Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART) — M-ART  

Depressive Symptoms Clinical Trial

Official title: Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)

Status Recruiting

Clinical Trial Summary

In brief, ART is an innovative "mind-body" (body-centric) psychotherapy that makes use of established core components of trauma-focused therapy including imaginal exposure and imagery rescripting to promote memory reconsolidation, all facilitated as the patient is directed by the therapist to perform sets of lateral left-right eye movements similar to rapid eye movements (REM). The investigators propose to investigate how ART may directly influence heart rate variability (HRV), EEG power spectral densities, and sleep architecture in three aims. At the broadest level, the investigators postulate that both within individual ART sessions, and across the full course of treatment (e.g. up to 4 sessions), ART results in a profound shift from sympathetic (arousal) to parasympathetic (rest) nervous system balance, and that this shift can be reliably measured by neurophysiological assessment using electrocardiogram (ECG) and electroencephalogram (EEG) measurement.

Clinical Trial Description

Our long-term goal is to understand, from a mechanistic perspective, how ART appears to result in rapid, successful treatment of PTSD and related comorbidities. This knowledge will help to identify target populations for treatment, and objective approaches in which to evaluate patient outcome response beyond conventional reliance on self-report measures. Thus, specific aims of our proposal, which will make use of wireless equipment for Electrocardiographic (ECG) measurement of Heart Rate Variability (HRV), and Electroencephalographic (EEG) measurements of power spectral densities and sleep architecture, are as follows:

1. To quantify and characterize changes in HRV, EEG power spectral densities, sleep architecture, and ANS balance within individual sessions of ART, as well as before and at the end of treatment with ART (up to 4 sessions).

2. To examine whether the aforementioned ART-induced changes in HRV, EEG power spectral densities, sleep architecture, and ANS balance vary substantially in the setting of primary treatment for symptoms of post- traumatic stress disorder (PTSD), depression, acute stress disorder, complicated grief, and/or alcohol abuse.

3. To assess the degree of concordance between ART-induced objective measurement of changes in HRV, EEG power spectral densities, sleep architecture, and ANS balance and self-report changes in symptoms of PTSD, depression, acute stress disorder, complicated grief, and/or alcohol abuse.

The investigators will accomplish these objectives using a prospective, longitudinal, descriptive design to achieve robust results. Subjects (n=40) will be enrolled in the study based on symptomatology. All subjects will receive Accelerated Resolution Therapy (ART) on a weekly basis for up to 4 sessions. The dose of up to 4 sessions has been selected to insure what is believed to be an effective dose based on previous studies of ART for treatment of PTSD. The investigators will collect data pre, during, and post each ART session. The sample of 40 subjects will be drawn from referrals at private practices of designated licensed mental health clinicians certified in ART, referrals from stakeholders and academic and community partners (e.g. USF student veterans referred through the USF Office of Student Veterans), and referrals of immediate family members of an individual who received hospice care prior to death at Suncoast Hospice or Chapters Health System. All subjects will undergo an intake assessment by a licensed clinical psychologist to determine study eligibility at USF.

The investigators expect to obtain support for our central hypothesis that ART modulates neurophysiological mechanisms through neurophysiological biomarkers of the autonomic (parasympathetic) nervous system and improved sleep architecture. Knowledge from a mechanistic perspective, on how ART appears to result in rapid, successful treatment of symptoms of PTSD and related conditions will help to identify target populations for treatment, and objective approaches in which to evaluate patient outcome response beyond conventional reliance on self-report measures. ;

Related Conditions & MeSH terms

• Alcohol Abuse
• Alcoholism
• Depression
• Depressive Symptoms
• Disease
• Prolonged Grief Disorder
• Stress Disorder, Acute
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic
• Stress Disorders, Traumatic, Acute

• NCT number: NCT04121884
• Study type: Interventional
• Source: University of South Florida
• Contact: Paula L Cairns, PhD
• Phone: 8139749716
• Email: paulacairns@usf.edu
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2019
• Completion date: August 31, 2020