Trial Outcomes & Findings for Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial (NCT NCT04471207)
NCT ID: NCT04471207
Last Updated: 2023-10-31
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
40 participants
Primary outcome timeframe
End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
Results posted on
2023-10-31
Participant Flow
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.
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.
Participant milestones
| Measure |
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) (heart rate and subjective units of distress) to modify the assignments in real-time.
All participants receive prolonged exposure therapy for posttraumatic stress disorder.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
11
|
|
Overall Study
COMPLETED
|
18
|
5
|
|
Overall Study
NOT COMPLETED
|
11
|
6
|
Reasons for withdrawal
| Measure |
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) (heart rate and subjective units of distress) to modify the assignments in real-time.
All participants receive prolonged exposure therapy for posttraumatic stress disorder.
|
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.
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
4
|
1
|
|
Overall Study
Medication Contraindication
|
0
|
1
|
|
Overall Study
Loss of Interest
|
2
|
1
|
|
Overall Study
Unwilling to Discuss Trauma
|
1
|
1
|
|
Overall Study
Scheduling Conflicts
|
3
|
1
|
|
Overall Study
Physician Decision
|
1
|
0
|
|
Overall Study
Unwilling to Use System
|
0
|
1
|
Baseline Characteristics
Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Baseline characteristics by cohort
| Measure |
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
n=29 Participants
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.
|
Intelligent Biometrics - Prolonged Exposure (Record Only).
n=10 Participants
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.
|
Total
n=39 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
44.34 years
STANDARD_DEVIATION 15.41 • n=5 Participants
|
48.10 years
STANDARD_DEVIATION 13.05 • n=7 Participants
|
45.31 years
STANDARD_DEVIATION 14.77 • n=5 Participants
|
|
Sex: Female, Male
Female
|
15 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
36 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
n=18 Participants
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.
|
Intelligent Biometrics - Prolonged Exposure (Record Only).
n=5 Participants
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.
|
|---|---|---|
|
Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
|
25.71 units on a scale
Standard Deviation 14.65
|
32.00 units on a scale
Standard Deviation 11.64
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
n=18 Participants
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.
|
Intelligent Biometrics - Prolonged Exposure (Record Only).
n=5 Participants
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.
|
|---|---|---|
|
Post Traumatic Stress Disorder Symptom Severity - Self Report
|
27.11 units on a scale
Standard Deviation 18.56
|
50.80 units on a scale
Standard Deviation 17.34
|
Adverse Events
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Intelligent Biometrics - Prolonged Exposure (Record Only).
Serious events: 2 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
n=29 participants at risk
Therapist Guided Prolonged Exposure with BioWare Device: Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist-guided group, Study Therapists will virtually accompany patients during in vivo exposures (IVEs) and use actionable biometric and subjective data during IVEs (galvanic skin response \[GSR, subjective units of distress \[SUDS\], and heart rate \[HR) to modify the assignments in real-time.
All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
|
Intelligent Biometrics - Prolonged Exposure (Record Only).
n=11 participants at risk
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 at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
|
|---|---|---|
|
Blood and lymphatic system disorders
Intestinal Lymphangiectasia
|
0.00%
0/29 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Spinal Injury
|
3.4%
1/29 • Number of events 1 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
0.00%
0/11 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Nervous system disorders
Transient Ischemic
|
0.00%
0/29 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
Other adverse events
| Measure |
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
n=29 participants at risk
Therapist Guided Prolonged Exposure with BioWare Device: Experimental: Intelligent Biometrics - Prolonged Exposure (therapist guided). In the therapist-guided group, Study Therapists will virtually accompany patients during in vivo exposures (IVEs) and use actionable biometric and subjective data during IVEs (galvanic skin response \[GSR, subjective units of distress \[SUDS\], and heart rate \[HR) to modify the assignments in real-time.
All participants receive at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
|
Intelligent Biometrics - Prolonged Exposure (Record Only).
n=11 participants at risk
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 at least 10 sessions of prolonged exposure therapy for posttraumatic stress disorder.
|
|---|---|---|
|
Nervous system disorders
Headache or Migraine
|
17.2%
5/29 • Number of events 6 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
0.00%
0/11 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Infections and infestations
Cough
|
13.8%
4/29 • Number of events 4 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
0.00%
0/11 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Gastrointestinal disorders
Gastrointestinal Discomfort
|
10.3%
3/29 • Number of events 6 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
18.2%
2/11 • Number of events 2 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Infections and infestations
Sinusitis
|
6.9%
2/29 • Number of events 2 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
9.1%
1/11 • Number of events 1 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Infections and infestations
Fever
|
10.3%
3/29 • Number of events 3 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
0.00%
0/11 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
|
Musculoskeletal and connective tissue disorders
Pain in Lower Extremities
|
10.3%
3/29 • Number of events 6 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
27.3%
3/11 • Number of events 3 • Adverse events were collected from baseline through follow up, approximately 4 months.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place