale | 24-week Psych Subscale | 18.29 score on a scale | Standard Error 0.42 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Psychological Health Subscale | 24-week Psych Subscale | 17.47 score on a scale | Standard Error 0.4 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Psychological Health Subscale | Baseline Psych Subscale | 17.51 score on a scale | Standard Error 0.34 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Psychological Health Subscale | 16-week Psych Subscale | 17.65 score on a scale | Standard Error 0.37 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Psychological Health Subscale | 8-week Psych Subscale | 17.50 score on a scale | Standard Error 0.35 |
Secondary
WHOQOL-BREF Social Relationships Subscale
The social relationships (3 items) subscale of the WHOQOL-BREF was used to assess the broader effects of the intervention on quality of life. Scores on this subscales range from 0-15 with higher scores reflecting better quality of life.
Time frame: Baseline, 8 week, 16 week, 24 week
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Clinician-Supported PTSD Coach | WHOQOL-BREF Social Relationships Subscale | 8-week Social Subscale | 9.31 score on a scale | Standard Error 0.24 |
| Clinician-Supported PTSD Coach | WHOQOL-BREF Social Relationships Subscale | Baseline Social Subscale | 8.88 score on a scale | Standard Error 0.24 |
| Clinician-Supported PTSD Coach | WHOQOL-BREF Social Relationships Subscale | 16-week Social Subscale | 9.23 score on a scale | Standard Error 0.26 |
| Clinician-Supported PTSD Coach | WHOQOL-BREF Social Relationships Subscale | 24-week Social Subscale | 9.01 score on a scale | Standard Error 0.27 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Social Relationships Subscale | 24-week Social Subscale | 8.40 score on a scale | Standard Error 0.25 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Social Relationships Subscale | 16-week Social Subscale | 8.58 score on a scale | Standard Error 0.24 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Social Relationships Subscale | Baseline Social Subscale | 8.56 score on a scale | Standard Error 0.23 |
| Primary Care Mental Health Integrated Care as Usual | WHOQOL-BREF Social Relationships Subscale | 8-week Social Subscale | 8.71 score on a scale | Standard Error 0.23 |