Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART) (M-ART)
Primary Purpose
Depressive Symptoms, Stress Disorder, Acute, Prolonged Grief Disorder
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerated Resolution Therapy
Sponsored by
About this trial
This is an interventional basic science trial for Depressive Symptoms focused on measuring Heart Rate Variability, Sleep, Electrocardiogram, Electroencephlogram, Alcohol Abuse, Prolonged Grief Disorder, Stress Disorder, Acute, Stress Disorders, Post-Traumatic, Depressive Symptoms, Power Spectral Density
Eligibility 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.
Sites / Locations
- University of South FloridaRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
ART Treatment
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Autonomic Nervous System (ANS) Imbalance
HRV, EEG power spectral densities, and sleep architecture
Secondary Outcome Measures
Changes in ANS During ART
HRV and EEG power spectral densities
Full Information
NCT ID
NCT04121884
First Posted
October 7, 2019
Last Updated
November 1, 2019
Sponsor
University of South Florida
1. Study Identification
Unique Protocol Identification Number
NCT04121884
Brief Title
Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
Acronym
M-ART
Official Title
Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
April 30, 2020 (Anticipated)
Study Completion Date
August 31, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of South Florida
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depressive Symptoms, Stress Disorder, Acute, Prolonged Grief Disorder, Alcohol Abuse, Stress Disorders, Post-Traumatic
Keywords
Heart Rate Variability, Sleep, Electrocardiogram, Electroencephlogram, Alcohol Abuse, Prolonged Grief Disorder, Stress Disorder, Acute, Stress Disorders, Post-Traumatic, Depressive Symptoms, Power Spectral Density
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, longitudinal, descriptive study design.
Masking
None (Open Label)
Allocation
N/A
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ART Treatment
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Accelerated Resolution Therapy
Other Intervention Name(s)
ART
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Autonomic Nervous System (ANS) Imbalance
Description
HRV, EEG power spectral densities, and sleep architecture
Time Frame
Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks
Secondary Outcome Measure Information:
Title
Changes in ANS During ART
Description
HRV and EEG power spectral densities
Time Frame
During first ART session at 1 week and during 4th ART session at 5 weeks
Other Pre-specified Outcome Measures:
Title
Degree of concordance between ART-induced changes in ANS and symptoms of PTSD, depression, ASD, complicated grief, and alcohol abuse
Description
DSM-V PTSD Checklist (PCL-V)
Time Frame
Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paula L Cairns, PhD
Phone
8139749716
Email
paulacairns@usf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Kevin E Kip, PhD
Phone
8139749266
Email
kkip@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kevin E Kip, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paula L Cairns, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paula L Cairns, PhD
Phone
727-543-8680
Email
paulacairns@usf.edu
First Name & Middle Initial & Last Name & Degree
Kevin E Kip, PhD
Phone
8139749266
Email
kkip@usf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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23482431
Citation
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Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
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