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Sponsor: National Institute of Mental Health (NIMH)
Conditions: Depression, Anxiety, Addiction, Emotion, Craving
Countries: United States
Background: Making decisions during daily life is a complicated behavior. Even simple choices can be affected by a range of emotions, stresses, and moods. Mental health issues such as depression and anxiety can lead people to make decisions that have negative effects on their lives. Learning how changes in feeling affect a person's decisions may help researchers find ways to help them make more positive choices. Objective: To learn how changes in a person's feelings and emotions affect their decisions. Eligibility: People aged 18 to 55 years who are healthy or who have some level of depressive, anxiety, substance-related, or addictive disorders. Design: All study activities can be done remotely; participants may use a smartphone app, a website, or telehealth. Participants will have a baseline visit. They will complete tasks that require decisions; these tasks are like games they play on their phone. They will also answer questions about their habits, how they feel, their sleep quality, and any problem behaviors. They may wear a smartwatch during the study; it will record data such as their movements and heart rate. For 12 weeks, a study app will prompt participants to respond. They will be asked to answer questions about how they are feeling, any problematic behaviors, or big life events; they will be asked to complete tasks that require making decisions. They may record a video or audio clip describing their day and how they feel. For 3 of the 12 weeks, participants will get prompts up to 6 times per day. For 9 weeks, they will get up to 3 prompts per day. They will have an end-of-study visit to discuss their experiences.
Sex: ALL
Age: 18 Years to 55 Years
Healthy volunteers: No
Study type: OBSERVATIONAL
* INCLUSION CRITERIA
In order to be eligible to participate in this study, an individual must meet all of the following criteria:
1. Understands study procedures as well as the risks and benefits associated with them. Is willing to comply with study procedures and is available for the duration of the study.
2. Currently resides in the United States.
3. Aged 18-55.
4. Individuals in good general health as evidenced by medical and psychiatric history, or individuals who endorsed current or lifetime clinical or subclinical symptoms related to Depressive Disorders, Anxiety Disorders, Substance-Related and Addictive Disorders.
5. Agreement to adhere to Lifestyle Considerations throughout study duration.
EXCLUSION CRITERIA
An individual who meets any of the following criteria will be excluded from participation:
1. Any unstable medical conditions (not well-controlled or are subject to frequent exacerbations, including uncontrolled hypertension, recent myocardial infarction, or unstable diabetes), severe chronic (long-term medical conditions that are either progressive or require ongoing medical treatment, including advanced cardiovascular disease, chronic obstructive pulmonary disease (COPD), or end-stage renal disease), or significantly impairing medical condition that could limit cognitive, mobility, and physiological measures (conditions that severely limit mobility or daily functioning, such as severe arthritis, advanced Parkinson's disease, or major neurocognitive disorders).
2. Any Traumatic Brain Injury (TBI), loss of consciousness, brain lesion, epileptic seizure, or any other conditions that are indicative of abnormal function or structure of the brain.
3. Self-reported acute intoxication, withdrawal, or another medically compromised condition at Enrollment / Baseline Visit.
4. Following psychiatric symptoms and disorder diagnosis:
* Any current serious ideation, intention or plan for homicide or intentional harm towards others as determined by SCID-V and the clinical judgement of qualified clinical team member.
* Imminent / High risk of self-harm or suicide as determined by SCID-V and the clinical judgement of qualified clinical team member.
* Current manic episode as determined by SCID-V and self-report questionnaires.
* Currently under inpatient care.
* Diagnosis (current and lifetime) and / or treatment for the following psychiatric disorders as defined in the DSM-5:
* Any symptoms compatible with Psychosis
* Neurodevelopmental Disorders (e.g. with learning or intellectual disability) impacting understanding of Decision-Making Tasks
* Schizophrenia Spectrum and Other Psychotic Disorders
* Dissociative Disorders
* Sleep-Wake Disorders, except for Breathing-Related Sleep Disorders
* Neurocognitive Disorders (e.g., dementia or cognitive decline) impacting understanding of Decision-Making Tasks
* Any significantly impairing psychiatric disorder, symptom or behavior, as determined by comprehensive clinical assessments, including severity scales, clinician judgment, and self-report measures.
5. Self-reported pregnancy or lactation.
6. Any disrespectful or unprofessional behavior towards any study team member.
7. Familial or any close personal relationship with a study team member.
8. Any condition or general impairment that might interfere with or limit individual's ability to engage in informed consent and study procedures.- Bethesda, Maryland, United States