Depressive SymptomsM-ARTNCT04121884
Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
A study testing Accelerated Resolution Therapy in people with Depressive Symptoms and Stress Disorder, Acute, run by University of South Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depressive Symptoms, Stress Disorder, Acute, Prolonged Grief Disorder
- What is being tested?
- Accelerated Resolution Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Aug 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of South Florida
Tampa, Florida, 33612
Paula L Cairns, PhD, 727-543-8680, paulacairns@usf.edu
Kevin E Kip, PhD, 8139749266, kkip@usf.edu
About this study
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.
Read the 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.
- Conditions
- Depressive Symptoms, Stress Disorder, Acute, Prolonged Grief Disorder, Alcohol Abuse, Stress Disorders, Post-Traumatic
- Being tested
- Accelerated Resolution Therapy
- Keywords
- Heart Rate Variability, Sleep, Electrocardiogram, Electroencephlogram, Alcohol Abuse, Prolonged Grief Disorder, Stress Disorder, Acute, Stress Disorders, Post-Traumatic, Depressive Symptoms, Power Spectral Density
- Medical subject headings
- Depression, Stress Disorders, Traumatic, Acute, Prolonged Grief Disorder, Alcoholism, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerated Resolution TherapyBehavioural
Also called ART
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Accelerated Resolution Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Autonomic Nervous System (ANS) Imbalance
HRV, EEG power spectral densities, and sleep architecture
Measured: 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
HRV and EEG power spectral densities
Measured: During first ART session at 1 week and during 4th ART session at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start1 Nov 2019
- Primary completion30 Apr 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (22)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A prospective, longitudinal, descriptive study design.
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Kip, University of South Florida
- Investigators
- Kevin E Kip, PhD, Principal investigator, University of South FloridaPaula L Cairns, PhD, Principal investigator, University of South Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121884
- Sponsor's protocol ID
- Pro00040159
- Acronym
- M-ART
- Status last verified
- Nov 2019
- First submitted
- 7 Oct 2019
- Last updated
- 4 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 23482431Kip 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.
PubMed 26327548Kip 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.
PubMed 29635395Kip 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.
PubMed 27601310Kip 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.
PubMed 24402982Hernandez 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.
PubMed 27250615Kip 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.
PubMed 24959325Schimmels 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.
PubMed 30295890Blechert 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.
PubMed 17991823Chalmers 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.
PubMed 25071612Thayer 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.
PubMed 19910061Thayer 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.
PubMed 22178086Kemp 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.
PubMed 20708650Lobo 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.
PubMed 26025367Todder 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.
PubMed 22423551
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurophysiological Mechanisms of Accelerated Resolution Therapy (ART)
- ClinicalTrials.gov ID
- NCT04121884
- Acronym / sponsor ID
- M-ART / Pro00040159
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 30 Apr 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 10 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A prospective, longitudinal, descriptive study design.
| Arm | Type | Receives |
|---|---|---|
| ART Treatment | Experimental | Behavioral: Accelerated Resolution TherapyA 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerated Resolution TherapyAlso: ARTThe 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. | Behavioural | ART Treatment |
Primary outcome
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
1 secondary outcome
Changes in ANS During ART
Time frame: During first ART session at 1 week and during 4th ART session at 5 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2019.
- Background: PubMed 23482431Kip 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.
- Background: PubMed 26327548Kip 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.
- Background: PubMed 29635395Kip 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.
- Background: PubMed 27601310Kip 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.
- Background: PubMed 24402982Kip 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.
- Background: PubMed 27250615Hernandez 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.
- Background: PubMed 24959325Kip 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.
- Background: PubMed 30295890Schimmels 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.
- Background: PubMed 17991823Blechert 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.
- Background: PubMed 25071612Chalmers 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.
- Background: PubMed 19910061Thayer 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.
- Background: PubMed 22178086Thayer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin E Kip, PhD principal investigator
University of South Florida
Paula L Cairns, PhD principal investigator
University of South Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerated Resolution Therapy in people with Depressive Symptoms and Stress Disorder, Acute, run by University of South Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 4 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paula L Cairns, PhD (8139749716, paulacairns@usf.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04121884, which also lists 22 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2019.