PTSDPhase 1NCT04471207

Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial

A Phase 1 study testing Therapist Guided Prolonged Exposure with BioWare Device and Record Only Prolonged Exposure with BioWare Device in people with PTSD, run by Medical University of South Carolina at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 to 75 years
Conditions the study is for: PTSD
What is being tested?: Therapist Guided Prolonged Exposure with BioWare Device and Record Only Prolonged Exposure with BioWare Device
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteUnited States
Study dates: 8 Jun 2020to 8 Mar 2022
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 75 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female; any race or ethnicity; aged 18-75 years.
U.S. Military veteran, any branch or era.
Participants must be able to comprehend English.
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.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation.

Who cannot join

Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders. Those participants will be referred clinically to ensure they have appropriate level of clinical care.
Participants meeting DSM-5 criteria for a current (past 6 months) moderate to severe substance use disorder. Those participants will be referred to addiction treatment centers at the Veterans Affairs, Medical University of South Carolina and in the local community. Individuals with mild substance use disorder (SUD) will be included.
Participants considered an immediate suicidal or homicidal risk or who are likely to require hospitalization during the course of the study for suicidality. Those participants will be referred clinically for care.
Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks.
Participants enrolled in ongoing evidence-based behavioral therapy for PTSD who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical University of South Carolina
Charleston, South Carolina, 29401

Other trials in United States

About this study

Official title: Intelligent Biometrics to Optimize Prolonged Exposure for PTSD

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.

Read the 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.

Conditions: PTSD
Being tested: Therapist Guided Prolonged Exposure with BioWare Device, Record Only Prolonged Exposure with BioWare Device
Keywords: PTSD, Military, Veterans
Medical subject headings: Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Therapist Guided Prolonged Exposure with BioWare DeviceDevice
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.
Record Only Prolonged Exposure with BioWare DeviceDevice
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.

Study groups in NCT04471207
Study group	Role	What they receive
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).	Experimental	In the therapist-guided group, Study Therapists will virtually accompany patients during IVEs and use actionable biometric and subjective 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. Receives: Device: Therapist Guided Prolonged Exposure with BioWare Device
Intelligent Biometrics - Prolonged Exposure (Record Only).	Active comparator	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. Receives: Device: Record Only Prolonged Exposure with BioWare Device

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
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.
Measured: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jun 20208 Mar 2022

First posted15 Jul 2020
Study start8 Jun 2020
Primary completion3 Feb 2022
Study completion8 Mar 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for PTSDStudies of the same condition, open and under way.
More trials run by Medical University of South CarolinaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04471207
Sponsor's protocol ID: 00094890
Status last verified: Oct 2023
First submitted: 14 Apr 2020
Last updated: 31 Oct 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No

Publications

Saraiya TC, Jarnecke AM, Rothbaum AO, Wangelin B, McTeague LM, Acierno R, Brown DG, Bristol E, Feigl H, Reese M, Cobb AR, Harley B, Adams RJ, Back SE. Technology-enhanced in vivo exposures in Prolonged Exposure for PTSD: A pilot randomized controlled trial. J Psychiatr Res. 2022 Dec;156:467-475. doi: 10.1016/j.jpsychires.2022.10.056. Epub 2022 Nov 1.
PubMed 36347106

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 31 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intelligent Biometrics to Optimize Prolonged Exposure for PTSD
ClinicalTrials.gov ID: NCT04471207
Acronym / sponsor ID: 00094890
Conditions: PTSD
Keywords: PTSD, Military, Veterans
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Medical University of South CarolinaUniversity, hospital or other
Collaborators: Zeriscope
Study start: 8 Jun 2020 (actual)
Primary completion: 3 Feb 2022 (actual)
Study completion: 8 Mar 2022 (actual)
First posted: 15 Jul 2020 (actual)
Results: Posted 31 Oct 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).	Experimental	Device: Therapist Guided Prolonged Exposure with BioWare DeviceIn the therapist-guided group, Study Therapists will virtually accompany patients during IVEs and use actionable biometric and subjective 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.
Intelligent Biometrics - Prolonged Exposure (Record Only).	Active comparator	Device: Record Only Prolonged Exposure with BioWare DeviceIn 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.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

Male or female; any race or ethnicity; aged 18-75 years.
U.S. Military veteran, any branch or era.
Participants must be able to comprehend English.
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.
Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation.

