NCT05466851 · Singula Institute
An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression
(BPS)
What this study is about
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.
View original scientific description
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.
Primary outcome measures
Treatment Engagement and Adherence
Time frame: Through Phase 1 completion, an average of 2-4 weeks
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.
Treatment Response
Time frame: Through Phase II, an average of 3-6 months
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.
Illness Remission & Treatment Maintenance
Time frame: 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.
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 18 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)
Exclusion criteria
- 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.
Where
- New York, New York
Collaborators
Storyline Health, Bruin Health
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 17, 2024 · Source of record for eligibility and locations