An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression

NCT05466851 | Recruiting

• 1 other identifier: Pro00059104
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This research study is studying how thoughts, feelings, surroundings, and individual biology may contribute to why and how people experience anxiety or depression. We are trying to find out the wide variety of reasons that people may experience anxiety or depression, and why different people are helped by different forms of treatment. We are trying to determine why people stay in treatment, and what factors contribute to a positive or negative response to treatment. These reasons may be due to thoughts, feelings, beliefs, personality, biology, social support network, life events, and barriers to treatment. A wide range of information about factors that impact anxiety and depression will be included. These include, among others, measures of inflammation, hormone levels, behavior, spoken language, personality, medical history, social determinants of health, and attitudes toward mental health and its treatment. The study involves psychological and psychiatric treatments in the form of psychotherapy and medication management. The participant will be asked to set specific goals for study treatment, and to provide videos between sessions about relevant medication, emotional, and sleep factors in their life. In summary, this study will collect biological, psychological, and social factors that may play a role in anxiety and depression. This will inform both individual's diagnosis and treatment and will be used in a later set of analyses that can inform diagnosis and treatment for other individuals who share similar characteristics.

Conditions

Depression; Anxiety Disorders; Stress Related Disorder

Keywords

Biomarkers; Biopsychosocial

Outcome Measures

Primary Outcomes (3)

• Treatment Engagement and Adherence

  To identify biopsychosocial correlates of treatment engagement and adherence through Neurocognitive measures of cognitive flexibility (cognitive control, executive functioning, task inhibition) and delayed gratification, biological markers of stress and inflammation, perceived psychological stress, anxiety, mood, loneliness, and stigma, and video recorded affective responses to prompts.

  Through Phase 1 completion, an average of 2-4 weeks

• Treatment Response

  To identify biopsychosocial correlates of treatment response through Neurocognitive measures of cognitive flexibility (cognitive control, executive functioning, task inhibition) and delayed gratification, biological markers of stress and inflammation, perceived psychological stress, anxiety, mood, loneliness, and stigma, and video recorded affective responses to prompts.

  Through Phase II, an average of 3-6 months

• Illness Remission & Treatment Maintenance

  To identify biopsychosocial correlates of illness remission and treatment maintenance through Neurocognitive measures of cognitive flexibility (cognitive control, executive functioning, task inhibition) and delayed gratification, biological markers of stress and inflammation, perceived psychological stress, anxiety, mood, loneliness, and stigma, and video recorded affective responses to prompts.

  Participants are to be followed by a clinician throughout their care over a period of weeks to months for the potential full course of treatment that is defined by specific clinical milestones.

Eligibility Criteria

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

Study Population

Participants seeking treatment for anxiety and depression at Singula Institute.

You may qualify if:

• to 65 years of age.
• Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
• At the initial study enrollment, subjects must have fulfilled DSM-5 criteria for Major Depression, single episode or recurrent.
• At the initial study enrollment, subjects may have fulfilled DSM-5 criteria for an Anxiety Disorder Comorbid Psychiatric Disorders, specifically Anxiety Disorders (Panic Disorder, Specific Phobia, Social Anxiety Disorder, Generalized Anxiety Disorder), Obsessive Compulsive Disorder, or a prior diagnosis of Post-Traumatic Stress Disorder, and/or Attention Deficit Hyperactivity Disorder may be enrolled as per assessment and agreement of evaluating clinicians.
• Agree to participate in clinical treatment (medication management and psychotherapy)

You may not qualify if:

• Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
• History of head trauma or stroke (also known as a cerebrovascular accident).
• Clinically significant abnormal laboratory tests.
• Subjects with one or more seizures without a clear and resolved etiology or current use of medication known to lower seizure threshold.
• Any use of opioid medication in the past 12 months
• Positive HIV test
• Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
• Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 12 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not have used illicit substances or known drugs of abuse in the 2 weeks prior to screen
• Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk.

Sponsors & Collaborators

• Singula Institute: lead
• Storyline Health: collaborator
• Bruin Health: collaborator

Study Sites (1)

Singula Institute, 353 Lexington Avenue (Room 600)

New York, New York, 10016, United States

RECRUITING

Related Publications (7)

• Keller AS, Leikauf JE, Holt-Gosselin B, Staveland BR, Williams LM. Paying attention to attention in depression. Transl Psychiatry. 2019 Nov 7;9(1):279. doi: 10.1038/s41398-019-0616-1.

  PMID: 31699968 BACKGROUND

• Drysdale AT, Grosenick L, Downar J, Dunlop K, Mansouri F, Meng Y, Fetcho RN, Zebley B, Oathes DJ, Etkin A, Schatzberg AF, Sudheimer K, Keller J, Mayberg HS, Gunning FM, Alexopoulos GS, Fox MD, Pascual-Leone A, Voss HU, Casey BJ, Dubin MJ, Liston C. Resting-state connectivity biomarkers define neurophysiological subtypes of depression. Nat Med. 2017 Jan;23(1):28-38. doi: 10.1038/nm.4246. Epub 2016 Dec 5.

  PMID: 27918562 BACKGROUND

• Zhuo C, Li G, Lin X, Jiang D, Xu Y, Tian H, Wang W, Song X. The rise and fall of MRI studies in major depressive disorder. Transl Psychiatry. 2019 Dec 9;9(1):335. doi: 10.1038/s41398-019-0680-6.

  PMID: 31819044 BACKGROUND

• Stein BD, Adams AS, Chambers DA. A Learning Behavioral Health Care System: Opportunities to Enhance Research. Psychiatr Serv. 2016 Sep 1;67(9):1019-22. doi: 10.1176/appi.ps.201500180. Epub 2016 May 2.

  PMID: 27133723 BACKGROUND

• Boes S, Mantwill S, Kaufmann C, Brach M, Bickenbach J, Rubinelli S, Stucki G. Swiss Learning Health System: A national initiative to establish learning cycles for continuous health system improvement. Learn Health Syst. 2018 Jun 21;2(3):e10059. doi: 10.1002/lrh2.10059. eCollection 2018 Jul.

  PMID: 31245587 BACKGROUND

• Posnack, S., Connecting health and care for the nation: a shared nationwide interoperability roadmap. 2015.

  BACKGROUND

• Friedman C, Rubin J, Brown J, Buntin M, Corn M, Etheredge L, Gunter C, Musen M, Platt R, Stead W, Sullivan K, Van Houweling D. Toward a science of learning systems: a research agenda for the high-functioning Learning Health System. J Am Med Inform Assoc. 2015 Jan;22(1):43-50. doi: 10.1136/amiajnl-2014-002977. Epub 2014 Oct 23.

  PMID: 25342177 BACKGROUND

Related Links

• The homepage for Singula Institute.

MeSH Terms

Conditions

Depression; Anxiety Disorders

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Study Officials

• Marc S Lener, M.D.

  CEO

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jen Tung, RN, MA

CONTACT

2125315826; info@singulainstitute.org

Jen Tung, RN, MA

CONTACT

2125315826; jen.tung@singulainstitute.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: CEO

Study Record Dates

• First Submitted: June 30, 2022
• First Posted: July 20, 2022
• Study Start: March 1, 2023
• Primary Completion (Estimated): March 31, 2032
• Study Completion (Estimated): March 31, 2032
• Last Updated: April 17, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)