Paying attention to attention in depression.
Arielle S Keller, John E Leikauf, Bailey Holt-Gosselin...
https://pubmed.ncbi.nlm.nih.gov/31699968Actively Recruiting
Age: 18Years - 65Years
All Genders
ID05466851
An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression
Led by Singula Institute · Updated on 2024-04-17
200
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Singula Institute
Lead Sponsor
S
Storyline Health
Collaborating Sponsor
AI-Summary
What this Trial Is About
This research explores how thoughts, feelings, surroundings, and individual biology contribute to anxiety and depression. It aims to understand why people experience these conditions differently, how they respond to treatment, and what factors influence treatment success or challenges. The study focuses on a wide range of biological, psychological, and social factors, including inflammation, hormone levels, behavior, personality, medical history, social support, and attitudes toward mental health. The study involves psychological and psychiatric treatments such as psychotherapy and medication management. Participants will set personal treatment goals and provide video updates between sessions about medication use, emotions, and sleep. The study follows three phases: initial diagnostic assessment and treatment engagement, active treatment with weekly sessions and biological sample collection until remission, and a remission-maintenance phase with less frequent sessions and ongoing monitoring. Participants will attend regular clinical sessions where symptoms, spoken language, and video recordings are collected. Biological samples will be taken during acute episodes and weekly until remission, then periodically during maintenance. The study tracks treatment engagement, response, and remission over weeks to months. Data and samples are securely stored and may be shared with authorized researchers while protecting participant privacy. The total participation period varies depending on individual treatment progress.
CONDITIONS
Brief Title
An Exploratory Study Examining Biopsychosocial Markers of Anxiety and Depression
Who Can Participate
Age: 18Years - 65Years
All Genders
Eligibility Criteria
You may qualify if you...
- 18 to 65 years of age
- Ability to understand and agree to all required tests and provide informed consent
- Diagnosis of Major Depression (single episode or recurrent) based on DSM-5 criteria at enrollment
- May have comorbid Anxiety Disorders, Obsessive Compulsive Disorder, PTSD, or ADHD as assessed by clinicians
- Willingness to participate in clinical treatment including medication management and psychotherapy
You will not qualify if you...
- Serious, unstable illnesses including liver, kidney, gastrointestinal, respiratory, heart, endocrine, neurological, immune, or blood diseases
- History of head trauma or stroke
- Significant abnormal laboratory test results
- Seizures without resolved cause or current use of medication lowering seizure threshold
- Opioid medication use within the past 12 months
- Positive HIV test
- Current psychotic features or diagnosis of schizophrenia or other psychotic disorders
- History of drug or alcohol dependency or abuse (except caffeine or nicotine) within past 12 months
- Use of illicit substances in the 2 weeks prior to screening
- Current serious suicidal or homicidal risk as judged by investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for diagnostic clarification and symptom assessment
Monitoring
Duration - 3 to 6 months
Participants undergo diagnostic clarification and symptom identification using written symptom inventories, spoken language, and audio/video recordings during weekly clinical sessions.
Weekly visits (in-person) during treatment period with additional biological sample collections when clinically indicated
Long-term Monitoring
Duration - Weeks to months following remission
Participants in remission attend biweekly to monthly treatment sessions where symptoms, spoken language, and audio/video recordings are collected to maintain remission.
Biweekly to monthly visits (in-person)
Trial Site Locations
Total: 1 location
1
Singula Institute, 353 Lexington Avenue (Room 600)
New York, New York, United States, 10016
Actively Recruiting
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Research Team
J
Jen Tung, RN, MA
J
Jen Tung, RN, MA
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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