AzTrials
AzTrials

Mental Health IssueAMOSNCT04512755

AIMS Medical Outcomes Study

An observational study of Mental Health Issue and PTSD, run by Advanced Integrative Medical Science Institute at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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 more about this study

Who is it for?
Any age
Conditions the study is for
Mental Health Issue, PTSD, Pain
How many people
500 participants
Where
1 siteUnited States
Study dates
1 Jul 2020to 31 Dec 2030
Phase
Observational
Are there results?
Not yet: the study is under way

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 Any age
  • All sexes
  • Child, Adult, Older adult

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

Who may be able to join

  • Patients enrolled in the study will meet the following criteria:
  • A new patient coming in for a first office call (FOC) or first consultation via telemedicine with an AIMS physician or advanced practice provider;
  • An established patient;
  • If over 18 years of age are able to understand study design adequately and provide signed informed consent to enrollment;
  • 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.

Who cannot join

  • Ineligible participants:
  • Cannot read or understand English well enough to read and sign the consent form and complete the questionnaires;
  • Unwilling to participate in the AIMS Institute observational study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Michelle Speaks, MBA contact

2064201321

mspeaks@aimsinstitute.net

Sunil K Aggarwal, MD, PhD contact

2064201321

saggarwal@aimsinstitute.net

United States1 site, 1 recruiting

  • AIMS Institute

    Seattle, Washington, 98102

    Michelle Speaks, MBA, 206-420-1321, mspeaks@aimsinstitute.net

    Sunil K Aggarwal, MD, PhD, 2064201321, saggarwal@aimsinstitute.net

    Recruiting

Other trials in United States

About this study

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.

Keywords
Naturopathic Oncology, Integrative Medicine, Integrative Psychiatry, Integrative Physical Medicine and Rehabilitation, Integrative Palliative Care Medicine, Serious Illness, Life Threatening Illness
Medical subject headings
Stress Disorders, Post-Traumatic, Pain, Chronic Pain, Chronic Disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Health Related Quality of Life

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

    Measured: 5 Years

Secondary outcomes (1)

  1. Treatment

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

    Measured: 5 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start1 Jul 2020
  3. Primary completion1 Jul 2025 (estimated)
  4. Study completion31 Dec 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
500 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04512755
Sponsor's protocol ID
AMOS
Acronym
AMOS
Status last verified
Jan 2023
First submitted
30 Jul 2020
Last updated
1 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

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.

    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

Questions about this trial

What is this clinical trial studying?

An observational study of Mental Health Issue and PTSD, run by Advanced Integrative Medical Science Institute 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 5 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: looking for participants now, as of the sponsor's last update on 1 Feb 2023. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Michelle Speaks, MBA (2064201321, mspeaks@aimsinstitute.net), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Health Related Quality of Life (time frame: 5 Years). 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 NCT04512755, which also lists 16 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 1 Feb 2023.

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