Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)

NCT04121884 | Unknown

• 1 other identifier: Pro00040159
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• Change in Autonomic Nervous System (ANS) Imbalance

  HRV, EEG power spectral densities, and sleep architecture

  Baseline pre first ART session at study day 1 and post 4th ART session at 5 weeks

Secondary Outcomes (1)

• Changes in ANS During ART

  During first ART session at 1 week and during 4th ART session at 5 weeks

Other Outcomes (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

Study Arms (1)

ART Treatment

EXPERIMENTAL

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

Interventions

Accelerated Resolution Therapy BEHAVIORAL

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.

Also known as: ART

ART Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of South Florida: lead

Study Sites (1)

University of South Florida

Tampa, Florida, 33612, United States

RECRUITING

Related Publications (22)

• Kip KE, Sullivan KL, Lengacher CA, Rosenzweig L, Hernandez DF, Kadel R, Kozel FA, Shuman A, Girling SA, Hardwick MJ, Diamond DM. Brief treatment of co-occurring post-traumatic stress and depressive symptoms by use of accelerated resolution therapy((R)). Front Psychiatry. 2013 Mar 8;4:11. doi: 10.3389/fpsyt.2013.00011. eCollection 2013.

  PMID: 23482431 BACKGROUND

• Kip KE, Hernandez DF, Shuman A, Witt A, Diamond DM, Davis S, Kip R, Abhayakumar A, Wittenberg T, Girling SA, Witt S, Rosenzweig L. Comparison of Accelerated Resolution Therapy (ART) for Treatment of Symptoms of PTSD and Sexual Trauma Between Civilian and Military Adults. Mil Med. 2015 Sep;180(9):964-71. doi: 10.7205/MILMED-D-14-00307.

  PMID: 26327548 BACKGROUND

• Kip KE, Diamond DM. Clinical, Empirical, and Theoretical Rationale for Selection of Accelerated Resolution Therapy for Treatment of Post-traumatic Stress Disorder in VA and DoD Facilities. Mil Med. 2018 Sep 1;183(9-10):e314-e321. doi: 10.1093/milmed/usy027.

  PMID: 29635395 BACKGROUND

• Kip KE, D'Aoust RF, Hernandez DF, Girling SA, Cuttino B, Long MK, Rojas P, Wittenberg T, Abhayakumar A, Rosenzweig L. Evaluation of brief treatment of symptoms of psychological trauma among veterans residing in a homeless shelter by use of Accelerated Resolution Therapy. Nurs Outlook. 2016 Sep-Oct;64(5):411-23. doi: 10.1016/j.outlook.2016.04.006. Epub 2016 May 7.

  PMID: 27601310 BACKGROUND

• Kip KE, Shuman A, Hernandez DF, Diamond DM, Rosenzweig L. Case report and theoretical description of accelerated resolution therapy (ART) for military-related post-traumatic stress disorder. Mil Med. 2014 Jan;179(1):31-7. doi: 10.7205/MILMED-D-13-00229.

  PMID: 24402982 BACKGROUND

• Hernandez DF, Waits W, Calvio L, Byrne M. Practice comparisons between accelerated resolution therapy, eye movement desensitization and reprocessing and cognitive processing therapy with case examples. Nurse Educ Today. 2016 Dec;47:74-80. doi: 10.1016/j.nedt.2016.05.010. Epub 2016 May 21.

  PMID: 27250615 BACKGROUND

• Kip KE, Rosenzweig L, Hernandez DF, Shuman A, Diamond DM, Girling SA, Sullivan KL, Wittenberg T, Witt AM, Lengacher CA, Anderson B, McMillan SC. Accelerated Resolution Therapy for treatment of pain secondary to symptoms of combat-related posttraumatic stress disorder. Eur J Psychotraumatol. 2014 May 7;5. doi: 10.3402/ejpt.v5.24066. eCollection 2014.

  PMID: 24959325 BACKGROUND

• Schimmels J, Waits W. A Tale of Two Compulsions - Two Case Studies Using Accelerated Resolution Therapy (ART) for Obsessive Compulsive Disorder (OCD). Mil Med. 2019 May 1;184(5-6):e470-e474. doi: 10.1093/milmed/usy257.