Key exclusion criteria (5 listed)

Participants meeting DSM-5 criteria for a history of or current psychotic or bipolar affective disorders. Those participants will be referred clinically to ensure they have appropriate level of clinical care.
Participants meeting DSM-5 criteria for a current (past 6 months) moderate to severe substance use disorder. Those participants will be referred to addiction treatment centers at the Veterans Affairs, Medical University of South Carolina and in the local community. Individuals with mild substance use disorder (SUD) will be included.
Participants considered an immediate suicidal or homicidal risk or who are likely to require hospitalization during the course of the study for suicidality. Those participants will be referred clinically for care.
Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks.
Participants enrolled in ongoing evidence-based behavioral therapy for PTSD who are not willing to discontinue these therapies for the duration of the trial. Attendance at therapeutic activities other than study sessions will be closely monitored using the Treatment Services Review.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Therapist Guided Prolonged Exposure with BioWare DeviceExperimental: 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.	Device	Intelligent Biometrics - Prolonged Exposure (Therapist Guided).
Record Only Prolonged Exposure with BioWare DeviceIn 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.	Device	Intelligent Biometrics - Prolonged Exposure (Record Only).

Primary outcome

Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
Time frame: 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
Time frame: 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.

Results and safety

Results posted to the registry on 31 Oct 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).	29	18
Intelligent Biometrics - Prolonged Exposure (Record Only).	11	5

Primary outcome: Post Traumatic Stress Disorder Symptom Severity - Clinician Rated

Time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.. Mean (Standard Deviation). Unit: units on a scale

Measure	Intelligent Biometrics - Prolonged Exposure (Therapist Guided). n = 18	Intelligent Biometrics - Prolonged Exposure (Record Only). n = 5
Value	25.71 (14.65)	32.00 (11.64)

Population analysed: Analysis on treatment completers (completion of at least eight sessions of prolonged exposure and use of BioWare device at least one time.

Primary outcome: Post Traumatic Stress Disorder Symptom Severity - Self Report

Time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.. Mean (Standard Deviation). Unit: units on a scale

Measure	Intelligent Biometrics - Prolonged Exposure (Therapist Guided). n = 18	Intelligent Biometrics - Prolonged Exposure (Record Only). n = 5
Value	27.11 (18.56)	50.80 (17.34)

Population analysed: Analysis on treatment completers (completion of at least eight sessions of prolonged exposure and use of Bio Ware device at least one time.

Adverse events

Time frame: Adverse events were collected from baseline through follow up, approximately 4 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Intelligent Biometrics - Prolonged Exposure (Therapist Guided).	1 of 29 (3.4%)	10 of 29 (34.5%)	0 of 29
Intelligent Biometrics - Prolonged Exposure (Record Only).	2 of 11 (18.2%)	3 of 11 (27.3%)	0 of 11

Limitations and caveats (from the sponsor): The sample size was small, particularly for the Non-Guided group due to the focus on gaining experience with the clinician-guided IVEs in the Guided group. Thus, power to detect some effects was low, and the findings should be considered preliminary. Guided group also received more attention than Non-Guided group through the delivery of clinician-guided IVEs. This study did not compare between self-guided IVEs with the device and self-guided IVEs without the device.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 36347106Saraiya TC, Jarnecke AM, Rothbaum AO, Wangelin B, McTeague LM, Acierno R, Brown DG, Bristol E, Feigl H, Reese M, Cobb AR, Harley B, Adams RJ, Back SE. Technology-enhanced in vivo exposures in Prolonged Exposure for PTSD: A pilot randomized controlled trial. J Psychiatr Res. 2022 Dec;156:467-475. doi: 10.1016/j.jpsychires.2022.10.056. Epub 2022 Nov 1.

Related trials for PTSD

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Oct 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post Traumatic Stress Disorder Symptom Severity - Clinician Rated (time frame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04471207, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2023.