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Trial record 3 of 7 for:    accelerated resolution therapy

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
Sponsor:
Information provided by (Responsible Party):
Kevin Kip, University of South Florida

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 disease Intervention/treatment Phase
Depressive Symptoms Stress Disorder, Acute Prolonged Grief Disorder Alcohol Abuse Stress Disorders, Post-Traumatic Behavioral: Accelerated Resolution Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: N/A
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

Arm Intervention/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 Name: ART




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Paula L Cairns, PhD 8139749716 paulacairns@usf.edu
Contact: Kevin E Kip, PhD 8139749266 kkip@usf.edu

Locations
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United States, Florida
University of South Florida Recruiting
Tampa, Florida, United States, 33612
Contact: Paula L Cairns, PhD    727-543-8680    paulacairns@usf.edu   
Contact: Kevin E Kip, PhD    8139749266    kkip@usf.edu   
Sponsors and Collaborators
University of South Florida
Investigators
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Principal Investigator: Kevin E Kip, PhD University of South Florida
Principal Investigator: Paula L Cairns, PhD University of South Florida
Publications:

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Responsible Party: Kevin Kip, Professor, University of South Florida
ClinicalTrials.gov Identifier: NCT04121884    
Other Study ID Numbers: Pro00040159
First Posted: October 10, 2019    Key Record Dates
Last Update Posted: November 4, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Kevin Kip, University of South Florida:
Heart Rate Variability
Sleep
Electrocardiogram
Electroencephlogram
Alcohol Abuse
Prolonged Grief Disorder
Stress Disorder, Acute
Stress Disorders, Post-Traumatic
Depressive Symptoms
Power Spectral Density
Additional relevant MeSH terms:
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Disease
Alcoholism
Stress Disorders, Traumatic
Depression
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic, Acute
Pathologic Processes
Trauma and Stressor Related Disorders
Mental Disorders
Behavioral Symptoms
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders