Clinical Trial Intelligent Biometrics for PTSD

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-08

Study Completion Date

2022-03-08

Brief Summary

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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.

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Detailed Description

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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

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PTSD

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Intelligent Biometrics - Prolonged Exposure (Therapist Guided).

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.

Group Type EXPERIMENTAL

Therapist Guided Prolonged Exposure with BioWare Device

Intervention Type 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.

Intelligent Biometrics - Prolonged Exposure (Record Only).

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.

Group Type ACTIVE_COMPARATOR

Record Only Prolonged Exposure with BioWare Device

Intervention Type 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.

Interventions

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Therapist 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.

Intervention Type DEVICE

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.

Intervention Type DEVICE

Eligibility Criteria

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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.

Exclusion Criteria

5. Participants taking psychotropic medications will be required to be maintained on a stable dose for at least four weeks before study initiation.

1. 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.
2. 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.
3. 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.
4. Participants on maintenance anxiolytic, antidepressant, or mood stabilizing medications, which have been initiated during the past 4 weeks.
5. 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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No