Clinical trial NCT04121884: Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
Official title: Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: 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
Lead sponsor: University of South Florida
Sponsor class: OTHER
First posted: 2019-10-10
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, longitudinal, descriptive study design.
Primary purpose: BASIC_SCIENCE

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:

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.

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.

Primary outcomes:
measure: Change in Autonomic Nervous System (ANS) Imbalance
timeFrame: Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks
Secondary outcomes:
measure: Changes in ANS During ART
timeFrame: During first ART session at 1 week and during 4th ART session at 5 weeks
Other outcomes:
measure: Degree of concordance between ART-induced changes in ANS and symptoms of PTSD, depression, ASD, complicated grief, and alcohol abuse
timeFrame: Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Kevin E Kip, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Paula L Cairns, PhD
role: PRINCIPAL_INVESTIGATOR
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