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RecruitingNCT04512755AMOSUpdated Feb 1, 2023

AIMS Medical Outcomes Study

An observational study in Mental Health Issue, PTSD and Pain, sponsored by Advanced Integrative Medical Science Institute. Recruiting at 1 site in United States. Per ClinicalTrials.gov, last updated 2023-02-01.

Sponsored by Advanced Integrative Medical Science Institute · Observational

From the registry’s dates

  • Primary completion was expected by Jul 2025, 1 year 3 months ago, but the record still lists the study as recruiting.
  • Started Jul 2020; still recruiting 6 years 3 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
500
Sex
All
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Study summary

This epidemiologic research is being conducted as an observational prospective case series outcomes study of the use of advanced integrative specialty medical care and its effect on adult and pediatric patients with chronic or serious illnesses or mental health disorders.

Read the detailed description

There is growing interest in providing integrative medical care in conjunction with specialty medical care to expand the reach of integrative care to more chronically and seriously ill patient populations. At the AIMS Institute, the core specialties are naturopathy, palliative care, psychiatry, physiatry, and naturopathic oncology practiced via coordinated, team-based care by allopathic medical and psychiatric specialists, psychotherapists, specialized naturopathic physicians, advanced practice nurses, and targeted health educators, with the majority of care covered by insurance. Additionally incorporated are novel 'advanced' approaches, such as drug-assisted psychotherapy, medical cannabis education, sympathetic blocks, and some intravenous therapies.

This is an uncontrolled, prospective case series outcomes study of health-related quality of life outcomes in patients who receive care at AIMS Institute. A clinic-wide chart audit of patient characteristics and outcomes will be conducted prior to the start of enrollment.

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Conditions studied

  • Mental Health Issue
  • PTSD
  • Pain
  • Chronic Pain
  • Chronic Disease

Keywords

  • Naturopathic Oncology
  • Integrative Medicine
  • Integrative Psychiatry
  • Integrative Physical Medicine and Rehabilitation
  • Integrative Palliative Care Medicine
  • Serious Illness
  • Life Threatening Illness
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In context

Chronic Pain

2,930 studies on the registry are indexed under Chronic Pain; 701 are open to participants now.

This study's planned enrollment of 500 is above the median of 126 across 688 observational studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Advanced Integrative Medical Science Institute is the lead sponsor of 3 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

Study population

All patients who seek care at AIMS Institute and meet inclusion/exclusion criteria are eligible to participate in this study.

Inclusion criteria

  • Patients enrolled in the study will meet the following criteria:

    1. A new patient coming in for a first office call (FOC) or first consultation via telemedicine with an AIMS physician or advanced practice provider;
    2. An established patient;
    3. If over 18 years of age are able to understand study design adequately and provide signed informed consent to enrollment;
    4. If younger than 18 years of age informed consent from a parent or guardian who is able to understand the study design adequately and provide signed informed consent for the pediatric patient.

Exclusion criteria

Exclusion Criteria:

  • Ineligible participants:

    1. Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
    2. Unwilling to participate in the AIMS Institute observational study.
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
500 participants (estimated)
Patient registry
No
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What researchers measure

Primary outcomes

  1. Health Related Quality of Life

    Measure quality of life using GAD-7, PHQ-9, and short form questionnaire.

    Time frame: 5 Years

Secondary outcomes

  1. Treatment

    Describe treatments prescribed and provided by AIMS Institute physicians abstracted from chart review.

    Time frame: 5 Years

07

Study locations

1 of 1 sites recruiting
  • AIMS Institute
    Seattle, Washington 98102, United States
    • Michelle Speaks, MBA · Contact · mspeaks@aimsinstitute.net · 206-420-1321
    • Sunil K Aggarwal, MD, PhD · Contact · saggarwal@aimsinstitute.net · 2064201321
    • Therry Eparwa, DNP · Principal investigator
    • Leanna J Standish, ND, PhD · Sub investigator
    • Sunil K Aggarwal, MD, PhD · Sub investigator
    Recruiting
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References and documents