  PMID: 30295890 BACKGROUND

• Blechert J, Michael T, Grossman P, Lajtman M, Wilhelm FH. Autonomic and respiratory characteristics of posttraumatic stress disorder and panic disorder. Psychosom Med. 2007 Dec;69(9):935-43. doi: 10.1097/PSY.0b013e31815a8f6b. Epub 2007 Nov 8.

  PMID: 17991823 BACKGROUND

• Chalmers JA, Quintana DS, Abbott MJ, Kemp AH. Anxiety Disorders are Associated with Reduced Heart Rate Variability: A Meta-Analysis. Front Psychiatry. 2014 Jul 11;5:80. doi: 10.3389/fpsyt.2014.00080. eCollection 2014.

  PMID: 25071612 BACKGROUND

• Thayer JF, Yamamoto SS, Brosschot JF. The relationship of autonomic imbalance, heart rate variability and cardiovascular disease risk factors. Int J Cardiol. 2010 May 28;141(2):122-31. doi: 10.1016/j.ijcard.2009.09.543. Epub 2009 Nov 11.

  PMID: 19910061 BACKGROUND

• Thayer JF, Ahs F, Fredrikson M, Sollers JJ 3rd, Wager TD. A meta-analysis of heart rate variability and neuroimaging studies: implications for heart rate variability as a marker of stress and health. Neurosci Biobehav Rev. 2012 Feb;36(2):747-56. doi: 10.1016/j.neubiorev.2011.11.009. Epub 2011 Dec 8.

  PMID: 22178086 BACKGROUND

• Kemp AH, Griffiths K, Felmingham KL, Shankman SA, Drinkenburg W, Arns M, Clark CR, Bryant RA. Disorder specificity despite comorbidity: resting EEG alpha asymmetry in major depressive disorder and post-traumatic stress disorder. Biol Psychol. 2010 Oct;85(2):350-4. doi: 10.1016/j.biopsycho.2010.08.001. Epub 2010 Aug 11.

  PMID: 20708650 BACKGROUND

• Lobo I, Portugal LC, Figueira I, Volchan E, David I, Garcia Pereira M, de Oliveira L. EEG correlates of the severity of posttraumatic stress symptoms: A systematic review of the dimensional PTSD literature. J Affect Disord. 2015 Sep 1;183:210-20. doi: 10.1016/j.jad.2015.05.015. Epub 2015 May 15.

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• Todder D, Levine J, Abujumah A, Mater M, Cohen H, Kaplan Z. The quantitative electroencephalogram and the low-resolution electrical tomographic analysis in posttraumatic stress disorder. Clin EEG Neurosci. 2012 Jan;43(1):48-53. doi: 10.1177/1550059411428716.

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• Metzger LJ, Paige SR, Carson MA, Lasko NB, Paulus LA, Pitman RK, Orr SP. PTSD arousal and depression symptoms associated with increased right-sided parietal EEG asymmetry. J Abnorm Psychol. 2004 May;113(2):324-9. doi: 10.1037/0021-843X.113.2.324.

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• Levendowski DJ, Popovic D, Berka C, Westbrook PR. Retrospective cross-validation of automated sleep staging using electroocular recording in patients with and without sleep disordered breathing. Int Arch Med. 2012 Jun 25;5(1):21. doi: 10.1186/1755-7682-5-21.

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• Stepnowsky C, Levendowski D, Popovic D, Ayappa I, Rapoport DM. Scoring accuracy of automated sleep staging from a bipolar electroocular recording compared to manual scoring by multiple raters. Sleep Med. 2013 Nov;14(11):1199-207. doi: 10.1016/j.sleep.2013.04.022. Epub 2013 Aug 16.

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MeSH Terms

Conditions

Depression; Stress Disorders, Traumatic, Acute; Prolonged Grief Disorder; Alcoholism; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Alcohol-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders

Study Officials

• Kevin E Kip, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

• Paula L Cairns, PhD

  University of South Florida

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paula L Cairns, PhD

CONTACT

8139749716; paulacairns@usf.edu

Kevin E Kip, PhD

CONTACT

8139749266; kkip@usf.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: A prospective, longitudinal, descriptive study design.

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 10, 2019
• Study Start: November 1, 2019
• Primary Completion: April 30, 2020
• Study Completion: August 31, 2020
• Last Updated: November 4, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)