Clinical trial NCT04471207: Clinical Trial Intelligent Biometrics for PTSD - Clinical Trial
Official title: Intelligent Biometrics to Optimize Prolonged Exposure for PTSD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: PTSD
Keywords: PTSD
Military
Veterans
Lead sponsor: Medical University of South Carolina
Sponsor class: OTHER
Collaborators: name: Zeriscope
First posted: 2020-07-15
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Exclusion Criteria:

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.

Primary outcomes:
measure: Post Traumatic Stress Disorder Symptom Severity - Clinician Rated
timeFrame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
measure: Post Traumatic Stress Disorder Symptom Severity - Self Report
timeFrame: End of treatment (after 10-12 sessions of prolonged exposure). Participants had 24 weeks to complete treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
Study officials:
References:
citation: 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.