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

Sponsor
University of South Florida (Other)
Overall Status
Unknown status
CT.gov ID
NCT04121884
Collaborator
(none)
40
Enrollment
1
Location
1
Arm
10
Anticipated Duration (Months)
4
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or DiseaseIntervention/TreatmentPhase
  • Behavioral: Accelerated Resolution Therapy
N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
A prospective, longitudinal, descriptive study design.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 :
Nov 1, 2019
Anticipated Primary Completion Date :
Apr 30, 2020
Anticipated Study Completion Date :
Aug 31, 2020

Arms and Interventions

ArmIntervention/Treatment
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 Names:
  • ART
  • Outcome Measures

    Primary Outcome Measures

    1. Change in Autonomic Nervous System (ANS) Imbalance [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

    Secondary Outcome Measures

    1. Changes in ANS During ART [During first ART session at 1 week and during 4th ART session at 5 weeks]

      HRV and EEG power spectral densities

    Other Outcome Measures

    1. Degree of concordance between ART-induced changes in ANS and symptoms of PTSD, depression, ASD, complicated grief, and alcohol abuse [Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks]

      DSM-V PTSD Checklist (PCL-V)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Posttraumatic Stress Disorder (PTSD): Score of > 33 on the 20-item DSM-V PTSD Checklist (PCL-V) or

    • Depression: Score of > 16 on the 20-item Center for Epidemiologic Depression Scale or

    • Acute stress disorder: Presence of criterions A-E on the 19-item Acute Stress Disorder Scale or

    • Complicated grief: Score of > 25 on the 19-item Inventory of Complicated Grief or

    • Alcohol abuse: Score of > 10 on 10-item Alcohol Use Disorders Identification Test (AUDIT) and

    • Corroboration of the above symptomatology through verification of the corresponding subscale of the 125-item Psychiatric Diagnostic Screening Questionnaire (PDSQ).

    Exclusion Criteria:
    • Currently engaged in another psychotherapy regimen including currently engaged in ART or another eye movement therapy, such as EMDR;

    • Have a major psychiatric disorder (e.g. bipolar disorder) deemed likely to interfere with treatment delivery;

    • Currently in a formal substance dependence treatment program (alcohol and/or drug) anticipated to interfere with treatment delivery (e.g. through detox and symptoms of physiological withdrawal). All persons recruited for potential study participation will undergo a clinical intake assessment, with completion of ART intake form, by a licensed clinical therapist, to determine study eligibility.

    Contacts and Locations

    Locations

    SiteCityStateCountryPostal Code
    1University of South FloridaTampaFloridaUnited States33612

    Sponsors and Collaborators

    • University of South Florida

    Investigators

    • Principal Investigator: Kevin E Kip, PhD, University of South Florida
    • Principal Investigator: Paula L Cairns, PhD, University of South Florida

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Kevin Kip, Professor, University of South Florida
    ClinicalTrials.gov Identifier:
    NCT04121884
    Other Study ID Numbers:
    • Pro00040159
    First Posted:
    Oct 10, 2019
    Last Update Posted:
    Nov 4, 2019
    Last Verified:
    Nov 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kevin Kip, Professor, University of South Florida
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Nov 4, 2019