PTSD
Conditions
Keywords
PTSD, Military, Veterans
Brief summary
Posttraumatic stress disorder (PTSD) is a debilitating mental health condition that increases suicide risk and affects up to 20% of military veterans and 8% of the general population. Prolonged Exposure (PE) is a highly effective behavioral (talk therapy) intervention for PTSD. However, dropout rates are high (25-30%) and an estimated one-third of patients who complete PE still report symptoms of PTSD at the end of treatment. This study directly addresses these limitations by using a clinical trial to evaluate the ability of an innovative technology system to improve PE therapy for veterans with PTSD.
Detailed description
Posttraumatic stress disorder (PTSD) is a chronic and debilitating psychiatric condition. Prolonged Exposure (PE) therapy is a highly effective, evidence-based treatment for PTSD; however, dropout rates are high and approximately one-third of patients who complete treatment remain symptomatic. The proposed study will employ a randomized clinical trial (N=40 treatment-seeking veterans with current PTSD) to evaluate the acceptability, feasibility and preliminary efficacy of a technological enhancement (IB-PE), and investigate predictors of outcome by accomplishing the following milestones: (1a) Evaluate ability of IB-PE (therapist guided vs. record only) in reducing PTSD severity from baseline to end of treatment; and (2b) Use a variety of in vivo exposures (IVEs) to identify biometric and behavioral indicators (high heart rate, skin conductance) with high predictive value of treatment response. We will use a technology system of discrete wearables (camera, microphone) to allow therapists to accompany participants during IVEs. The system will pair with a cellular application and record information such as heart rate and skin conductance. This system will also allow the participant to communicate with the study therapist during the guided in vivo exercises.
Interventions
DEVICETherapist Guided Prolonged Exposure with BioWare Device
Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists will use actionable data during in vivo exposures (IVEs) (galvanic skin response \[GSR\], heart rate \[HR\], and subjective units of distress \[SUDS\]) to modify the assignments in real-time. All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
DEVICERecord Only Prolonged Exposure with BioWare Device
In the record-only group, passive data collection will be utilized to collect and store biometric and behavioral data for future offline analyses to investigate predictors of outcome. All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
Sponsors
Zeriscope
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female; any race or ethnicity; aged 18-75 years. 2. U.S. Military veteran, any branch or era. 3. Participants must be able to comprehend English. 4. Participants must meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) diagnostic criteria for current (i.e., past 6 months) posttraumatic stress disorder (PTSD) (assessed via the Clinician Administered PTSD Scale for DSM-5). Subjects may also meet criteria for a mood disorder (except bipolar affective disorder, see
Exclusion criteria
) or anxiety disorders (panic disorder, agoraphobia, social phobia, generalized anxiety disorder, or obsessive compulsive disorder). The inclusion of subjects with affective and other anxiety disorders is essential because of the marked frequency of the co-existence of mood and other anxiety disorders among patients with PTSD. 5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post Traumatic Stress Disorder Symptom Severity - Clinician Rated | End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment. | Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered assessment for posttraumatic stress symptoms. The assessment is administered at baseline, mid treatment and end of treatment. The CAPS-5 is a 30 item assessment that assesses 20 symptoms of PTSD, with scores ranging from 0-80. Lower scores represent fewer and less sever symptoms of PTSD. |
| Post Traumatic Stress Disorder Symptom Severity - Self Report | End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment. | Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) is a twenty item assessment for self-reported symptoms of posttraumatic stress symptoms. Assessment was administered at baseline, and weekly through the end of treatment. Each of the twenty items has a score of 0-4. Lower scores represent fewer posttraumatic stress symptoms. Scores range from 0 to 80. |
Countries
United States
Participant flow
Recruitment details
All participants were recruited via online advertisements and clinician referrals. Participants were seen via telehealth due to the coronavirus-2 pandemic (SARS-Cov-2). Of note, the study initially focused on military veterans because of their high levels of posttraumatic stress disorder. However, due to the SARS-Cov-2 pandemic which impacted recruitment goals, the inclusion criteria were expanded to include both civilians and veterans.