Publications

  • De Lima L, Bennett MI, Murray SA, Hudson P, Doyle D, Bruera E, Granda-Cameron C, Strasser F, Downing J, Wenk R. International Association for Hospice and Palliative Care (IAHPC) List of Essential Practices in Palliative Care. J Pain Palliat Care Pharmacother. 2012 Jun;26(2):118-22. doi: 10.3109/15360288.2012.680010. PubMed 22764847 ↗
  • Stjernsward, J. & Clark, D. (2005). Palliative medicine: a global perspective. In Doyle, D., Hanks, G., Cherny, N., & Calman, K. (Eds.). Oxford textbook of palliative medicine (3rd ed., pp. 1197-224). Oxford University Press.
  • Bercovitz A, Sengupta M, Jones A, Harris-Kojetin LD. Complementary and alternative therapies in hospice: The national home and hospice care survey: United States, 2007. Natl Health Stat Report. 2011 Jan 19;(33):1-20. PubMed 25585442 ↗
  • Leskowitz E. (2002) Complementary and alternative medicine in rehabilitation. Churchill Livingstone.
  • Monti, D.A. & Newberg, A.B. (2018). Integrative psychiatry and brain health (2nd ed.) Weil Integrative Medicine Library, Oxford University Press.
  • Scotton, B.W., Chinen, A.B., &Battista, J.R. (Eds.). (1996). Textbook of transpersonal psychiatry and psychology. Basic Books.
  • Association of Accredited Naturopathic Medical Colleges. (2019). Naturopathic medicine: Become the doctor you want to have. [Whitepaper]. Association of Accredited Naturopathic Medical Colleges. Retrieved May 13, 2020 from: https://aanmc.org/wp-content/uploads/2019/02/Naturopathic-Medicine-White-Paper.pdf
  • Standish, L.J. & Aggarwal, S.K. (2019). Advanced integrative oncology treatment for adult and pediatric patients with cancer: A prospective outcomes study. AIMS Institute Clinical Study Protocol.
  • Wolfson, P. & Hartelius, G. (Eds). (2016). The ketamine papers: Science, therapy, and transformation. Multidisciplinary Association for Psychedelic Studies.
  • Ghebreyesus, Tedros Adhanom. (2019, January 24). Tedros Adhanom Ghebreyesus to António Guterres. World Health Organization. Retrieved from https://www.who.int/medicines/access/controlled-substances/UNSG_letter_ECDD41_recommendations_cannabis_24Jan19.pdf
  • Cyr C, Arboleda MF, Aggarwal SK, Balneaves LG, Daeninck P, Neron A, Prosk E, Vigano A. Cannabis in palliative care: current challenges and practical recommendations. Ann Palliat Med. 2018 Oct;7(4):463-477. doi: 10.21037/apm.2018.06.04. Epub 2018 Jun 28. Erratum In: Ann Palliat Med. 2019 Apr;8(2):215-217. doi: 10.21037/apm.2019.01.06. PubMed 30180728 ↗
  • Wolever RQ, Abrams DI, Kligler B, Dusek JA, Roberts R, Frye J, Edman JS, Amoils S, Pradhan E, Spar M, Gaudet T, Guarneri E, Homel P, Amoils S, Lee RA, Berman B, Monti DA, Dolor R. Patients seek integrative medicine for preventive approach to optimize health. Explore (NY). 2012 Nov-Dec;8(6):348-52. doi: 10.1016/j.explore.2012.08.005. PubMed 23141791 ↗
  • Abrams DI, Dolor R, Roberts R, Pechura C, Dusek J, Amoils S, Amoils S, Barrows K, Edman JS, Frye J, Guarneri E, Kligler B, Monti D, Spar M, Wolever RQ. The BraveNet prospective observational study on integrative medicine treatment approaches for pain. BMC Complement Altern Med. 2013 Jun 24;13:146. doi: 10.1186/1472-6882-13-146. PubMed 23800144 ↗
  • Edman JS, Roberts RS, Dusek JA, Dolor R, Wolever RQ, Abrams DI. Characteristics of cancer patients presenting to an integrative medicine practice-based research network. Integr Cancer Ther. 2014 Sep;13(5):405-10. doi: 10.1177/1534735414537876. Epub 2014 Jun 9. PubMed 24913179 ↗
  • Dusek JA, Abrams DI, Roberts R, Griffin KH, Trebesch D, Dolor RJ, Wolever RQ, McKee MD, Kligler B. Patients Receiving Integrative Medicine Effectiveness Registry (PRIMIER) of the BraveNet practice-based research network: study protocol. BMC Complement Altern Med. 2016 Feb 4;16:53. doi: 10.1186/s12906-016-1025-0. PubMed 26846166 ↗
  • Ameli R, Sinaii N, Luna MJ, Cheringal J, Gril B, Berger A. The National Institutes of Health measure of Healing Experience of All Life Stressors (NIH-HEALS): Factor analysis and validation. PLoS One. 2018 Dec 12;13(12):e0207820. doi: 10.1371/journal.pone.0207820. eCollection 2018. PubMed 30540764 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 1, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04512755
Lead sponsor
Advanced Integrative Medical Science Institute
Responsible party
Sponsor
First posted
Aug 14, 2020
Start date
Jul 1, 2020
Primary completion
Jul 1, 2025 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Feb 1, 2023

Study contacts

Michelle Speaks, MBA
Contact
mspeaks@aimsinstitute.net
2064201321
Sunil K Aggarwal, MD, PhD
Contact
saggarwal@aimsinstitute.net
2064201321
Therry Eparwa, DNP, FNP-BC
principal investigator · AIMS Institute
Sunil K Aggarwal, MD, PhD
study director · AIMS Institute
Leanna J Standish, ND, PhD, LAc
study director · AIMS Institute

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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