Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART) (M-ART)
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|ClinicalTrials.gov Identifier: NCT04121884|
Recruitment Status : Recruiting
First Posted : October 10, 2019
Last Update Posted : November 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Depressive Symptoms Stress Disorder, Acute Prolonged Grief Disorder Alcohol Abuse Stress Disorders, Post-Traumatic||Behavioral: Accelerated Resolution Therapy||Not Applicable|
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:
- 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).
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||A prospective, longitudinal, descriptive study design.|
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)|
|Actual Study Start Date :||November 1, 2019|
|Estimated Primary Completion Date :||April 30, 2020|
|Estimated Study Completion Date :||August 31, 2020|
Experimental: ART Treatment
A broad patient representation of male and female adults; aged > 18 years; English speaking; and significant clinical symptoms of any of the following conditions: PTSD, Depression, ASD, Complicated Grief, and Alcohol Abuse.
Behavioral: Accelerated Resolution Therapy
The ART protocol first uses the technique of imaginal exposure to elicit physiological reactions associated with patient recall from beginning to end (verbally or non-verbally) of a traumatic/distressing experience. As physiological reactions emerge, the participant is directed to focus their attention on the specific body-centric reactions while laterally performing smooth pursuit eye movements which are achieved by tracking the clinician's hand which oscillates from left-to-right at a short distance from the participant's eyes. Then the participant is directed to imagine a positive way in which they prefer to recall their experience(s), including emphasis on "replacing" negative images in the brain with positive images. This technique is based on the process of memory reconsolidation, which allows for "adding" of positive material to the recall of negative, highly emotional past experiences.
Other Name: ART
- Change in Autonomic Nervous System (ANS) Imbalance [ Time Frame: Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks ]HRV, EEG power spectral densities, and sleep architecture
- Changes in ANS During ART [ Time Frame: During first ART session at 1 week and during 4th ART session at 5 weeks ]HRV and EEG power spectral densities
- Degree of concordance between ART-induced changes in ANS and symptoms of PTSD, depression, ASD, complicated grief, and alcohol abuse [ Time Frame: Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks ]DSM-V PTSD Checklist (PCL-V)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121884
|Contact: Paula L Cairns, PhDemail@example.com|
|Contact: Kevin E Kip, PhDfirstname.lastname@example.org|
|Principal Investigator:||Kevin E Kip, PhD||University of South Florida|
|Principal Investigator:||Paula L Cairns, PhD||University of South Florida|