Pre-assignment details
A total of 40 participants were randomized in a 3:1 fashion (Guided, n = 29; Non-Guided, n = 11). One participant was removed from the Non-Guided group due to a medical contraindication, and thus the intent-to-treat (ITT) sample consisted of N = 39 individuals. A total of n = 23 individuals completed at least eight sessions of prolonged exposure therapy and used the BioWare system at least one time and represents the treatment completers or per protocol (PP) sample.
Participants by arm
| Arm | Count |
|---|---|
| Intelligent Biometrics - Prolonged Exposure (Therapist Guided). Therapist Guided Prolonged Exposure with BioWare Device: Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist guided group, Study Therapists use actionable biometric and subjective data during in-vivo exposures (IVEs) (e.g., heart rate and subjective units of distress) to modify the assignments in real-time.
All participants receive prolonged exposure therapy for posttraumatic stress disorder. | 29 |
| Intelligent Biometrics - Prolonged Exposure (Record Only). Record Only Prolonged Exposure with BioWare Device: In the record-only group, passive data collection will be utilized to collect and store biometric and behavioral data for future offline analyses to investigate predictors of outcome.
All participants receive prolonged exposure therapy for posttraumatic stress disorder. | 10 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Loss of Interest | 2 | 1 |
| Overall Study | Lost to Follow-up | 4 | 1 |
| Overall Study | Medication Contraindication | 0 | 1 |
| Overall Study | Physician Decision | 1 | 0 |
| Overall Study | Scheduling Conflicts | 3 | 1 |
| Overall Study | Unwilling to Discuss Trauma | 1 | 1 |
| Overall Study | Unwilling to Use System | 0 | 1 |
Baseline characteristics
| Characteristic | Intelligent Biometrics - Prolonged Exposure (Record Only). | Total | Intelligent Biometrics - Prolonged Exposure (Therapist Guided). |
|---|---|---|---|
| Age, Continuous | 48.10 years STANDARD_DEVIATION 13.05 | 45.31 years STANDARD_DEVIATION 14.77 | 44.34 years STANDARD_DEVIATION 15.41 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 3 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 36 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 8 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 4 Participants | 4 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 | 7 Participants | 27 Participants | 20 Participants |
| Sex: Female, Male Female | 3 Participants | 18 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 21 Participants | 14 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 29 | 0 / 11 |
| other Total, other adverse events | 10 / 29 | 3 / 11 |
| serious Total, serious adverse events | 1 / 29 | 2 / 11 |
Outcome results
Primary
Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
Clinician Administered Posttraumatic Stress Disorder (PTSD) Scale (CAPS-5) is a clinician administered assessment for posttraumatic stress symptoms. The assessment is administered at baseline, mid treatment and end of treatment. The CAPS-5 is a 30 item assessment that assesses 20 symptoms of PTSD, with scores ranging from 0-80. Lower scores represent fewer and less sever symptoms of PTSD.
Time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
Population: Analysis on treatment completers (completion of at least eight sessions of prolonged exposure and use of BioWare device at least one time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intelligent Biometrics - Prolonged Exposure (Therapist Guided). | Post Traumatic Stress Disorder Symptom Severity - Clinician Rated | 25.71 units on a scale | Standard Deviation 14.65 |
| Intelligent Biometrics - Prolonged Exposure (Record Only). | Post Traumatic Stress Disorder Symptom Severity - Clinician Rated | 32.00 units on a scale | Standard Deviation 11.64 |
Primary
Post Traumatic Stress Disorder Symptom Severity - Self Report
Posttraumatic Checklist for Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (PCL-5) is a twenty item assessment for self-reported symptoms of posttraumatic stress symptoms. Assessment was administered at baseline, and weekly through the end of treatment. Each of the twenty items has a score of 0-4. Lower scores represent fewer posttraumatic stress symptoms. Scores range from 0 to 80.
Time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
Population: Analysis on treatment completers (completion of at least eight sessions of prolonged exposure and use of Bio Ware device at least one time.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intelligent Biometrics - Prolonged Exposure (Therapist Guided). | Post Traumatic Stress Disorder Symptom Severity - Self Report | 27.11 units on a scale | Standard Deviation 18.56 |
| Intelligent Biometrics - Prolonged Exposure (Record Only). | Post Traumatic Stress Disorder Symptom Severity - Self Report | 50.80 units on a scale | Standard Deviation 17.34 |